Attention Research Update
November 2002
"Helping parents, professionals and educators
stay informed about new research on ADHD"
David
Rabiner, Ph.D. Senior Research
Scientist, Duke University
Support for this issue of Attention Research Update has been provided
by:
Landmark College
Landmark is the only accredited college in the country designed exclusively for students of average to superior intellectual potential who have ADHD or specific learning disabilities.
A national center for research and education, over the past two decades, Landmark College has served thousands of students with learning differences, providing them with learning, study, and other skills, while offering them a rigorous liberal arts education.
At Landmark College, success is the norm, not the exception. Our students learn what it's like to thrive. Please visit the Landmark College web site to learn more..
When a child is diagnosed with AD/HD, an important decision that parents confront is whether to include medication as part of their child's overall treatment plan. Although many factors are involved in this decision, medication treatment is frequently recommended because it currently has the most substantial research support as an effective treatment for AD/HD. By 1996, 161 randomized controlled trials involving thousands of individuals with AD/HD across a wide age range had been published, and improvements were reported to occur in between 65 and 75% of those receiving stimulant medication. Although many of these studies were short-term trials lasting fewer than 12 weeks, results from the Multimodal Treatment Study of AD/HD (i.e. MTA study) indicated that benefits of carefully conducted medication treatment persist over longer time periods, as positive outcomes were reported after children were followed for 14 months.
Although the benefits of medication treatment are well documented, results from carefully conducted research may overestimate its value to children treated in regular community settings. In the MTA study, children receiving medication treatment through the study - whether alone or in combination with intensive behavioral therapy - experienced greater reductions in AD/HD symptoms than children treated with medication by community physicians. For example, 68% of children receiving combined treatment (i.e. medication and behavior therapy) and 56% of children receiving medication treatment alone had ratings of AD/HD and ODD (i.e. oppositional defiant disorder) symptoms after 14 months that fell within the normal range. In contrast, only 25% of community treated children treated - two-thirds of whom received medication - showed normalized levels of symptoms. (You can read a review of this study here.) Approximately 90% of children receiving medication in the MTA study no longer met full diagnostic criteria for AD/HD. Results from a recent study of children with AD/HD treated with medication by community physicians, however, found that that almost 40% continued to meet full AD/HD diagnostic criteria. Finally, in another recent report, there was no indication that community-based treatment improved the educational outcomes for children AD/HD.
A reasonable conclusion to draw from this evidence is that although medication treatment can effectively manage AD/HD symptoms for many children, the benefits provided often fall short of what is possible. For this reason, it is important to understand why children treated in research studies often do better than children receiving the same medication in the community. This knowledge can help parents maximize the benefits of medication treatment for their child, should the decision to try medication be made in consultation with their child's health care provider. Thus, the focus of this article will be on guidelines for maximizing the benefits of medication treatment once this decision has been made, and not on considerations involved in this decision. Such decisions often involve a multitude of factors and are best made in consultation with an experienced health care professional.
Lessons from the MTA Study
What practices are likely to increase the gains associated with medication treatment? An examination of medication treatment procedures used in the MTA study provides valuable information on this question. Key elements of these procedures, and how they are likely to differ from what typical practice, are highlighted below.
* Children received an initial trial in which they were
tested on 3 different doses of stimulant medication and a
placebo. Parents and teachers completed standardized ratings of
children's behavior and side effects on the different doses to help
insure that medication provided a significant benefit (i.e. the child
did better on medication than on placebo) and to determine the optimal
starting dose for each child. Systematic monitoring of children's
response to a full range of doses, although recommended in the
treatment guidelines recently published by the American Academy of
Pediatrics, may often be neglected in community practice setting.
As a result, many children are likely to start treatment on a
non-optimal dose.
* For those children for whom the initial stimulant was not
effective, further testing using other stimulants was initiated.
Thus, rather than giving up on stimulant medication if initial results
were disappointing, testing was continued using other medications, and
an effective medication was eventually found for the vast majority of
children. In community settings, it may be more common for
medication to be discontinued if initial results are not positive, or
to switch to another class of medication before trying other
stimulants.
* Once an effective medication was found, MTA treated
children received 3 doses per day to provide full day coverage.
Children treated in the community with medication received an average
of about 2 doses/day, and, on average, received a smaller total daily
dose. Because study treated children experienced greater
reductions in AD/HD symptoms, children receiving medication treatment
in community settings may often be maintained on doses that are not
sufficient to provide maximal benefit. (Note: The initial
stimulant used in the MTA study was methylphenidate, the generic form
of Ritalin. Since the MTA study was conducted, several longer
acting stimulants have become available - e.g. Concerta, Adderal-XR,
Metadate, Ritalin- LA. These medications may be preferable in
many instances because they eliminate the need for administration
during the school day, which often poses a variety of problems.)
