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ADHD Research


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ADHD

What Is Attention-Deficit Hyperactivity Disorder (ADHD)?

 Lydia Furman, MD , J Child Neurol.  2005;20(12):994-1003.  ©2005 BC Decker, Inc., Posted 02/02/2006

 Lydia Furman, MD, Department of Pediatrics, Case Western Reserve University School of Medicine, Rainbow Babies and Children's Hospital, Cleveland, OH

Abstract:  Attention-deficit hyperactivity disorder (ADHD) is described as the most common neurobehavioral condition of childhood. We raise the concern that ADHD is not a disease per se but rather a group of symptoms representing a final common behavioral pathway for a gamut of emotional, psychological, and/or learning problems. Increasing numbers of children, especially boys, are diagnosed with ADHD and treated with stimulant medications according to a simplified approach. Methodical review of the literature, however, raised concerning issues. "Core" ADHD symptoms of inattentiveness, hyperactivity and impulsivity are not unique to ADHD. Rates of "comorbid" psychiatric and learning problems, including depression and anxiety, range from 12 to 60%, with significant symptom overlap with ADHD, difficulties in diagnosis, and evidence-based treatment methods that do not include stimulant medications.

No neuropsychologic test result is pathognomic for ADHD, and structural and functional neuroimaging studies have not identified a unique etiology for ADHD. No genetic marker has been consistently identified, and heritability studies are confounded by familial environmental factors.

 The validity of the Conners' Rating Scale-Revised has been seriously questioned, and parent and teacher "ratings" of school children are frequently discrepant, suggesting that use of subjective informant data via scale or interview does not form an objective basis for diagnosis of ADHD. Empiric diagnostic trials of stimulant medication that produce a behavioral response have been shown not to distinguish between children with and without "ADHD." In summary, the working dogma that ADHD is a disease or neurobehavioral condition does not at this time hold up to scrutiny of evidence. Thorough evaluation of symptomatic children should be individualized, and include assessment of educational, psychologic, psychiatric, and family needs.

Does Medication Work?

A Critical Analysis of the NIMH Multimodal Treatment Study for ADHD (The MTA Study). This is one of the, if not the largest study ever conducted on the effectiveness of medications with children meeting the label ADHD.  Period. Don't by the National Institute of Health, over several years.  The best...   

Full study can be found here: Jensen et al: Findings from the NIMH Multimodal Treatment Study of ADHD (MTA): Implications and Applications for Primary Care ProvidersDevelopmental and Behavioral Pediatrics, Vol. 22, No. 1, February 2001

 by Peter R. Breggin, M.D.

      After many months of positive publicity in the psychiatric and the general media, the results of the Multimodal Treatment Study for Attention-Deficit Hyperactivity Disorder (The MTA Study) were finally published in December 1999 (MTA Cooperative Group, 1999a&b).  The study was sponsored by the National Institute of Mental Health (NIMH) at six separate sites.  At each site, the study compared four treatment conditions: (1) medication management alone, (2) combined medication management and behavioral therapy, (3) behavioral treatment, and (4) community care.  The average age of the children was eight and 80% were boys.

       The aim of the study was to "resolve controversies and clinical quandaries about the relative value of medication and behavioral treatments" (National Institute of Mental Health, undated).   The proponents of the study claim that it demonstrated the superiority of stimulant treatment over behavioral treatments and routine community treatment.

      However, an examination of the MTA study reveals several gross methodological flaws that undermine its scientific validity and limit any conclusions that may be drawn from it.  The following is a general critique of the MTA study.

I. The MTA was not a placebo-controlled, double-blind clinical trial.

      The MTA study fails to meet the commonly accepted criteria for a scientific study of medication efficacy or effectiveness.  It was not a placebo-controlled double-blind clinical trial (MTA Cooperative Group, 1999a).  First, there was no placebo control group and no non-treatment control group.  Second, to reach their conclusions, the investigators relied upon evaluations made by teachers and parents who were not blind to the treatment.  That is, the raters whom the investigators relied upon knew whether or not the children were taking medication.   In short, the MTA was an "open label" study.   It could not be used, for example, for FDA approval of a drug.

      Bias on the part of researchers, observers or evaluators, and research subjects?whether conscious or unconscious?often influence the outcome of "open label" studies.   Researchers commonly want to prove that the treatment under investigation is effective.  In the MTA studies,  the sponsors and all the principal investigators were staunch advocates of medication.   Evaluators of efficacy often  make observations that confirm what they anticipate finding, such as improvement in subjects treated with drugs.   The research subjects themselves often give responses that they know will please their doctors.  They also tend to respond to their own belief that the drug is safe and effective, and that it will help them or their children.  Therefore, open label studies have been discredited for purposes of evaluating effectiveness.    As Nies and Spielberg (1996, p. 45) observe,  ?Placebo effects, which occur in a large percentage of patients, can confound many studies?particularly those that involve subject responses; controls must take this into account? (for additional discussions of  placebo, double-blind procedures, and research standards, see Fisher and Greenberg, 1989).

      I have been informed that the principal investigators in the MTA study have claimed that it would have been unethical to use a placebo group because stimulants have been proven effective as a treatment for ADHD.  In reality, placebo groups are commonly used in ADHD and stimulant research. For example, I recently reviewed eight double-blind placebo controlled studies of stimulants for ADHD that were conducted from 1990-98 (Breggin, 1999a&b), including clinical trials carried out by the National Institute of Mental Health (Borcherding, Keysor, Rapoport, Elia, and Amass, 1990; Castellanos, Giedd, Elia, Marsh, Ritchie, Hamburger, & Rapoport, 1997).  A well-known double-blind placebo-controlled study of stimulants for children diagnosed with ADHD lasted over fifteen months (Gillberg, Melander, von Knorring, Janols, Thernlund, Hagglof, Eidevall-Wallin, Gustafsson, & Kopp, 1997). It was not criticized for withholding medication from some of the children. Furthermore, placebo-controlled trials are routinely carried out in psychiatry for far more dangerous ?disorders? than ADHD, including ?major depression? and ?mania.?

