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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5267_Библиотеки_им_академика_М_И_Перельмана
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where participants in a trial continue to receive medication as usual the medication
and/or protocol determining the medication regimen may not be uniform for all
participants, and if that is the case the trial could not be considered to be a true test of
a combined treatment strategy. It is also likely that adherence to medication would be
higher in a clinical trial context, with the consequence that the effects of medication
received as part of a clinical trial might be greater than the effects of continuing to
receive medication as usual. Hence, if medication modifies the response to psycho-
logical therapies it is possible that findings from true trials of combined treatment
might differ from findings from trials that include participants continuing with their
usual medication.
An additional analysis is reported that compares an intensive and comprehensive
combined intervention for ADHD with standard care that may include medication.
This analysis, based on data from the MTA study (MTA1999), was performed in order
to provide a comparison of what might currently be considered the best possible care
for ADHD with the more standard level of care provided in routine clinical practice.
Seven trials met the eligibility criteria set by the GDG, providing data on 544
participants. All were published in peer-reviewed journals between 1981 and 2004. In
addition, 20 studies were excluded from the analysis. The most common reasons for
exclusion were that the paper reported no appropriate data or the intervention was
inappropriate (further information about both included and excluded studies can be
found in Appendix 17).
11.2.4 Clinical evidence for combined treatment for ADHD versus
medication only
Evidence from important outcomes and overall quality of evidence are presented in
Table 33. The full evidence profiles and associated forest plots can be found in
Appendix 19 and Appendix 18, respectively.
Evidence from included trials of treatment for children with ADHD that compare
a combined intervention with receipt of the medication component of the intervention
alone indicates that there is little or no advantage of any type of combined interven-
tion over medication alone. Compared with medication there is no evidence of an
added effect of combined treatment on measures of core ADHD symptoms, emotional
state or self-efficacy.
The only evidence of a benefit of combined treatment over medication alone is for
parent ratings of conduct problems at the end of treatment, however, the benefits of
combined treatment on this outcome are only weak because the effect size is at the
lower end of the small effect size range and no benefit of combined treatment was
detected at later follow-up times.
The MTA study (MTA1999) is the largest trial of combination treatment for
ADHD and although the MTA data suggests that there was a small benefit from
combined treatment over medication management alone on parent ratings of conduct
problems at the end of treatment, the effect did not reach the magnitude of a small
effect size.
Combining and comparing psychological and pharmacological interventions
319
Combining and comparing psychological and pharmacological interventions
320
Combined intervention versus
stimulant medication
Total number of studies (number 7 (544)
of participants)
Study ID ABIKOFF2004A
BROWN1985
FIRESTONE1981
FIRESTONE1986
GITTELMAN-KLEIN1976
KLEIN1997
MTA1999
Age 5–12 years
Benefits (end of treatment)
Core ADHD symptoms at end of SMD 0.06 (0.24 to 0.12)
treatment (teacher-rated) Quality: High
K 6, N 482
Core ADHD symptoms at end of SMD 0.12 (0.31 to 0.07)
treatment (parent-rated) Quality: High
K 5, N 428
Conduct at end of treatment SMD 0.07 (0.26 to 0.11)
(teacher-rated) Quality: High
K 5, N 461
Conduct at end of treatment SMD 0.21 (0.41 to 0.01)
(parent-rated) Quality: High
K 3, N 378
Social skills at end of treatment SMD 0.03 (0.11 to 0.05)
(teacher-rated) Quality: High
K 3, N 333
Social skills at end of treatment SMD 0.14 (0.36 to 0.09)
(parent-rated) Quality: High
K 2, N 315
Social skills at end of treatment SMD 0.07 (0.54 to 0.41)
(child-rated) Quality: Moderate
K 1, N 68
Table 33: Study information and evidence summary table for trials