* Once the initial medication and starting dose was determined,
ongoing treatment effectiveness was monitored via monthly follow up
visits and phone contacts with children's teachers. In community
settings, ongoing treatment monitoring is typically far less intensive.
Translating these Lessons into Practice
Although there were other differences between study- and
community-treated children, those discussed above certainly
seem to be among the most important. Because
the procedures used in the MTA study resulted in better child outcomes,
it is important that parents try to make sure that their child's
treatment is consistent with these procedures. Although the
specifics of some MTA medication treatment procedures would be
difficult to replicate exactly in community settings (e.g. the initial
placebo-controlled trial involving daily dose changes and daily teacher
and parent behavior ratings), the principals underlying these
procedures are not. In fact, guidelines for improving AD/HD
medication treatment in community settings that draw on MTA results
have been published recently by the American Academy of
Pediatrics, the American Academy of Child and Adolescent
Psychiatry, and the Texas
Consensus Conference Panel. Key elements of these guidelines
are synthesized below.
Guideline #1- When initiating medication treatment, be sure that your child is tested on a full range of doses.
The optimum stimulant dosages for a child are not weight dependent
and it is not possible to predict in advance what the best dose -- or
most effective stimulant -- will be for an individual child.
Clinicians should begin with a low dose and gradually increase it
across the full range of recommended dosages to determine the best fit
for each child. The critical reason for this is that the first dose to
yield beneficial effects may not be the best dose to optimize a child's
functioning, and unless a child is tried on a full range of doses, it
is quite possible that the optimal starting dose will be missed.
Guideline # 2 - Before medication treatment is implemented, parents should insist that a systematic procedure is in place to monitor the effectiveness of the different doses being tested.
Determining the benefits of medication treatment need to be far more
systematic than anecdotal reports from a teacher that the child seems
to be "doing better". Treatment guidelines recently published by
the American Academy of Child and Adolescent Psychiatry recommend that
standardized and validated behavior rating scales, along with
systematic procedures for evaluating side effects, be used to determine
whether medication was effective and to decide upon the optimal
starting dose. In addition to ratings of core AD/HD symptoms -
i.e. inattention and hyperactivity-impulsivity - it is important to
obtain information on the child's academic functioning, social
relations, and ability/willingness to follow rules at home and
school. This is important because effective treatment for AD/HD
should enhance children's functioning in these key areas in addition to
reducing core AD/HD symptoms. And, even when medication is
effective in reducing core symptoms, residual difficulties in important
functional areas can still remain. When this occurs, additional
treatments that specifically target these residual difficulties need to
be incorporated. Without a procedure for assessing outcomes of
medication treatment in multiple domains, the information needed to
make these important treatment decisions will not be available.
Guideline #3 - If the initial stimulant medication tested is not effective, alternative stimulants should be tried before giving up on medication, trying a different class of medication, or combining other medications with a stimulant.
As noted in AAP treatment guidelines, children may respond favorably to one stimulant, but not another. And, which stimulant or dose will be most effective for a particular child is currently impossible to predict. For this reason, the guidelines recommend that 2-3 stimulant medications be tested across a full range of doses before non-stimulant medications be considered.
Results from the MTA study suggest that when this procedure is followed, the vast majority of children with AD/HD will obtain effective AD/HD symptom management with one of the stimulants, and using non-stimulant medications (e.g. clonodine, antidepressants, etc.) or multiple medications will rarely be necessary. In fact, less than 2% of children receiving medication treatment in the MTA study were on non-stimulant medications at the end of the study. Many children treated in community settings, however, are prescribed non-stimulant drugs or receive several medications simultaneously. For example, a recent report indicates that almost of 25% of children who receive stimulant treatment are also prescribed a second medication. This is concerning because research supporting the safety and efficacy of combined pharmacotherapy for children with AD/HD is sparse.
In the MTA study, there were certainly a higher percentage of
community treated children who received non-stimulants and/or multiple
medications. And, because outcomes for community treated children
were poorer, there is little indication that this is generally helpful
or necessary. Although there may be specific situations where
non-stimulants or multiple medications are, these practices seem to be
outpacing any available research support, and parents who receive such
recommendations for their child should proceed cautiously.