      Furthermore, a number of the children in the MTA study went without medication while they were in the community and behavior treatment groups. It would have been no more ?unethical? to add an actual placebo group.

      Ultimately, the lack of a placebo control group marred the study regardless of the motivation behind omitting the group.  If the study could not be done in a manner that generated useful data and valid conclusions, it should not have been done at all.
 Finally, there can be no ethical problem surrounding the use of double-blind procedures. Yet this basic methodology was also omitted.

II. The blind classroom raters found no difference in any of the treatment groups, i.e., behavioral interventions were equal to medication interventions.

      The MTA used one group of "blinded ratings of school-based ADHD and oppositional/aggressive symptoms..." (MTA Cooperative Group, 1999a, p. 1074).  The blind raters observed the children in the classroom only.  The data from these raters are produced in Table 5 (pp. 1082-3) of the study.  The blind raters found no difference between any of the treatment groups on any of the variables involving ADHD or oppositional behavior. However, this extremely important finding, that the only potentially objective raters found no drug effect, was not considered in the study conclusions.   Nonetheless, the findings of the blind classroom raters are the most important in the study, confirming that stimulant drugs offer no observable advantages over other interventions, including behavioral therapy and non-specific community treatments.

III. There was no control group of untreated children.

      There was no non-treatment control group.  The MTA compared various treatments, but did not compare treatment to no treatment.  Two-thirds of the community-treated group received a variety of medications, as well as other interventions, and cannot be considered a non-treatment control group.   Basically, the study compared three drug conditions to behavioral interventions, but failed to compare the drug treatment to placebo.

IV. Thirty-two percent of the Medication Management group was already on medication for ADHD at the start of the MTA.

      Table 3 (p. 1079) shows that of 144 medication management subjects, 46 (32%) were on medication for ADHD at the start of the selection process.  This is generally not acceptable in a study of medication effects and would be expected to corrupt the study.   Since the children were already receiving medication, it is highly probably that their parents had already determined to their own satisfaction that the drugs were helpful.  Therefore they could not participate objectively in a ?random? drug study.

V. The Medication Management group was highly selective (in ways that are not fully described) and probably not typical of children who seek services for "ADHD."

      The study initially screened 4,541 children.  These children were referred from a variety of sources, such as public advertisements, clinics, and schools.  The aim was to draw from a broad spectrum of the kind of children whose parents bring them for services for "ADHD."  But of these 4,541 children, only 579 subjects (12.8%) were selected to enter the trials.

      The small percentage of applicants actually selected for the study suggests that the children in the trials do not reflect a representative community group of children routinely treated for ?ADHD.? As already noted, many of the children were already taking stimulant medications.   As a result, many of the children who entered the trials probably had parents who were already favorable toward medication.

VI. The Medication Management group was relatively small.

      The actual medical management group is much smaller than might be suspected based on the seemingly large scale of the study.  Of the 579 who entered the clinical trials, only 144 entered medication management, i.e., received medication alone (others received medication in combination with other treatments or behavioral therapy alone).  Thirteen of these dropped out before starting, limiting the actual start group to 131.  Eight more dropped out during the study for a total of only 123 finishers in medication management.  Overall, of the 4,541 children originally screened, only 12.8 percent entered the study and only 2.7 percent (123) completed the medication management trial.

       In addition, many of the children were comorbid for other psychiatric diagnoses, so that the group of children diagnosed solely with ADHD was much smaller than the total of 123 finishers.

VII. The children did not rate themselves improved.

      The children self-rated themselves on an anxiety scale (the MASC, Table 5 in the study).  They did not rate themselves differently in any treatment category at any time.  That is, the children did not rate themselves as doing better on the drugs than on any other treatment. This result supports the use of the safer non-drug treatment.

      Furthermore, I received inside information that the children also rated themselves on a depression scale.  This information was confirmed by a handout provided by the Columbia project (New York State Psychiatric Institute and Columbia University Division of Child & Adolescent Psychiatry, 1994).  However, no data are reported in the study concerning the depression scale.

      Because stimulants commonly cause depression in children, the authors of the MTA study should publish any data they posses on this issue.  If the children did rate themselves on a depression scale, one might raise the question: ?Were the depression self-rating scales dropped because they indicated a worsening of the children's condition?"

VIII. Most of the subjects were boys.

      Boys represent a disproportional number of the children who are medicated with stimulants.   Stimulants are known to be temporarily effective in suppressing overall normal spontaneous behavior in children and animals.   This drug-induced suppression of socialization, play, autonomy, and spontaneity makes normal boys easier to manage under certain circumstances, such as a home or classroom setting that does not meet their needs for spontaneous activity or provide them adequate discipline and engaging education (Breggin, 1999a&b).   In part to counter the argument that stimulants are used for the behavioral or social control of normal boys ,  attempts were made to include more girls in the MTA studies.  Despite efforts to recruit more girls, 80% of the subjects were boys.  This focus on treating boys reconfirms that stimulants are used to suppress the relatively higher activity rates of normal boys compared to girls.

IX. Drug treatment was continuous for fourteen months; behavioral treatments were stopped earlier.

      The MTA claims to have compared behavioral and medication treatments.  However, it did not compare drugs and behavioral treatments  for the same length of time.  Only the drug treatment persisted for 14 months.  In the last few months, behavioral treatments were spaced out to once a month or stopped.   Furthermore, parental attendance was inconsistent.  Continuing the drug treatment while discontinuing the behavioral treatment gives the drug treatment an unfair advantage.

