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We examined 9-month data from the 14-month NIMH Multimodal Treatment Study of Children with ADHD (the MTA) as a further check on the relative effect of medication (MedMgt) and behavioral treatment (Beh) for attention-deficit/hyperactivity disorder (ADHD) while Beh was still being delivered at greater intensity than at 14-month endpoint, and convers...
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... slopes) showed no significant differences, either on omnibus tests or paired comparisons of treatment groups. The data presented do not support the hypotheses that Beh was closer to MedMgt and farther from CC at 9 months or that Comb was more superior to MedMgt at 9 months. For these analyses, we set significance at a liberal p = . 05. Even so, none of the pairwise comparisons is significant, suggesting similarity of change slopes from 9 to 14 months among the treatment groups. For the main outcome measure, no comparison even ap- proached significance ( p > . 2), and no measure had a comparison significant at p = . 05. Most of the nonsignificant (and small effect) tendencies that can be detected from inspection of effect sizes contradict the hypotheses. They show MedMgt nominally more superior to Beh at 9 months than at 14 months on six of the seven measures, Comb nominally more superior to Beh at 9 months than at 14 months on five of the seven measures, and Comb less nominally superior to MedMgt at 9 months than at 14 months on three measures, in all cases including the primary measure. Table 3 shows the Pearson correlation coefficients between the baseline-to-9-month slope and the baseline- to-14-month slope. All correlations are very highly significant, suggesting similarity of the baseline-to-9-month improvement slope to the baseline-to-14-month slope—i.e., similarity of the 9-month results to the 14-month results. The correlations are remarkably similar across treatment groups, and treatment group contrasts are not significant, confirming that the relationship of the two slopes is similar across all treatment groups. Figure 2 visually displays the three timepoints and Table IV shows the tests of quadratic time effect from baseline to 14 months. In contrast to the linear effect, which is uniformly highly significant for all treatment groups, the quadratic effect is significant for the SNAP composite for CC only ( p < . 05), suggesting that the trajectory for Beh did not deviate after 9 months. However, on the secondary measures, Beh (as well as CC) has a significant quadratic time effect for parent- and teacher-rated internalizing symptoms. On those two measures Beh (and CC) improved from 9 to 14 months. In fact, all four groups improved from 9 to 14 months with a significant quadratic effect for parent-rated internalizing symptoms. Overall, Beh had two measures with quadratic effect significant at p < . 05 compared to three for Comb, two for ...
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... We were able to construct an analogue testing environment for our child-parent dyads that elicited undesirable behaviors and then demonstrated sensitivity to change over time for some of our salient variables (Hayes 2001). Our finding of an effect of treatment and amount of reinforcement is in line with research from Wells et al. (2006), who found the MTA multimodal treatment resulted in greater gains in proactive parenting over time, consistent with primary outcomes improving further (from 9 months to 14 months) after cessation of intensive behavior treatment (Arnold et al. 2004). The same group found that reduction of negative parenting mediated teacher-rated response to medication at school (Hinshaw et al. 2000). ...
Objective:
To explore blinded observational outcomes in the Treatment of Severe Childhood Aggression (TOSCA) study.
Methods:
During a 9-week acute trial, children with severe physical aggression and attention-deficit/hyperactivity disorder received parent training + titrated psychostimulant for 3 weeks, and those who failed to show an optimal response during Week 4 through Week 6 received in addition either randomly assigned placebo (Basic treatment) or titrated risperidone (Augmented treatment). Child and parent behaviors were videotaped in a Standardized Observation Analogue Procedure (SOAP) designed to elicit problems and strengths in child and parent interactions. SOAPs were collected at baseline and Week 9 and 52 follow-up.
Results:
During the acute 9-week trial, augmented treatment was associated with better outcomes than basic treatment for 3 of 13 measures: increased Child Compliance (p = 0.004; significant after correction for multiple tests), greater use of positive Parent Reinforcement (p = 0.03), and more Shared Enjoyment (p = 0.04). At follow-up, when medication was no longer by randomized assignment, parents used more Alpha Commands and displayed fewer Parent Negative Behaviors, and the dyads showed more Shared Enjoyment regardless of original randomization. Thus, there were better parent-child interactions with Augmented treatment, and interactions improved overall at follow-up regardless of original treatment assignment.
