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New
Outcome Reports from the MTA (multi-modal treatment study of children with
ADD) Study of Medication Treatment for ADHD: The Importance of Ongoing
Monitoring. |
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This study is the
largest and most comprehensive treatment study of ADHD ever conducted,
involving 579 children between the ages of 7 and 9, each diagnosed with the
combined subtype of ADHD (i.e. these children had both inattentive and
hyperactive-impulsive symptoms). The study took place at 6 different sites
around the country. Children
participating in the MTA study were randomly assigned to one of 4 different
treatment conditions: combined treatment - a combination of carefully
administered medication treatment and intensive behavioral intervention;
medication management only; behavioral treatment only; and community care
(i.e. these children received treatment as usual in their communities.) Fourteen months after treatment began, the
children were assessed on a variety of different outcome measures covering a
variety of domains of functioning, including primary ADHD symptoms,
oppositional behavior, parent-child relations, peer relations, self-esteem,
anxiety/symptoms of emotional distress, and academic achievement. As
is typical of a study of this size, the initial results were complex, but can
be reasonably summarized. First, children in all 4 groups were doing better
at the end of the study than they were when treatment began. Second, on some outcomes, combined
treatment and medication management alone were superior to behavioral treatment
or community care. Finally, no
statistically significant differences were found between combined treatment
and medication management on any of the 19 individual outcomes examined
(although there was some indication that children receiving combined treatment
fared somewhat better). For a
comprehensive review of this initial set of findings, including a careful
description of the different treatments provided in this study, click here. Reviewing this extensive summary of the
initial MTA publication will be helpful in considering the information that
follows. The
absence of significant differences between the combined and medication
management treatments has been widely interpreted to indicate that behavioral
interventions do not provide any incremental benefit to well conducted
medication treatment. The MTA
researchers themselves, however, never made this conclusion. In fact, two
papers published in the February 2001 issue of the Journal of the In
the first paper -- Multimodal treatment of ADHD in the MTA: An alternative
outcome analysis (Conners et al., JAACAP, 40, 159-167) – the authors take a different
approach to examining treatment outcome than that used in the initial
publication. Rather than examine each
outcome measure separately -- which was done initially to determine whether
response to the 4 different treatments varied for specific outcomes -- the
authors of this paper created a single composite outcome measure by averaging
children scores on the individual measures.
This composite measure can be thought of as an indicator of how each
child was doing in general, across multiple domains of functioning. Although this approach eliminates the
possibility of comparing treatment outcomes in individual domains, comparing
the composite outcome scores for children in the 4 groups enables one to
obtain a more global perspective on the impact of the different treatments. The
second "re-analysis" of the treatment outcome data – Clinical
relevance of the primary findings of the MTA: Success rates based on severity
of ADHD and ODD symptoms at the end of treatment (Swanson et al., JAACAP, 40,
168-179) -- takes a slightly different approach. Rather than creating a composite outcome
score that reflects how children were doing in multiple domains of
functioning, the authors focus on parent and teacher ratings of core ADHD
symptoms and symptoms of ODD (Oppositional Defiant Disorder). And, the primary question examined is the
degree to which each treatment resulted in children displaying levels of ADHD
and ODD symptoms similar to what is typical for children without ADHD. When this was true, treatment was
considered to be successful. This
approach to examining the data (i.e. the percentage of children showing
non-deviant levels of symptoms at the end of treatment) is especially
instructive. Results The
results from analyses using the broad composite outcome described above are
informative, and modify (somewhat) conclusions drawn from the initial study
results. The authors report that, when
this composite was used to measure outcome, children receiving combined treatment
did significantly better than children in any other group. They did much better than the children who
received community care or behavioral treatment alone, and modestly better
than children whose treatment was restricted to careful medication
management. This latter result differs
from previously published findings in which researchers did not find
statistically significant advantages for combined treatment relative to
medication management for individual outcomes. When medication management alone was
compared to behavioral treatment alone, medication treatment demonstrated a
modest superiority. Results
from the second paper help put these results in a somewhat clearer
perspective. Recall that in this
paper, the authors focused on the percentage of children in each group who
had average parent and teacher ratings of ADHD and ODD symptoms at the end of
treatment -- i.e. symptom ratings were similar to those of children without
ADHD. Results from this analysis are
shown below. Combined
68% Medication 56% Behavioral 34% Community Care 25% As
the numbers indicate, over two-thirds of the children receiving combined
treatment had normalized scores after 14 months, compared to only 1 in 4
treated in the community. Normalized
outcomes were more likely when treatment included the careful medication
component (i.e. combined or medication) rather than intensive behavioral
interventions alone. Finally, combined
treatment alone was modestly superior to medication management. Specifically,
these data suggest that if children in the medication group had also received
the MTA behavioral interventions, a greater number would have been in the
=93normal=94 range at the 14-month outcome assessment. While
these results demonstrate the dramatic improvements in core ADHD symptoms
that are provided by effective treatment, it is also important to point out
that such improvement is not always the case.