X. The behavioral treatments were flawed.

      The study utilized behavioral treatments developed by Russell A. Barkley.  Barkley has used these techniques for decades to try to show that drugs are better than behavioral treatments.  He does this by comparing drug treatment to his own inadequate programs of behavioral treatment.  Barkley's behavioral approach is doomed to failure because it treats the child as a defective object suitable for control by parents and teachers rather than as a sentient being in conflict with adults at home and/or at school.  Barkley?s behavioral approach ignores everything that is known about family systems and the necessity of changing the overall patterns of relationship in the family, starting with the parents (Breggin, 2000).  Nonetheless, these limited behavioral approaches did as well as all the other treatments, according to the only "blind" observers (see above).  Once again, the study shows no advantage to drugs , thus favoring non-toxic behavioral  interventions, and perhaps no treatment at all.

XI.  Most children suffered from adverse drug reactions (ADRs).

      Sixty-four percent of children were reported to have some ADRs, 11.4% moderate, 2.9% severe.  The authors of the study dismiss the severe reactions because 6 of 11 were in the category of "depression, worrying, irritability."  They explain these "could have been due to nonmedication factors."  In reality, placebo-controlled double-blind clinical trials show depression, worrying, and irritability are common stimulant ADRs (trials reviewed in Breggin 1999a&b).   Their dismissal of known stimulant-induced ADRs also points to the strong biases of the investigators.

XII.  There were no trained observers for ADRS.

      ADRs were recorded by teachers and parents on a two-page check list .  There was no apparent training for this process.  In addition, parents and teachers were reassured in writing that the drug was safe and that ADRs were not serious, creating a bias in favor of the drug?s safety.  Furthermore, many ADRs--such as behavioral suppression, loss of spontaneity, apathy, and increased obsessive behavior--are mistakenly interpreted as improvements by parents and teachers.   The use of aware, experienced professionals, rather than parents and teachers, is absolutely necessary in order to determine the frequency and severity of ADRs (Borcherding, Keysor, Rapoport, Elia, and Amass, 1990; studies reviewed in Breggin, 1999a&b).

      In clinical practice, I have found that asking children about any potential adverse drug reactions is central to the assessment.   Often the child is having drug-related problems, such as headaches or  ?blah? feelings, but does not understand their source or tell anyone about them until questioned by the doctor.  The MTA study made no effort to ask the children what drug effects they might be experiencing.

      The study failed to carry out an objective evaluation of long-term adverse effects that have already been demonstrated in short-term studies.  For example, the study should have gathered data on physical parameters such as height and weight (growth), blood pressure, cardiac status, and abnormal movements, as well as on psychological parameters such as cognitive and affective functioning, including over-focusing (perseveration) and depression.  None of this was done.

      Overall, from the opening statement in the paper to its conclusion, it is obvious that the investigators did not intend to evaluate the single most important issue surrounding the long-term use of stimulant drugs--the risks they pose to the children.

XIII. There was no improvement in academic performance.

      In a note to Table 4 (MTA Cooperative Group, 1999a,) the authors of the MTA study admit there was no improvement or difference in academic performance in spelling or math.  The table itself seems to indicate marginal improvement in reading. However, according to Bertram Karon (personal communication, January 24, 2000), the statistical analysis was flawed (due to the use of a Bonferroni correction of 6 that was too small).  Overall, no academic improvement was found as a result of any treatment and no differences were found among the treatments.

XIV.  There was very little effect on social skills.

      Social skill differences among the groups were limited to a significant difference favoring combined treatment over standard community care.  Neither was better than behavioral or medical management treatment (MTA Cooperative Group, 1999a).

      Of great importance, the peer group sociometrics analysis yielded no advantage to any of the treatment groups.   The other children did not rate the medicated children as improved.

XV. All the principal investigators were well-known drug advocates.

      How could so many experienced professionals produce a study with so many flaws? The framer of the MTA studies, Peter Jensen (then at NIMH), and all the principal investigators are drug advocates who touted the positive results of the study even before it was completed or published.  The six principal investigators included Laurence Greenhill, C. K. Conners, William Pelham, Howard Abikoff, James Swanson, and Stephen Hinshaw (MTA Cooperative Group, 1999am, p. 10077). They have devoted their careers to encouraging the concept of ADHD and the drugging of children.  Some, like Conners, have been doing so for four decades.

      Laurence Greenhill of the New York State Psychiatric Institute and Columbia University represents the kind of conflict of interest that exists among MTA researchers.   Before the data were later removed from the web site during controversy over dangerous research on children at the institute and the university, the New York State Psychiatric Institute and Columbia University web site originally listed the funding of its researchers as of December 21, 1998 (NYSPI Sponsored Research, 1998).  Greenhill had research funds or other financial support from six drug companies: Richwood, Bristol-Myers, Solvay, Wyeth-Ayerst, Glaxo, and Eli Lilly.

XVI. The parents and teachers were exposed to prodrug propaganda.

      The families and teachers were exposed to the pro-drug biases of these investigators in the materials given to them before they enrolled in the study.  The "Teacher Information" for the MTA study presents the usual claims about how much harm ADHD causes children (NIMH MTA Study, undated, a).  It states the children will be treated with a "safe and effective dose of medication..." [bold in original].  This kind of built-in bias invalidated the observations made by the teachers concerning safety and efficacy, especially in an open label study.

      The "Information for Parents" handout had similar built-in biases, including a reference to biochemical imbalances and genetic factors in "ADHD" (NIMH MTA Study, undated, a).  In fact, based on the information handouts given out by Columbia and the NYSPI for the MTA, the parents in this study were not given  the opportunity for informed consent for the risks posed to their children by the drugs.

Discussion

      The MTA study has been highly promoted by advocates of drug therapy as a demonstration of the superiority of stimulant treatment for ADHD.  In fact, the study failed to meet the basic criteria for a drug trial.  It was not placebo-controlled and lacked a non-treatment control group.  It was not double blind. Teachers and parents provided the ratings relied upon by the study, but both groups knew whether or not the children were taking medications.  The MTA study was "open label" and would not have qualified, for example, as a study for the FDA-approval process.  As research purporting to demonstrate the effectiveness of stimulant drugs, it is scientifically unsound.