of combined interventions versus stimulant medication
Combined intervention versus
stimulant medication
Emotional outcomes at end of SMD 0.15 (0.09 to 0.39)
treatment (teacher-rated) Quality: High
K 2, N 265
Emotional outcomes at end of SMD 0.03 (0.25 to 0.19)
treatment (parent-rated) Quality: High
K 3, N 327
Emotional outcomes at end of SMD 0.28 (0.20 to 0.76)
treatment (child-rated) Quality: High
K 1, N 68
Self-efficacy at end of treatment SMD 0.02 (0.50 to 0.45)
(child-rated) Quality: Moderate
K 1, N 68
Benefits (3–6 months post-treatment)
Core ADHD symptoms at 3 months SMD 0.05 (0.93 to 0.82)
post-treatment (teacher-rated) Quality: Moderate
K 1, N 20
Core ADHD symptoms at 3 months SMD 0.25 (0.63 to 1.13)
post-treatment (parent-rated) Quality: Moderate
K 1, N 20
Benefits (7–12 months post-treatment)
Core ADHD symptoms at 7–9 months SMD 0.00 (0.59 to 0.59)
post-treatment (teacher-rated) Quality: Moderate
K 1, N 44
Core ADHD symptoms at 10 months SMD 0.06 (0.30 to 0.18)
post-treatment (parent- and Quality: High
teacher-rated composite score) K 1, N 264
Conduct at 7–9 months post-treatment SMD 0.00 (0.65 to 0.65)
(teacher-rated) Quality: Moderate
K 1, N 37
Conduct at 10 months post-treatment SMD 0.18 (0.42 to 0.06)
(parent- and teacher-rated Quality: High
composite score) K 1, N 264
Table 33: (Continued)
Continued
Combining and comparing psychological and pharmacological interventions
321
Combining and comparing psychological and pharmacological interventions
322
Combined intervention versus
stimulant medication
Social skills at 10 months post- SMD 0.21 (0.45 to 0.03)
treatment (parent- and teacher-rated Quality: High
composite score) K 1, N 264
Benefits (13–24 months post-treatment)
Core ADHD symptoms at 19–21 SMD 0.05 (0.90 to 0.81)
months post-treatment Quality: Moderate
(teacher-rated) K 1, N 21
Core ADHD symptoms at SMD 0.02 (0.27 to 0.23)
22 months post-treatment Quality: High
(parent- and teacher-rated K 1, N 242
composite score)
Conduct at 19–21 months post- SMD 0.23 (1.09 to 0.63)
treatment (teacher-rated) Quality: Moderate
K 1, N 21
Conduct at 22 months SMD 0.03 (0.27 to 0.20)
post-treatment (parent- and Quality: High
teacher-rated composite score) K 1, N 282
Social skills at 22 months post- SMD 0.04 (0.21 to 0.29)
treatment (parent- and teacher- Quality: High
rated composite score) K 1, N 242
Education outcomes at end of treatment
Reading at end of treatment SMD 0.04 (0.14 to 0.22)
Quality: High
K 6, N 478
Mathematics at end of treatment SMD 0.03 (0.22 to 0.15)
Quality: High
K 5, N 437
Education outcomes at 3–6 months post-treatment
Reading at 3 months post-treatment SMD 0.19 (0.69 to 1.07)
Quality: Moderate
K 1, N 20
Mathematics at 3 months SMD 0.52 (1.42 to 0.37)
post-treatment Quality: Moderate
K 1, N 20
Table 33: (Continued)
11.2.5 Clinical evidence for intensive combined treatment versus
usual care for children with ADHD
Comparison of the MTA combined intervention (medication management plus an
intensive multimodal psychological intervention for ADHD that involved interven-
tions with the child and parent, and a classroom intervention) with the MTA commu-
nity care group allows comparison of an intensive and comprehensive approach to
care with standard care (MTA1999) (see Table 34).
The MTA study of combined intervention provides an example of what might
be considered fully comprehensive care for ADHD; this is ongoing protocol-led
management of stimulant medication coupled with a complex psychological interven-
tion, that is, a multicomponent psychological intervention that continues for a year
or more, includes components directed at the child, the parent and the teacher/
classroom, and has intensive components (the summer camp in the case of the MTA
psychological intervention). The MTA trial participants in the community care group
received routine clinical care for ADHD; two-thirds of this group received medication for
Combined intervention versus
stimulant medication
Education outcomes at 7–12 months post-treatment
Reading at 10 months post-treatment SMD 0.02 (0.25 to 0.20)
Quality: High
K 2, N 303
Education outcomes at 13–24 months post-treatment
Reading at 19–22 months SMD 0.02 (0.26 to 0.23)
post-treatment Quality: High
K 2, N 261
Dichotomous outcomes
Leaving study for any reason Data not pooled:
ABIKOFF2004A: 18% (combination)
versus 29% (medication only)
BROWN1985: 0% versus 0%