Conclusions:
The SOAP demonstrated sensitivity to behavior changes between short-term treatments for a few (but not most) measures. The acute treatment differences for Child Compliance and Child Negative Behavior are generally consistent with the moderate superiority of Augmented over Basic treatment previously reported for the primary study outcome.
... Although the MTA sample was not selected for severe aggression as this one was, 54% did have a comorbid DBD (MTA Cooperative Group 1999a). In the MTA, the treatment groups assigned study-supplied medication fared significantly better for 14 months than the group who received treatment as usual in the community (MTA Cooperative Group 1999b; Arnold et al. 2004). At the 24-month follow-up, the ran-domly assigned MTA treatment groups still differed significantly in both symptoms and medication use, with the medication difference mediating the symptom difference (MTA Cooperative Group 2004). ...
Objectives:
Previous "Treatment of Severe Childhood Aggression" (TOSCA) reports demonstrated that many children with severe physical aggression and attention-deficit/hyperactivity disorder (ADHD) responded well to two randomized treatments (parent training [PT]+stimulant+placebo = Basic vs. PT+stimulant+risperidone = Augmented) for 9 weeks. An important clinical question is whether these favorable outcomes are maintained over longer times.
Methods:
Clinical responders to the 9-week trial (n = 103/168), defined as Clinical Global Impressions (CGI)-Improvement of much/very much improved plus substantial reduction in parent ratings of disruptiveness, were followed another 12 weeks (21 weeks total) while remaining on blinded treatment. Outcome measures included Clinical Global Impressions scale, Nisonger Child Behavior Rating Form (NCBRF), other parent/teacher-rated scales, laboratory tests, clinician ratings of abnormal movement, and other adverse events (AEs).
Results:
Parent ratings of problem behavior showed minimal worsening of behavior from end of the 9-week acute trial (expected from regression to the mean after selecting best responders), but outcomes at Extension endpoint were meaningfully improved compared with acute study baseline. As expected, outcomes for Basic and Augmented treatment did not differ among these children selected for good clinical response. During Extension, more Augmented subjects had elevated prolactin; there were no clinically confirmed cases of tardive dyskinesia. Delayed sleep onset was the most frequent Basic AE. We also conducted a last-observation-carried-forward analysis, which included both nonresponders and responders. We found that, at the end of Extension, Augmented subjects had more improvement than Basic subjects on the NCBRF Positive Social subscale (p = 0.005; d = 0.44), the Antisocial Behavior Scale Reactive Aggression subscale (p = 0.03; d = 0.36), and marginally so on the Disruptive Behavior Total subscale (p = 0.058; d = 0.29, the primary outcome).
Conclusions:
The medium-term outcomes were good for the participants in both treatment groups, perhaps because they were selected for good response. When nonresponders were included in ITT analyses, there was some indication that Augmented surpassed Basic treatment.
... In both studies, the beneficial effects of added behavioral treatment seemed to increase over time. 51 Other important differences are that the behavioral intervention in the MTA was more intensive and delivered over a greater period of time than the PT program in our study. Thus, the behavioral treatment tested here produced additive benefit at lower cost than the MTA study, albeit for a different population and target symptoms. ...
Disruptive behavior is common in children with autism spectrum disorder. Behavioral interventions are used to treat disruptive behavior but have not been evaluated in large-scale randomized trials.
To evaluate the efficacy of parent training for children with autism spectrum disorder and disruptive behavior.
This 24-week randomized trial compared parent training (n = 89) to parent education (n = 91) at 6 centers (Emory University, Indiana University, Ohio State University, University of Pittsburgh, University of Rochester, Yale University). We screened 267 children; 180 children (aged 3-7 years) with autism spectrum disorder and disruptive behaviors were randomly assigned (86% white, 88% male) between September 2010 and February 2014.
Parent training (11 core, 2 optional sessions; 2 telephone boosters; 2 home visits) provided specific strategies to manage disruptive behavior. Parent education (12 core sessions, 1 home visit) provided information about autism but no behavior management strategies.