       Furthermore, the blind raters in the study who observed behavior in the classroom found no difference over fourteen months between any of the treatment conditions.  In other words, the observations generated by the most objective observers showed that the medicated children did no better than the other children in the study. Similarly, the peers of the subjects did not rate the children as improved in any of the treatment groups.

      Positive ratings for the medication groups came from the parents and teachers who were heavily propagandized in favor of the drugs and who knew which children were receiving them.  In many cases, the children were already on the drugs, indicating teacher and parent biases in favor of medication.

      The study also failed to evaluate adverse drug effects in a scientific manner. Lacking observations by trained professionals, while relying upon potentially biased and untrained parents and teachers, the study is not a valid source of data concerning stimulant-induced adverse effects.

      Unfortunately, the MTA study also failed to examine the kind of interventions that, in actual clinical practice, prove very effective in helping children labeled with ADHD.  These interventions include individualized family counseling aimed at improving relationships in the family and individualized educational approaches that inspire children to engage themselves in school (Breggin, 1998, 2000).

      In summary, the MTA study failed to adhere to basic scientific standards for clinical trials of medication efficacy and cannot be used to draw valid conclusions about stimulant efficacy. Furthermore, the data it generated tends to indicate that stimulant medication produced no different results than any of the other intervention.   The MTA study does not demonstrate the superiority, or even the usefulness, of stimulant medication in the treatment of children labeled with ADHD or any other presumed psychiatric disorder.

Bibliography

 Borcherding, B.V., Keysor, C.S., Rapoport, J.L., Elia, J., and Amass, J. (1990).  Motor/vocal tics and compulsive behaviors on stimulant drugs: Is there a common vulnerability?  Psychiatric Research, 33, 83-94.
 Breggin, P.R. (1998). Talking back to Ritalin.  Monroe, Maine: Common Courage Press.
 Breggin, P.R. (1999a). Psychostimulants in the treatment of children diagnosed with ADHD: Risks and mechanism of action."  International Journal of Risk and Safety in Medicine, 12 (1), 3-35, 1999.
 Breggin, P.R. (1999b).  Psychostimulants in the treatment of children diagnosed with ADHD: Part I: Acute risks and psychological effects.  Ethical Human Sciences and Services, 1, 13-33.
 Breggin, P.R. (2000). Reclaiming our children: A healing solution for a nation in crisis.  Cambridge, MA: Perseus Books.
 Castellanos, F.X., Giedd, J.N., Elia, J., Marsh, W.L., Ritchie, G.F., Hamburger, S.D., & Rapoport, J.L. (1997). Controlled stimulant treatment of ADHD and Comorbid Tourette?s syndrome: Effects of stimulant and dose.  Journal of the American Academy of Child and Adolescent Psychiatry, 36, 589-596.
 Fisher, S.,  and Greenberg, R. P.  (Eds.) (1989).  The limits of biological treatments for psychological distress: Comparisons with psychotherapy and placebo.  Hillsdale, New Jersey: Lawrence Erlbaum Associates.
 Gillberg, C., Melander, H., von Knorring, A-L., Janols, L-O., Thernlund, G., Hagglof, B., Eidevall-Wallin, L., Gustafsson, P., & Kopp S. (1997). Long-term stimulant treatment of children with attention-deficit hyperactivity disorder symptoms: A randomized, double-blind, placebo-controlled trial.  Archives of General Psychiatry 54, 857-864.
 MTA Cooperative Group. (1999a). A 14-Month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder.  Archives of General Psychiatry, 56, 1073-1086.
 MTA Cooperative Group. (1999b). Moderators and mediators of treatment response for children with attention-deficit/hyperactivity disorder: the multimodal treatment study of children with attention-deficit hyperactivity disorder.  Archives of General Psychiatry, 56, 1088-1096.
 MTA side effects rating scale--parent. (undated). Obtained from http://pioria.cpmc.columbia.edu/mta/SIDE_P.html on March 1, 1999.
 MTA side effects rating scale--teacher. (undated). Obtained from http://pioria.cpmc.columbia.edu/mta/SIDE_P.html on March 1, 1999.
 National Institute of Mental Health. (undated).  Multimodal treatment study for attention-deficit hyperactivity disorder (the MTA study).  Obtained from http://pioria.cpmc.columbia.edu/mta/basicq.html on March 1, 1999.
 New York State Psychiatric Institute and Columbia University Division of Child & Adolescent Psychiatry. (1994).  Grand Rounds: The multimodal treatment study of attention deficit hyperactivity disorder (MTA Study)--An NIMH cooperative agreement grant. (unpublished; distributed on March 9, 1994).
 Nies, A.S., and Spielberg, S. P. (1996).  Principles of therapeutics.  In  Hardman, J.G., and L. E. Limbird (Eds.),   Goodman & Gilman?s the pharmacological basis of  therapeutics,  ninth edition, pp. 43-62.  New York: McGraw?Hill.
 NIMH MTA Study. (undated, a). Information for parents.  Obtained from http://pioria.cpmc.columbia.edu/mta/parent.html.  on March 1, 1999.
 NIMH MTA Study. (undated, b).  Teacher information.  Obtained from http://pioria.cpmc.columbia.edu/mta/teacher.html.  on March 1, 1999.
 NYSPI Sponsored Research. (last update, 1998, December 21).  Research foundation for Mental Hygiene, Inc., Psychiatric Institute Division.  Obtained at http://www.nyspi.cpmc.columbia.educ/nyspi/rfinhgmt.Rf_spon.htm on March 1, 1999.



And Later, how did these kids do?