Even when state-of-the-art medication and behavioral interventions
were combined, about one-third of children continued to show elevated levels
of ADHD/ODD symptoms 14 months later, relative to non-ADHD peers. Among those receiving the most carefully
conducted medication treatment available, over 40% continued to show elevated
levels of core ADHD symptoms. This
does not mean, of course, that these children were not benefiting from the
treatment. It does indicate, however, that many continued to experience
difficulties despite receiving the best possible care currently available. Summary And
Implications In
general, results from these two papers are consistent with the initial set of
published findings. As reported in the
initial outcome paper, children in all 4 groups showed significant
improvement. Children receiving careful medication treatment were doing
somewhat better than children whose treatments were limited to intensive
behavioral interventions. What is
evident here that was not initially reported, however, is that adding
behavioral interventions to careful medication management yields
significantly better outcomes when a composite outcome measure is used (i.e.
study 1 above) or when one considers the likelihood of normalized scores on
core ADHD/ODD symptoms (i.e. study 2).
Thus, the benefits of multi-modal treatment for ADHD are more clearly
supported by these results. (Note: It
is important to remember that participants in the MTA study were restricted
to those with the combined subtype of ADHD and included no children with inattentive
symptoms only. Thus, these results do
not inform us about the efficacy of the different treatments for children
with the inattentive subtype.) In
translating these findings to the issues faced by individual parents and
clinicians, several things are noteworthy.
First, parents need to be vigilant about trying to obtain treatment
for their child that is as close as possible to treatments used in the MTA
study. In regards to medication, this
means a careful initial trial is necessary to determine the optimum dosage
and medication for their child, followed by systematic monitoring to
determine how their child is doing and make adjustments as indicated. The
excellent results obtained by children treated with medication – either alone
or in combination with behavioral interventions points to the importance of
this careful approach. The
results also indicate that the addition of well-designed and carefully
implemented behavioral interventions could reasonably be expected to provide
some modest additional benefit. One caveat to mention here, however, is that
the behavioral interventions used in the MTA study would be difficult to duplicate
in most communities. Thus, it remains
unclear whether the intensity of behavioral interventions that are more
routinely available in this age of managed care would be similarly effective. Finally,
it should be noted that the treatments tested in the MTA study were limited
to medication and comprehensive behavioral treatment. As noted above, although these treatments
were clearly shown to be helpful, many participants continued to experience
important difficulty despite receiving state-of-the art care using these
approaches. This highlights the need
for continued efforts to develop other types of interventions. Parents should
be aware that promising results have been reported for a number of
alternative treatments including dietary interventions and neurofeedback.
Thus, should traditional approaches to treating ADHD (i.e. medication and/or
behavioral therapy) prove to be insufficient for a particular child, there
are other options that may prove fruitful. Medication Treatment
for ADHD: The Importance of Ongoing Monitoring Many
experts agree that there are at least 2 important problems with how
medication treatment for ADHD is provided to many children today. First, when medication treatment is
initiated, there is frequently no systematic procedure used to determine the
optimum dosage for each individual child. Rather
than collecting systematic ratings of children’s functioning from parents and
teachers on a range of different doses, physicians typically start a child on
the lowest possible dose, obtain only anecdotal feedback on the child’s
behavior, and elect to maintain the first dosage that seems to be
effective. In many cases, this is
unlikely to be the dosage that would provide the greatest improvement in a
child’s functioning. A
second important problem is, even when the maintenance dosage selected is
appropriate, there is often little ongoing effort made to systematically
monitor how a child is doing over time.
As a result, adjustments to
medication -- or to any other type of treatment the child is receiving -- are
not made, and symptoms that were being managed effectively at one time begin
to significantly interfere once again with a child’s functioning. The extent
to which ongoing monitoring of medication treatment is required is
highlighted by another paper to come out of the MTA study (Vitello, B. et
al., 2001. Methylphenidate dosage for children with ADHD over time under
controlled conditions: Lessons from the MTA. Journal of the In
the MTA study, 289 of the 7- to 9-year-old participants with ADHD were
assigned to receive medication treatment -- either alone or in combination
with intensive behavioral interventions.