Parents rated disruptive behavior and noncompliance on co-primary outcomes: the Aberrant Behavior Checklist-Irritability subscale (range, 0-45) and the Home Situations Questionnaire-Autism Spectrum Disorder (range, 0-9). On both measures, higher scores indicate greater severity and a 25% reduction indicates clinical improvement. A clinician blind to treatment assignment rated the Improvement scale of the Clinical Global Impression (range, 1-7), a secondary outcome, with a positive response less than 3.
At week 24, the Aberrant Behavior Checklist-Irritability subscale declined 47.7% in parent training (from 23.7 to 12.4) compared with 31.8% for parent education (23.9 to 16.3) (treatment effect, -3.9; 95% CI, -6.2 to -1.7; P < .001, standardized effect size = 0.62). The Home Situations Questionnaire-Autism Spectrum Disorder declined 55% (from 4.0 to 1.8) compared with 34.2% in parent education (3.8 to 2.5) (treatment effect, -0.7; 95% CI, -1.1 to -0.3; P < .001, standardized effect size = 0.45). Neither measure met the prespecified minimal clinically important difference. The proportions with a positive response on the Clinical Global Impression-Improvement scale were 68.5% for parent training vs 39.6% for parent education (P < .001).
For children with autism spectrum disorder, a 24-week parent training program was superior to parent education for reducing disruptive behavior on parent-reported outcomes, although the clinical significance of the improvement is unclear. The rate of positive response judged by a blinded clinician was greater for parent training vs parent education.
clinicaltrials.gov Identifier: NCT01233414.
... In both studies, the beneficial effects of added behavioral treatment seemed to increase over time. 51 Other important differences are that the behavioral intervention in the MTA was more intensive and delivered over a greater period of time than the PT program in our study. Thus, the behavioral treatment tested here produced additive benefit at lower cost than the MTA study, albeit for a different population and target symptoms. ...
Objective:
In this study, we aimed to expand on our prior research into the relative efficacy of combining parent training, stimulant medication, and placebo (Basic therapy) versus parent training, stimulant, and risperidone (Augmented therapy) by examining treatment effects for attention-deficit/hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD) symptoms and peer aggression, symptom-induced impairment, and informant discrepancy.
Method:
Children (6-12 years of age; N = 168) with severe physical aggression, ADHD, and co-occurring ODD/CD received an open trial of parent training and stimulant medication for 3 weeks. Participants failing to show optimal clinical response were randomly assigned to Basic or Augmented therapy for an additional 6 weeks.
Results:
Compared with Basic therapy, children receiving Augmented therapy experienced greater reduction in parent-rated ODD severity (p = .002, Cohen's d = 0.27) and peer aggression (p = .02, Cohen's d = 0.32) but not ADHD or CD symptoms. Fewer children receiving Augmented (16%) than Basic (40%) therapy were rated by their parents as impaired by ODD symptoms at week 9/endpoint (p = .008). Teacher ratings indicated greater reduction in ADHD severity (p = .02, Cohen's d = 0.61) with Augmented therapy, but not for ODD or CD symptoms or peer aggression. Although both interventions were associated with marked symptom reduction, a relatively large percentage of children were rated as impaired for at least 1 targeted disorder at week 9/endpoint by parents (Basic 47%; Augmented 27%) and teachers (Basic 48%; Augmented 38%).
Conclusion:
Augmented therapy was superior to Basic therapy in reducing severity of ADHD and ODD symptoms, peer aggression, and symptom-induced impairment, but clinical improvement was generally context specific, and effect sizes ranged from small to moderate. Clinical trial registration information-Treatment of Severe Childhood Aggression (The TOSCA Study); http://clinicaltrails.gov/; NCT00796302.
... – Barkley et al. (2000) 40, 37 4.85 63 Average 43 En BPT Other Tx P, C, T Gr 7 À.01 – Burrows (2000) 19, 19 – – – – En BPT Other Tx P, C Gr 4 .77 – Wells et al. (2000) (2006) f , Arnold et al. (2004) ...
... This was based on similar questionnaires in the research literature and adapted by the clinic staff. [25][26][27][28] The Likert scale questionnaire was composed mainly of 'closed' statements. 8,11,24,29 There was also free response. ...
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The majority of families and professionals strongly agreed that a specialist assessment was needed in this population. Parents and professionals particularly valued the written report which provided guidance on appropriate visual material including advice relevant to education.