"...despite treatment, the children with ADHD showed significantly
higher-than-normal rates of delinquency (27.1 percent vs. 7.4 percent)
and substance use (17.4 percent vs. 7.8 percent) after three years.
Earlier evidence of lower substance use rates among children who had
received intensive behavioral therapy had lessened by the third year
."


http://www.nimh.nih.gov/press/mtafollowup.cfm

Improvement Following ADHD Treatment Sustained in Most Children
But Linked Problems Persist Into Adolescence - Major Follow-up Study

July 20, 2007
Contact: Jules Asher, NIMH Press Office
301-443-4536  NIMHpress@nih.gov

Most children treated in a variety of ways for attention deficit
hyperactivity disorder (ADHD) showed sustained improvement after three
years in a major follow-up study funded by the National Institutes of
Health's (NIH) National Institute of Mental Health (NIMH). Yet
increased risk for behavioral problems, including delinquency and
substance use, remained higher than normal.

The study followed-up children who had participated in the Multimodal
Treatment Study of Children with Attention Deficit Hyperactivity
Disorder (MTA).

Initial advantages of medication management alone or in combination
with behavioral treatment over purely behavioral or routine community
care waned in the years after 14 months of controlled treatment ended.

However, Peter Jensen, M.D., Columbia University, and colleagues
emphasized that "it would be incorrect to conclude from these results
that treatment makes no difference or is not worth pursuing."

Their report is among four on the outcome of the MTA study published
in the August, 2007 Journal of the American Academy of Child and
Adolescent Psychiatry (JAACAP).

"We were struck by the remarkable improvement in symptoms and
functioning across all treatment groups," explained Jensen.

After three years, 45-71 percent of the youth in the original
treatment groups were taking medication. However, continuing
medication treatment was no longer associated with better outcomes by
the third year.


"Our results suggest that medication can make a long-term difference
for some children if it's continued with optimal intensity, and not
started or added too late in a child's clinical course," added Jensen.

For the followup study, a multi-site research team evaluated, at ages
10-13, 485 children from the original MTA study, the first major
randomized trial comparing different treatments for ADHD, published in
l999. That study found that intensive medication management alone or
in combination with behavioral therapy produced better outcomes than
just behavioral therapy or usual community care.

Ratings from families and teachers favored the combination treatment,
which allowed for somewhat lower medication doses. Also, the careful
management of medication by MTA physicians produced better outcomes
than medication provided through usual community care sources.

After the 14 months of assigned treatments ended, families were free
to choose from treatments available in their communities.

To understand why the initial advantage of medication wore off, the
researchers examined medication use patterns that emerged after formal
treatment in the study ended. They found that children who had been
assigned to intensive behavioral treatment were more likely to begin
taking medication, while those who had been taking medication were
more likely to stop. For example, among children originally in the
behavioral treatment group, the incidence of high medication use
increased from 14 to 45 percent.

In a secondary analysis of the data that searched for possible
explanations for the findings, in the same issue of the JAACAP,
researchers led by James Swanson, Ph.D., University of California at
Irvine, reported finding substantial individual variability in
responses to medication. They identified three groups of children with
different patterns of response. One group, about a third of the
children, showed a gradual, moderate improvement; a second group,
about half of the children, showed larger initial improvement, which
was sustained through the third year; a third group, about 14 percent
of the children, responded well initially, but then deteriorated as
symptoms returned during the second and third years. Swanson and
colleagues suggested "trial withdrawals" for some children to
determine if they still need to take medications.

Another report by Swanson and colleagues in the same issue of the
JAACAP confirmed an earlier finding from the MTA study that taking
medication slowed growth. A group of 65 children with ADHD who had
never taken medication grew somewhat larger — about three-fourths of
an inch and 6 pounds more, on average — than a group of 88 peers who
stayed on medication over the three years. Growth rates normalized for
the children on medication by the third year, but they had not made up
for the earlier slowing in growth.

In a fourth article, Brooke Molina, Ph.D., University of Pittsburgh,
and colleagues reported that, despite treatment, the children with
ADHD showed significantly higher-than-normal rates of delinquency
(27.1 percent vs. 7.4 percent) and substance use (17.4 percent vs. 7.8
percent) after three years. Earlier evidence of lower substance use
rates among children who had received intensive behavioral therapy had
lessened by the third year. "These findings underscore the point that
ADHD treatment for one year does not prevent serious problems from
emerging later," noted Molina.

The follow-up of the MTA sample will continue as the participating
children go through adolescence and enter adulthood.

The following researchers participated in the studies:

Three-year Follow-up of the NIMH MTA Study. Peter S. Jensen, L. Eugene
Arnold, James M. Swanson, Benedetto Vitiello, Howard B. Abikoff,
Laurence L. Greenhill, Lily Hechtman, Stephen P. Hinshaw, William E.
Pelham, Karen C. Wells, C. Keith Conners, Glen R. Elliott, Jeffery N.
Epstein, Betsy Hoza, John S. March, Brooke S.G. Molina, Jeffrey H.
Newcorn, Joanne B. Severe, Timothy Wigal, Robert D. Gibbons, Kwan Hur

Secondary Evaluations of MTA 36-Month Outcomes: Propensity Score and
Growth Mixture Model Analyses. James M. Swanson, Stephen P. Hinshaw,
L. Eugene Arnold, Robert D. Gibbons, Sue Marcus, Kwan Hur, Peter S.
Jensen, Benedetto Vitiello, Howard B. Abikoff, Laurence L. Greenhill,
Lily Hechtman, William E. Pelham, Karen C. Wells, C. Keith Conners,
John S. March, Glen R. Elliott, Jeffery N. Epstein, Kimberly Hoagwood,
Betsy Hoza, Brooke S.G. Molina, Jeffrey H. Newcorn, Joanne B. Severe,
Timothy Wigal, and the MTA Cooperative Group