FIRESTONE1986: 0% versus 0%
MTA1999: 2% versus 6%
K 1, N 429
Non-responders RR 0.63 (0.47 to 0.84)
Quality: High
K 4, N 426
Table 33: (Continued)
Combining and comparing psychological and pharmacological interventions
323
Combining and comparing psychological and pharmacological interventions
324
Combined intervention versus
community care
Total number of studies 1 (291)
(number of participants)
Study ID MTA1999
Age 7–9.9 years
Benefits (end of treatment)
Core ADHD symptoms at end of SMD 0.64 (0.89 to 0.39)
treatment (teacher-rated) Quality: High
K 1, N 263
Core ADHD symptoms at end of SMD 0.74 (0.99 to 0.49)
treatment (parent-rated) Quality: High
K 1, N 263
Conduct at end of treatment SMD 0.51 (0.76 to 0.26)
(teacher-rated) Quality: High
K 1, N 262
Conduct at end of treatment SMD 0.53 (0.78 to 0.29)
(parent-rated) Quality: High
K 1, N 263
Social skills at end of treatment SMD 0.14 (0.22 to 0.06)
(teacher-rated) Quality: High
K 1, N 213
Social skills at end of treatment SMD 0.27 (0.52 to 0.02)
(parent-rated) Quality: High
K 1, N 252
Emotional outcomes at end of SMD 0.02 (0.29 to 0.25)
treatment (teacher-rated) Quality: Moderate
K 1, N 213
Emotional outcomes at end of SMD 0.27 (0.02 to 0.52)
treatment (parent-rated) Quality: High
K 1, N 252
Table 34: Study information and evidence summary table for the MTA
trial of combined interventions versus community care
Combined intervention versus
community care
Benefits (7–12 months post-treatment)
Core ADHD symptoms at 10 months SMD 0.34 (0.58 to 0.10)
post-treatment (parent- and Quality: High
teacher-rated composite score) K 1, N 273
Conduct at 10 months post- SMD 0.31 (0.55 to 0.07)
treatment (parent- and teacher-rated Quality: High
composite score) K 1, N 273
Social skills at 10 months SMD 0.17 (0.41 to 0.06)
post-treatment (parent- and Quality: Moderate
teacher-rated composite score) K 1, N 273
Benefits (13–24 months post treatment)
Core ADHD symptoms at SMD 0.11 (0.36 to 0.15)
22 months post-treatment Quality: Moderate
(parent- and teacher-rated K 1, N 243
composite score)
Conduct at 22 months post- SMD 0.82 (1.08 to 0.56)
treatment (parent- and Quality: High
teacher-rated composite score) K 1, N 243
Social skills at 22 months post- SMD 0.04 (0.21 to 0.29)
treatment (parent- and Quality: High
teacher-rated composite score) K 1, N 243
Education outcomes at end of treatment
Reading at end of treatment SMD 0.27 (0.51 to 0.03)
Quality: High
K 1, N 267
Mathematics at end of treatment SMD 0.01 (0.25 to 0.23)
Quality: High
K 1, N 267
Education outcomes at 7–12 months post-treatment
Reading at 10 months post-treatment SMD 0.19 (0.43 to 0.05)
Quality: Moderate
K 1, N 273
Table 34: (Continued)
Continued
Combining and comparing psychological and pharmacological interventions
325
Combining and comparing psychological and pharmacological interventions
326
ADHD and community care participants might also have received non-pharmacological
interventions. It is also important to note that the MTA study was US based. Standard
care for ADHD in the US may differ from routine care in the UK, with the potential that
a higher proportion of the children with ADHD in the community care group received
medication than would be the case in a similar UK sample.
The MTA combined intervention was generally favoured over usual care on parent
and teacher ratings of ADHD symptoms and conduct problems. According to the
composite measure of teacher and parent ratings of core ADHD symptoms that is
reported for later follow-up assessments, comprehensive care continues to be favoured
over routine care 10 months after the end of the intervention, but the effect is only small.
Twenty-two months after the end of the intervention neither comprehensive care nor
routine care is favoured according to the composite measure of core ADHD symptoms.
However, measures of conduct problems point to an unequivocal advantage of compre-
hensive care over routine care. At the end of the intervention both parent and teacher
ratings of conduct behaviour favour comprehensive care over routine care, with a
moderate effect size. The composite score for parent and teacher ratings of conduct
behaviour reported for the later follow-up assessments indicates that the beneficial
effect of comprehensive care over routine care reduced to a small effect 10 months after
the end of treatment but increased to a large effect 22 months after the end of treatment.