Guideline #4 - After medication treatment has been initiated, it is critically important to monitor its ongoing effectiveness so that any necessary treatment adjustments can be made.
The importance of carefully and systematically monitoring the ongoing effectiveness of medication treatment for AD/HD cannot be overestimated. In many instances, although a child's symptoms may be managed well as treatment begins, this can change significantly over time. In the absence of a careful procedure for monitoring a child's ongoing functioning, treatment adjustments necessary to maintain optimal symptom management may not occur and poorer outcomes are likely to result.
The importance of carefully monitoring the ongoing effectiveness of
medication treatment was highlighted in a recent report from
the MTA study. As discussed above, medication treatment in
the MTA study began with a careful procedure to determine the optimal
starting dose for each child. Monthly follow up visits, including
gathering direct information about the child's functioning from his/her
teacher, were then used to determine whether this dose continued to be
effective, or whether adjustment to the child's medication treatment
was required.
* One might think that because such a careful procedure to determine the optimal medication and dose for each child was employed, that adjustments would be relatively rare. As indicated below, this was definitely not the case.
* Only 17% continued on the same medication and dosage throughout the entire 13-month maintenance period. The remaining children all experienced at least one change in drug or dosage during this period.
* Three months into the maintenance period, 56% of children had already had their medication or dosage changed. The average amount of time to the first dose change was 4-5 months. Across the entire maintenance period, the average number of changes required for each child was just over 2, but some children required as many as 10 medication adjustments. Of the total medication changes made, 62% involved increasing the dosage of the current medication, 31% involved decreasing dosage, and only 7% involved changing medications entirely.
As these results illustrate, effective medication treatment for AD/HD goes far beyond finding a medication and dose that provides initial benefits and simply continuing that treatment uncritically over time. Even when this initial treatment is determined in the most careful manner possible, it is likely that adjustments will be required to maximize treatment benefits over time. Unfortunately, this may rarely occur in community treatment. For example, children who received community care in the MTA study averaged just over 2 follow up visits per year, rather than the monthly visits provided for study treated children. And, it is unlikely that direct feedback from teachers was routinely obtained. This difference in ongoing treatment monitoring, and the adjustments to children's treatment that were made as a result, may be the single most important reason that MTA treated children had superior outcomes.
Without careful monitoring of ongoing treatment effectiveness, information needed to determine when treatment adjustments may be necessary will be lacking, and the likelihood that medication treatment will provide the maximal benefits will be reduced. (Note: Careful, ongoing treatment monitoring is not just important for medication treatment, but for whatever treatment(s) a child is receiving.) As a result, the child may receive sub-optimal medication treatment over an extended period, and this can adversely impact functioning in a variety of areas.
Parents can minimize this possibility for their child by insisting
that there be a plan to monitor the ongoing effectiveness of their
child's treatment that is implemented consistently. This
monitoring plan should include attention to both core AD/HD symptoms as
well as key functional outcomes (e.g. academic performance, peer
relations, following class rules), and physicians should be receiving
this information from both parents and teachers. I have developed
a relatively simple monitoring system that provides one example of how
to obtain and interpret this important information from teachers.
You can request this for free by visiting www.helpforadd.com/monitoring.htm
Summary
It is important to emphasize that the guidelines presented above are based on current research regarding best practices for medication treatment. As new research and new medications become available, best practice procedures may change accordingly. For example, the first non-stimulant medication specifically approved for treating AD/HD is expected to become available shortly, and research on this medication may result in its being regarded as a viable alternative to stimulants as a first line treatment. Regardless of what new medications become available, the recommendation pertaining to ongoing and systematic treatment monitoring should remain critical.
As noted above, the guidelines synthesized above have all been
published relatively recently, and one hopes that physicians will be
incorporating these recommendations into their regular practice
patterns. In particular, because primary care physicians treat
the vast majority of children with AD/HD, guidelines from the AAP have
the potential to significantly enhance the quality of care that many
children receive. Because treatment guidelines may not be adopted
quickly, however, in many instances it will be up to parents to make
sure that their child's treatment is consistent with current best
practice guidelines. I hope this article has provided information
that can assist parents in this critically important task.
Thanks again to Landmark College for
supporting this issue of Attention Research Update
(c) 2002 David Rabiner, Ph.D.
Information presented in Attention Research Update is for informational
purposes only, and is not a substitute for professional medical
advice. Although newsletter sponsors offer products and services
that I believe will be of interest to subscribers, sponsorship of
Attention Research Update does not constitute a specific endorsement or
guarantee of any company's product or services.