Effects of Stimulant Medication on Growth Rates Across 3 Years in the
MTA Follow-up. James M. Swanson, Glen R. Elliott, Laurence L.
Greenhill, Timothy Wigal, L. Eugene Arnold, Benedetto Vitiello, Lily
Hechtman, Jeffery Epstein, William E. Pelham, Howard B. Abikoff,
Jeffrey H. Newcorn, Brooke S.G. Molina, Stephen P. Hinshaw, Karen
C.Wells, Betsy Hoza, Peter S. Jensen, Robert D. Gibbons, Kwan Hur,
Annamarie Stehli, Mark Davies, John S. March, C. Keith Conners, Mark
Caron, Nora D. Volkow, for the MTA Collaborative Group

Delinquent Behavior and Emerging Substance Use in the MTA at
36-Months: Prevalence, Course, and Treatment Effects. Brooke S. G.
Molina, Kate Flory, Stephen P. Hinshaw, Andrew R. Greiner, L. Eugene
Arnold, James M. Swanson, Lily Hechtman, Peter S. Jensen, Benedetto
Vitiello, Betsy Hoza, William E. Pelham, Glen R. Elliott, Karen C.
Wells, Howard B. Abikoff, Robert D. Gibbons, Sue Marcus, C. Keith
Conners, Jeffery N. Epstein, Laurence L. Greenhill, John S. March,
Jeffrey H. Newcorn, Joanne B. Severe, Timothy Wigal, and the MTA
Cooperative Group. The Office of Special Education Programs of the
U.S. Department of Education, the Office of Juvenile Justice and
Delinquency Prevention of the Justice Department, and the National
Institute on Drug Abuse (NIDA) also participated in funding this
study.

The National Institute of Mental Health (NIMH) mission is to reduce
the burden of mental and behavioral disorders through research on
mind, brain, and behavior. More information is available at the NIMH
website.

The National Institutes of Health (NIH) - The Nation's Medical
Research Agency - includes 27 Institutes and Centers and is a
component of the U.S. Department of Health and Human Services. It is
the primary federal agency for conducting and supporting basic,
clinical and translational medical research, and it investigates the
causes, treatments, and cures for both common and rare diseases. For
more information about NIH and its programs, visit the NIH website.




AND WHAT ABOUT THE GROWTH SUPPRESSION?

remember, the MTA study involved 579 children between the ages of 7 and 10:

 

 

                            Growth Rate Reduction on Stimulants - MTA Study

 

            Year 1                         Year 2                                                                         Growth Suppression Under DrugTherapy

                                                                                               

            -0.90 cm per year        -1.04 cm per year                    ~ 1 cm (1/2 inch) per year

            -2.55 kg per year         -1.22 kg per year                     ~ 1.25 kg (3 lb) per year

 

Similar effects have been detected in even younger children.  In a second federally sponsored experiment (the Preschool ADHD Treatment Study, or PATS), researchers from the National Institute of Mental Health and outside academic centers examined the effects of a specific stimulant (methylphenidate) upon 140 previously unmedicated children under the age of five. 

 

Following a ten-month period of treatment with methylphenidate, preschoolers experienced a 20% reduction in height gain (based upon an expected gain of  6.79 cm/year) and a 55% reduction in weight gain (based upon an expected gain of 2.39 kg/year):

 

 

                        Growth Rate Reduction on Stimulants – PATS

 

                        growth rate deficit      change in *percentile points    change in **z-units

           

height              - 1.38 cm/year (0.54”)        - 7.53 pts per year              - 0.26 per year          

weight             - 1.32 kg/year  (2.9 lbs)      -13.18 pts per year             - 0.49 per year

 

*percentile points - changes in growth patterns as they appear on a standard growth chart.  Healthy growth is associated with very little variation in percentile points, as a child will generally find a steady line of growth and follow it.   Children growing along the 50th

percentile will be taller or shorter than 50% of their peers.  Children growing along the 10th percentile will be taller than 10%, but shorter than 90%, etc.  

 

**z-units – a statistical method of reporting data in terms of the distribution around the mean (average score).   A z-unit of 1 refers to a measurement which is exactly 1 standard deviation greater than the mean.   Z-scores are used in research in order to permit comparisons between different populations in various studies.

 

 

Back to Phelps:

turns out that although there is limited evidence for growth suppression (of skeleton) due to growth hormone, IGF, and/or thyroid hormone disruption,  there is even better data emerging for the negative effects of dopamine and serotonin disruption.....

 

[of course, there are MANY growth factors that influence skeletal development.............neurotransmitters are increasingly being recharacterized as paracrine substances, so they are not "just brain chemicals" as most physicians have been accustomed to viewing them]

 

kids grow in spurts ......growth rate speeds up and slows down many times between latency and puberty....then, there is a pubertal growth accleration...................it is quite likely that Michael Phelps attained his 6'4" status because of the fact that he did not continue stimulants indefinitely.................

 

it is also likely that the growth spurt in puberty enables kids to regain a normal growth RATE ... it is growth RATE which is suppressed by the earlier periods of medication;..............

 

interestingly, we do not know when Phelps' "double jointedness" emerged.................i think it is interesting to contemplate whether or not the use of stimulants in latency age  might have affected chrondrocytes and cartilage development, but i know of no biological precedent for an "acquired"  double jointedness...

 

in any event,  the key point is that I, personally, do not believe it is possible to compromise skeletal growth without simultaneously compromising brain development, when the growth delay is due to an exogenous chemical........dopamine disruption is dopamine disruption.

 

there are both negative developmental effects of stimulants in pre-pubertal (and post-pubertal) children, and negative TOXIC (cell killing) effects.

 

one can damage the brain in both ways

 

the skeleton appears to recover once the stimulants are stopped but the same cannot always be said for the brain (however, the latest research shows that most psychiatric drugs cause osteoporosis......i suspect that this includes the stimulants when they are consumed by older adults)........




SO WHAT IF WE DON'T USE MEDICATIONS?