Parent and teacher ratings of social skills at the end of the intervention also point
to small gains from comprehensive care over routine care, but these weak effects
Combined intervention versus
community care
Education outcomes at 7–12 months post-treatment
Reading 10 months post-treatment SMD 0.12 (0.37 to 0.13)
Quality: Moderate
K 1, N 243
Dichotomous outcomes
Leaving study for any reason RR 0.50 (0.13 to 1.97)
Quality: High
K 1, N 291
Non-responders at end of treatment RR 0.43 (0.33 to 0.55)
Quality: High
K 1, N 290
Non-responders at 10 months RR 0.72 (0.60 to 0.87)
post-treatment Quality: High
K 1, N 291
Table 34: (Continued)
disappear at the later follow-up assessments according to a composite measure that
combines parent and teacher ratings of social skills. In contrast, parent ratings of their
child’s emotional state point to a weak advantage of routine care over comprehensive
treatment at the end of the intervention, but teacher ratings at the end of the interven-
tion do not favour comprehensive treatment or routine care.
Taking all these findings into consideration there appears to be some benefit of a
comprehensive intervention for ADHD over routine care. Measures of core ADHD
symptoms at the end of the intervention indicate that comprehensive care is moder-
ately more effective for core ADHD symptoms than community care, and comprehen-
sive care may be particularly beneficial for conduct problems. It may be that the main
factor generating the positive effects of the combined intervention is the medication
management component. In any event, the comparison between outcomes for the
MTA combined intervention ‘comprehensive care’ group and the community care
group does not provide a consistent indication that comprehensive care is more effec-
tive than routine care that may include medication for ADHD. The advantage of
comprehensive treatment over routine care should also be considered in the context
of the lack of evidence of benefit from combined treatment approaches over active
protocol-determined medication regimens (see Section 11.2.4).
11.2.6 Clinical evidence summary
Evidence from trials comparing combined treatment with medication interventions
alone does not point to any added benefit of adding a psychological intervention to a
protocol determined medication regimen. The data therefore suggests that if medica-
tion treatment for ADHD has already been instigated and the child has responded
positively to treatment, then the addition of a psychological intervention to treat
ADHD (whether a parent training programme or child-directed therapy) is unlikely to
provide any added benefit in terms of reduced ADHD symptoms or improved behavi-
our, emotional state or self-esteem.
The findings on the effects of combined treatment therefore indicate that benefi-
cial effects of psychological interventions for ADHD are not dependent on effective
pharmacological treatment that allows the child with ADHD to be able to reap the
benefits of a psychological intervention. It may be the case that in combined treat-
ment trials the study-determined medication regimen has a large beneficial impact on
outcomes such that any additional beneficial effects of a psychological intervention
cannot be detected as there is no potential for any further improvement.
However, it should be noted that psychological interventions are effective as an
adjunct to usual care medication (see Chapter 7). This may be because medication is
less effective in routine clinical practice than in the context of a clinical trial. It is also
the case that the MTA study (MTA1999) suggests that combinations of interventions
may be helpful in targeting different problems and promoting some outcomes.
Offering combination interventions may therefore allow children and parents to
participate in treatment decisions and make choices about their own health outcomes
(Taylor et al., 2004).
Combining and comparing psychological and pharmacological interventions
327
Combining and comparing psychological and pharmacological interventions
328
11.3 COMPARING PSYCHOLOGICAL AND PHARMACOLOGICAL
INTERVENTIONS FOR CHILDREN WITH ADHD
11.3.1 Introduction
Direct comparison of the effectiveness of psychological and pharmacological interven-
tions for ADHD is possible where RCTs include a group receiving a psychological
intervention without medication and a group receiving medication only. Studies that
allow this comparison are potentially informative as they allow a direct head-to-head
comparison of effectiveness between psychological and pharmacological interventions.
11.3.2 Databases searched and inclusion/exclusion criteria
Information about the databases searched and the inclusion/exclusion criteria used for
this section of the guideline can be found in Table 35 (further information about the
search for health economic evidence can be found in Section 11.5). Studies were only
included where both the medication and psychological interventions were determined
as part of the study protocol.
11.3.3 Studies considered
34
From the primary RCT search, the review team identified trials comparing medica-
tion for ADHD with a psychological intervention.
Electronic databases MEDLINE, EMBASE, PsycINFO,
Cochrane Library
Date searched Database inception to December 2007
Study design RCT
Patient population Participants (all ages) diagnosed with ADHD
Interventions Medication for ADHD; psychological intervention
Outcomes Core ADHD symptoms; conduct problems; social
skills; emotional outcomes; self-efficacy; reading;
mathematics; leaving the study early; non-response to
treatment
Table 35: Databases searched and inclusion/exclusion criteria for
clinical effectiveness of psychological interventions
34
Here and elsewhere in the guideline, each study considered for review is referred to by a study ID in
capital letters (primary author and date of study publication, except where a study is in press or only
submitted for publication, then a date is not used).
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