This study highlights the importance of specialist teams engaging with local child development services and indicates how partnership working can potentially be emotionally supportive as well as developmentally beneficial.
... Für die klinischen Wirkungen der Verhaltenstherapie konnte belegt werden, dass diese auch nach Beendigung bzw. Ausschleichen der Interventionen über die verbleibende Studiendauer anhielten [45]. Diesbezüglich scheint sich eine Verhaltenstherapie vorteilhaft von den ganz oder überwiegend [35] auf die Dauer der Einnahme begrenzten Effekten einer Stimulanziengabe zu unterscheiden. ...
In the German region of Nordbaden, 5% of children (aged 7–12 years) and 1.3% of adolescents (aged 13–19 years) were diagnosed with attention deficit hyperactivity disorder (ADHD) in 2003. About two thirds of these patients were not seen by a physician specialized in psychiatry. Now the National Association of Statutory Health Insurance Physicians in Germany (Kassenaerztliche Bundesvereinigung, KBV) has developed a proposal for the integrated provision of care for these patients, combining a guidelines-oriented multidisciplinary approach with a system of quality assurance. Against this background, currently available ADHD-related data are presented, covering epidemiology, comorbidity and differential diagnosis, health care utilization, and cost of illness. According to administrative data analyses from Nordbaden, direct medical costs for patients with ADHD, from the perspective of statutory health insurance (SHI), exceed those of matched controls by a factor of >2.5. On this basis, ADHD-related expenditures of the German SHI may be estimated at around EUR 260 million in 2003, and almost certainly will have continued to grow further since. In addition to this, a diagnosis of ADHD is associated with substantial indirect cost. Although the literature on the burden of ADHD is incomplete, it seems plausible that the cost of illness might be comparable to that reported for alcohol and addiction disorders. Thus we anticipate an increasing relevance of formal health economic evaluations of health care programs offered to patients with ADHD.
... We know a great deal about comprehensive psychological treatment for ADHD on its own and with medications (Arnold et al., 2004;Cunningham, 1999;Jensen et al., 2001). The research on the efficacy of psychological management for ADHD developed and delivered by experts in well-designed trials is extensive (Pelham, Wheeler, & Chronis, 1998). ...
... In both studies, the beneficial effects of added behavioral treatment seemed to increase over time. 51 Other important differences are that the behavioral intervention in the MTA was more intensive and delivered over a greater period of time than the PT program in our study. Thus, the behavioral treatment tested here produced additive benefit at lower cost than the MTA study, albeit for a different population and target symptoms. ...
... The short-term effects of MedMgt were evaluated in a double-blind 30-day titration trial, which verified beneficial effects manifested by reduction of ADHD symptoms and related behaviors on the first day, during the first week, and over the first month of treatment (Greenhill et al., 2001). Intermediate effects were estimated from the assessments at 3 months and 9 months after randomization (see Arnold et al., 2004). Also, intermediate effects were provided by a comparison of two treatments (Comb and Beh) during the implementation of one component of behavior therapy, the summer treatment program (Pelham et al., 2000). ...
To review and provide details about the primary and secondary findings from the Multimodal Treatment study of ADHD (MTA) published during the past decade as three sets of articles.
In the second of a two part article, we provide additional background and detail required by the complexity of the MTA to address confusion and controversy about the findings outlined in part I (the Executive Summary).
We present details about the gold standard used to produce scientific evidence, the randomized clinical trial (RCT), which we applied to evaluate the long-term effects of two well-established unimodal treatments, Medication Management (MedMGT) and behavior therapy (Beh), the multimodal combination (Comb), and treatment "as usual" in the community (CC). For each of the first three assessment points defined by RCT methods and included in intent-to-treat analyses, we discuss our definition of evidence from the MTA, interpretation of the serial presentations of findings at each assessment point with a different definition of long-term varying from weeks to years, and qualification of the interim conclusions about long-term effects of treatments for ADHD based on many exploratory analyses described in additional published articles.
Using a question and answer format, we discuss the possible clinical relevance of the MTA and present some practical suggestions based on current knowledge and uncertainties facing families, clinicians, and investigators regarding the long-term use of stimulant medication and behavioral therapy in the treatment of children with ADHD.