Does medication make a difference in the long run for kids suffering from the disorder? For some, new research suggests it doesn't.  By Melissa Healy, Los Angeles Times Staff Writer, January 28, 2008

Doctors and parents have long been left to guess at which children with a diagnosis of attention-deficit hyperactivity disorder, or ADHD, will go on to become adults with significant attention problems, how well they will navigate the challenges of adulthood and whether early recognition of -- and medication for -- their condition will make any difference in the trajectory of their lives.

Now a series of studies following 457 Finnish children from birth to ages 16 to 18 offers a glimpse of how the primary symptoms of ADHD typically evolve. At the same time, the studies raise provocative questions about the long-term effect of treating those symptoms with medication.

 The studies focus on a subset of 188 Finnish teens considered to have "probable or definite ADHD" that will follow them into adulthood and 103 kids with conduct disorder -- behavior issues that fall short of an ADHD diagnosis but put kids at higher risk for similar problems. Those teens were compared with a group of Finnish teens with no ADHD diagnosis.

Researchers found it is the can't-sit-still kids -- the stereotype of the "ADHD generation" -- who are most likely to mature out of the disease. Among those with persistent ADHD, they also found, half have problems with cognitive skills that are key to success in adulthood, but half have no such deficits.

And when researchers compare the findings from Finland to studies of Americans with ADHD, an even more intriguing discovery emerges: By the time they're in their late teens, those who receive drugs for attention problems seem to fare about the same as those who do not.

That is sure to fuel a simmering debate over the extent to which American kids with ADHD receive medication, often with little other support. In Finland, medication for ADHD is extremely rare.

"This begs the question: Are current treatments really leading to improved outcome over time?' " wrote UCLA neuropsychologist Susan L. Smalley and co-author Dr. Marjo-Riitta Järvelin in a special section of December's Journal of the American Academy of Child & Adolescent Psychiatry. Smalley co-directs UCLA's Center for Neurobehavioral Genetics. Järvelin is a professor of public health and of medicine at Imperial College School of Medicine in London and University of Oulu, Finland, respectively.

UCLA neuroscientist Robert Bilder, who was not involved in the Finnish research, said the studies suggest that ADHD might best be treated, in some kids, by shoring up weaknesses in underlying cognitive skills rather than by focusing exclusively on behavioral symptoms that can change with age.

HOW DO WE HELP AT APHS...Here is one Evidence Based Program for the child, parents, and teachers!

The following article was published in a Best Practices journal in the spring of 2000.

The Nurtured Heart Approach

Howard N. Glasser, Executive
Director, The Children's Success Foundation

The Nurtured Heart Approach has been practiced at Tucson's Center for the Difficult Child (CDC) between 1994 and 2001. It is a strategic family systems approach designed to turn the challenging child around to a new pattern of success. The approach has also been found to produce substantial success in helping the average child flourish at higher-than-expected levels of functioning.

The approach is now used in hundreds of classrooms nationally, and its strategies have been adopted with substantial success as the school-wide discipline plan in several Tucson schools.

The Nurtured Heart Approach teaches significant adults how to strongly energize the child's experiences of success while not accidentally energizing his or her experiences of failure. Most approaches, because they were designed for the average child, get stretched beyond their capacity when applied to challenging children. Traditional approaches for parenting and teaching can easily backfire with challenging children: they inadvertently reward children by providing more energy, involvement and animation when things are going wrong. Challenging children wind up being very confused because they perceive a high level of incentive for pushing the limits and for negative behaviors and little incentive to make successful choices. Often, the harder adults try applying these normal methods, the worse the situation becomes, despite the best of intentions.

Since The Nurtured Heart Approach was first introduced at CDC in 1994, a number of studies have been undertaken and several positive outcomes have emerged.

School Outcomes:

Tolson Elementary School in Tucson Arizona, a Title I school of over 500 children (80% free or reduced lunch) has shown remarkable progress since beginning a school-wide Nurtured heart Approach intervention in 1999. Prior to that many children were referred for ADHD assessments and were put on medications. They had eight times the normal number of school suspensions per year as other schools in the district and teacher attrition was well over 50% per year. Since that time there has only been one child suspended, no children at all diagnosed as ADHD and no new children on medications. Teacher attrition has dropped to less than 5% and special education utilization has dropped from 15% to 5%. Best of all, the school has gone from the worst in district as measured by standardized test scores to having dramatic and continuing positive progress. This data is in keeping with other informal observations noted when this approach has been applied in other school-wide applications.

Many HeadStart programs around the county use The Nurtured Heart Approach. The city of Tucson adopted the approach in the year 1999 and has used it successfully every since. The data they have collected for the 3,000 underprivileged children they serve each year confirms that in this time period they too have not needed to send a child for a diagnostic assessment or medication services at all. They use the approach class-wide and in addition to feeling that the approach helps all the children to flourish it has helped them to help the at-risk children to do well within the classroom setting without needing outside services.

Both Tolson Elementary and Tucson HeadStart report a strong increase in their ability to positively impact the parent communities they serve.

Recidivism:

The most recently published findings are from the 1999 "Year in Review" study conducted by Pima County Juvenile Court in relation to the Pre-Adolescent Diversion Project (PADP) of Tucson's Child and Family Resources. The project's parenting component and several other aspects of the program are based on The Nurtured Heart Approach. The project is a 16-hour workshop series over 4 weeks for first offending youth and their families.

According to Pima County Juvenile Court researchers, first offenders referred to other Juvenile Court programs have shown a 32% rate of recidivism, whereas the rate of re-offense for those youth who have completed PADP with their families is only 18%. This represents a 45% rate of improvement over other diversionary programs. Typically, youth who re-offend do so at escalating rates of intensity, committing bigger crimes and more often. The graduates of PADP who did re-offend committed lesser offenses. The statistical significance of the 18% rate of recidivism is .00001. This occurrence could not have happened by chance alone. Therefore, the strategies and approach of the Pre-Adolescent Diversion Project have been shown to produce noticeable improvement.