To determine the best medication and dosage for these children, an
initial titration trial was conducted in which children’s functioning at
school and home was compared when receiving different doses of medication
(all children began with methylphenidate, the generic form of Ritalin, and a
full range of doses was tested for each child) or a placebo. By comparing parent and teacher ratings on
each dosage to the placebo, the researchers sought to determine the optimum
dosage for each child. When
no clear benefits were obtained for any dosage of methylphenidate tested, or
if adverse side effects were apparent, a similar trial was conducted with
another type of stimulant. Using this
strategy, a clearly optimal
medication regime was identified for approximately 90% of the participants. For the vast majority of children (79%),
good results were obtained on at least one of the methylphenidate doses
tested. For another 11% satisfactory
results were provided by the second stimulant used (dextroamphetamine, the
generic version of Dexedrine.) For
other children, the response to placebo was so robust that they were not
continued on medication after the titration procedure. After
medication treatment was implemented, careful monitoring was conducted of its
ongoing effectiveness over the next 13 months. Each month, information was obtained from
each child’s parents and teacher about key ADHD symptoms, functioning at home
and school, and possible side effects. If these reports indicated adequate
control of symptoms and no side effects, the child continued on the current
medication regime. If reports
indicated that symptoms had emerged that was causing impairment, or if
possible side effects were reported, the medication regime was changed. This could involve either increasing the
dosage to obtain better symptom management or lowering the dosage in an
effort to eliminate adverse effects.
Overall, this careful monitoring was intended to insure that no child
remained on less than optimal treatment. This was done even though an
extremely careful procedure had been used initially to determine the best
dosage for each child. This
procedure enabled the authors to examine several important issues related to
medication treatment for ADHD. First,
how does the optimal medication and dosage identified by a careful initial
titration trial compare to what is required over the course of treatment to
maintain optimal management of ADHD symptoms?
Second, how soon into treatment do medication adjustments typically
need to be made and how frequently do these tend to occur? Finally, does gender or the presence of
other conditions (i.e. Oppositional
Defiant Disorder, Conduct Disorder, or anxiety disorders) impact the need for
medication changes during ongoing treatment? Results How does initial medication
and dosage compare to what is required in ongoing treatment? Of
those children for whom an optimal medication treatment regime was identified
by the initial titration procedure, 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. Of
the children for whom methylphenidate was the medication on which maintenance
began, 12% needed to be switched to a different drug during maintenance in
order to promote optimum symptom management.
For the children who remained on methylphenidate, at the end of the
maintenance period, 29% were on the same dose, 41% were on a higher dose, and
18% were on a lower dose. Overall,
daily dosage required increased from an average of 30.5 mg/day at the
beginning of maintenance to an average of 34.4 mg/day by the end. (Note:
In the MTA study, children received 3 doses per day so these amounts
were divided across the 3 doses with the third dose being half the amount of
the first 2.) As you might expect,
those who began on a low dosage were likely to have it increased. Doses for
those starting on high doses (i.e. 35 mg/day) tended to decline. Eleven
children who had started on medication were no longer on medication at the
end of the study, presumably because side effects had emerged. Of the 32 placebo responders who did not
begin the maintenance period on any medication, all but 4 required medication
at some point during maintenance. How soon into
treatment do medication adjustments typically need to be made and how
frequently do these tend to occur? Three months into the maintenance period, 56%
of the children had already had their medication or dosage changed. The average amount of time to the first
dose change was between 4 and 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 types of medication. Does gender or the
presence of other conditions (i.e. oppositional defiant disorder (ODD),
conduct disorder (CD), or anxiety disorders) impact the need for medication
changes during ongoing treatment? About
20% of the children in the MTA study were girls. On average, girls remained on doses that
were approximately 20% lower on a mg/kg basis than boys. The time required to the first medication
change, or the number of changes required over the maintenance period did not
differ between boys and girls. In addition, the presence of other
disorders in addition to ADHD was not related to dosage at either end of
titration or maintenance, the time to first change, or the number of changes
required. Summary &
Implications The
results of this study make it clear that, even when extreme care is taken to
determine the optimal medication treatment regime for a child with ADHD,
changes in that regime are likely necessary to maximize the ongoing
management of symptoms. If one simply
continues to maintain a child on the initial regime that seems best, it is
very unlikely that the child’s symptoms will continue to be managed as
effectively as possible. The
importance of these results cannot be overstated. Without careful ongoing
monitoring, and adjustments to treatment made when indicated, most children
with ADHD are simply not going to do as well as they otherwise could. Although the focus of this study was on the
monitoring and adjustments required to medication treatment, it is important
to emphasize that careful monitoring is essential regardless of what type of
treatment, or combination of treatments, a child is receiving. One simply cannot assume that an initially
positive response to any treatment will be maintained consistently over
time. Instead, it is necessary to
carefully track how a child is doing, and make modifications to existing
treatment(s) when it becomes evident that symptoms are no longer being
managed as effectively as they need to be.
Although some children will continue to have problems regardless of
the modifications made (see article above), the likelihood of maximizing a
child’s ongoing success is certainly increased when this approach is
followed. |
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