Medications:

Another indicator of The Nurtured Heart Approach's effectiveness may be related to informal research regarding the use of medications among CDC clients.

Although many children referred to CDC are already on medication, CDC has scrutinized the records of children who are referred to the agency with no prior evaluation and therefore are not taking medications at the time of intake.

Upon close examination of the initial assessments of those already on medications and those not on medications, no difference is discernible. Those who are referred who are not on medications typically have very much the same symptoms and levels of severity as those who are already on medications at the time of intake. Most frequently those symptoms match the profiles of Attention Deficit/Hyperactivity Disorder (ADHD) and Oppositional-Defiant Disorder, with problems of aggression, compliance, impulsivity, distractibility, and a preponderance of school related issues.

National statistics show that of all children going to a primary care physician or a child psychiatrist for an initial assessment with these kinds of symptoms, 75% are prescribed medications at the time of that evaluation. It can therefore be assumed, given the kinds of symptoms and the level of severity of the children referred to CDC, that approximately 75% of these children would be put on medications if CDC's very first step were referral to a physician for an evaluation.

During a 10-month period in 1998, CDC worked with 211 children. Of these, 51 were already on medications prior to referral to CDC. Of the 160 children who were not already on medications, only eight were subsequently referred for psychiatric evaluations and only four were actually prescribed medications subsequent to the evaluation. This represents less than a 3% rate of utilization of medications. Perhaps just as interesting is that nine of the 51 on medications were successfully transitioned off medications during this time frame.

Overall improvements:

A separate on-going study conducted collaboratively by the Community Partnership for Southern Arizona (CPSA) research department since late 1996 involves pre- and post-treatment administration of the Connor's Parent Rating Scale with all CDC clients. Preliminary assessment of the data indicates excellent results in terms of efficacy of treatment. All scales of the Connors show improvement at the .01 level of significance and five of the six scales show improvements beyond four standard deviations. The study further confirms that, in general, the presenting symptoms of CDC clients at intake show a high degree of severity while the outcomes show children well within the mid-range of normative behaviors. Further analysis will be forthcoming.

Utilization of high-level services:

Considering the consistently high severity of CDC clients at intake, a fairly remarkable outcome has emerged over the years in relation to the number of CDC children who eventually needed high level and costly interventions such as out-of-home placements. Since 1994, only 8 children have required higher levels of intervention. This is despite the fact that many of the children referred to CDC over the years had one or more mental health related hospitalizations prior to referral to CDC.

The Nurtured Heart Approach also has been called upon numerous times to help transition children from high-level interventions to normal family life and regular levels of treatment. The related preventive request--to take on a child headed for a high-level intervention as a way of re-stabilizing the child--is also a routine facet of the capacities of this approach.

Re-utilization:

In a study of 808 of CDC cases from November 1994 through October 1998, only 28 children needed to have their cases re-opened and, in most of these instances, subsequent treatment was very brief and successful. Most of these families needed only a little inspiration or clarification on how to get back on track with the approach. The rate of re-utilization is less than 3.5%.

Cost/efficacy:

Many consumers do not qualify for the public mental health system and find the cost of on-going private treatment prohibitive. The Nurtured Heart Approach, typically taught for 8-12 total hours over a four-week period, is very well-suited to multi-family group scenarios, thus allowing families without insurance benefits to have an alternative form of affordable treatment.

In 1996, Dr. Shirli Ward researched The Nurtured Heart Approach for her doctoral dissertation. Comparison of a Nurtured Heart Approach large group format (over 30 parents in one group training) showed levels of success similar to that produced by therapeutic work with individual families. Dr. Ward pointed out that other prominent parent training programs were limited in size to a maximum of eight families, making The Nurtured Heart Approach considerably more time and cost effective.

The study also found that it was not necessary for both parents to participate in the training to achieve beneficial results. In one component of the study, only mothers were involved in the training and their children were not directly involved in the treatment. The mothers were able to become, in effect, the "therapists." The results reflected a high degree of satisfaction with the program in terms of improvements in family life and the progress their children made.

Dr. Ward further assessed the effect of the approach on child and parent functioning using the Devereaux Scale of Mental Disorders along with the Parent Stress Index, the Parenting Sense of Competence Scale, the Beck Depression Inventory, and the Forehand Satisfaction Survey.

Dr. Ward found that, relative to subjects in the comparison group, those involved in The Nurtured Heart Approach parent-training model demonstrated significant changes in functioning following treatment. Mothers reported significant (.01) improvements in their child's behavior related to the following: conduct, anxiety, communication, acute problems, and overall severity. In addition, in terms of their own well-being, mothers reported fewer depressive symptoms, decreased stress levels and increased parenting effectiveness and satisfaction following treatment.

These results were found to be consistent across the researched diagnostic categories of Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Conduct Disorder and Depressive Disorder as well as for children for whom treatment was sought for general noncompliance and Adjustment Disorder.

In 1994, Dr. Lorence Miller, also using the Devereaux Scale of Mental Disorders, found that a sample population of children in treatment at CDC had higher levels of severity at entry into treatment than the comparison groups of selected specific diagnoses used in the Devereaux groups own studies of criterion-related validity. The CDC sample population had more severe problems in all areas but attention. Dr. Miller's post-test results for both The Nurtured Heart Approach family treatment and large multi-family group treatment modalities were shown to have extremely significant effects toward normalized behaviors.

Training:

Perhaps one last measure of The Nurtured Heart Approach could be viewed in relation to the training of professionals. The approach is so readily transferred to other professional that they become fully competent in a relatively short period of time.

CDC accepted its first two interns, both Masters Degree students in the University of Phoenix Marriage and Family Program, in 1999. Within two months, both were so effective with families in treatment that they were comparable to senior therapists in both the results they produced and their own perceived level of competency. This year, five more interns have applied to CDC training program and are following suit in their level of confidence. CDC attributes a great deal of the success of the training to the inherent power of the model: The Nurtured Heart Approach.

 

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