Faculty Bibliography

OBJECTIVE:: To evaluate the effects of stimulant medication on organizational, time management, and planning (OTMP) in children with attention-deficit/hyperactivity disorder (ADHD) and ascertain whether OTMP is normalized with medication. METHOD:: Participants included 19 stimulant-naive children with ADHD (aged 8-13 years) and impaired OTMP functioning, defined as greater than 1 SD below norms on the Children's Organizational Skills Scale. A double-blind, placebo-controlled, crossover design, with 4 weeks of each condition, evaluated medication (methylphenidate-osmotic-release oral system [MPH-OROS]) effects on OTMP, based on the parent and teacher versions of the Children's Organizational Skills Scale. The parent and teacher Swanson, Nolan, and Pelham, Version IV, rating scales assessed ADHD symptoms. 'Not impaired' in OTMP was defined as no longer meeting study entry criteria, and 'not impaired' in ADHD symptoms was defined as having mean Swanson, Nolan, and Pelham, Version IV, scores of </=1.0. RESULTS:: MPH-OROS significantly improved children's OTMP behaviors. These improvements were correlated with significant reductions in ADHD symptoms. However, most of the children (61%) continued to show significant OTMP impairments on MPH-OROS. CONCLUSIONS:: The MPH-OROS reduced children's OTMP deficits, and these improvements were associated with improvements in ADHD symptoms. Some children remained impaired in OTMP even after effective stimulant treatment of ADHD symptoms. These youngsters may require other treatments that target OTMP deficits

The revised new forest parenting programme (NFPP) is an 8-week psychological intervention designed to treat ADHD in preschool children by targeting, amongst other things, both underlying impairments in self-regulation and the quality of mother-child interactions. Forty-one children were randomized to either the revised NFPP or treatment as usual conditions. Outcomes were ADHD and ODD symptoms measured using questionnaires and direct observation, mothers' mental health and the quality of mother-child interactions. Effects of the revised NFPP on ADHD symptoms were large (effect size >1) and significant and effects persisted for 9 weeks post-intervention. Effects on ODD symptoms were less marked. There were no improvements in maternal mental health or parenting behavior during mother-child interaction although there was a drop in mothers' negative and an increase in their positive comments during a 5-min speech sample. The small-scale trial, although limited in power and generalizability, provides support for the efficacy of the revised NFPP. The findings need to be replicated in a larger more diverse sample

BACKGROUND: Short-term treatment with the meth-ylphenidate transdermal system (MTS) has been well tolerated in several clinical trials in children with attention-deficit/hyperactivity disorder (ADHD). However, the effects of long-term use have not been systematically evaluated. OBJECTIVES: The primary objective of this study was to assess the 12-month tolerability of MTS in children with ADHD. Effectiveness was a secondary objective. METHODS: This Phase III study was a multicenter, 12-month, open-label, flexible-dose extension of 4 previous trials. In those studies, children aged 6 to 12 years with a diagnosis of ADHD (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria) received MTS, osmotic-release oral system methylphenidate, or placebo. At entry into the present study, the children either continued to receive their optimal dose of MTS (10, 15, 20, or 30 mg per 9-hour patch wear time) or underwent dose titration over 4 weeks to an optimal MTS dose, which was continued for the remainder of the study. Tolerability was evaluated based on adverse events (AEs), physical examinations, vital signs, electrocardiograms, laboratory tests, the Children's Sleep Habits Questionnaire, and the occurrence of application-site reactions. RESULTS: Of 327 enrolled subjects, 326 received treatment and 157 completed the study. The majority of enrolled subjects were male (64.8%) and white (73.7%), with a mean (SD) age of 9.2 (1.9) years. Two hundred sixty-five (81.3%) of the 326 subjects who received MTS reported AEs. AEs led to study discontinuation in 29 subjects (8.9%). The majority (98.3%) of treatment-emergent AEs were of mild or moderate severity. The most common AEs were decreased appetite (24.8%), headache (16.6%), upper respiratory tract infection (12.3%), cough (11.7%), pyrexia (10.1%), and decreased weight (10.1%). Of the 1118 AEs, 40.8% were considered possibly or probably related to study treatment. Three serious AEs (facial contusion, ankle fracture, and syncope) occurred and were considered unrelated to study treatment. Based on data collected across all study visits, application-site reactions generally consisted of mild erythema associated with mild discomfort at the patch site. Application-site reactions accounted for 22 (6.7%) study discontinuations. CONCLUSIONS: Slightly less than half (48.0%) of subjects completed this 12-month, open-label extension study of MTS. Most AEs were mild to moderate in severity and, with the exception of application-site reactions, were typical of those previously observed with methylphenidate. ClinicalTrials.gov identifier: NCT00151957

OBJECTIVE: 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. METHOD: 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). RESULTS: 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. CONCLUSIONS: 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

OBJECTIVE: To review the primary and secondary findings from the Multimodal Treatment study of ADHD (MTA) published over the past decade as three sets of articles. METHOD: In a two-part article-Part I: Executive Summary (without distracting details) and Part II: Supporting Details (with additional background and detail required by the complexity of the MTA)-we address confusion and controversy about the findings. RESULTS: We discuss the basic features of the gold standard used to produce scientific evidence, the randomized clinical trial, for which was used to contrast four treatment conditions: medication management alone (MedMgt), behavior therapy alone (Beh), the combination of these two (Comb), and a community comparison of treatment 'as usual' (CC). For each of the three assessment points we review three areas that we believe are important for appreciation of the findings: definition of evidence from the MTA, interpretation of the serial presentations of findings at each assessment point with a different definition of long-term, and qualification of the interim conclusions about long-term effects of treatments for ADHD. CONCLUSION: 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

This case study illustrates a behavioral treatment of 'Peter,' a 4-year-old male with attention deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder. Multiple evidence-based treatment procedures were implemented, affording the opportunity to explore issues common to the clinical application of empirically supported interventions. Among the strategies utilized were behavioral parent training, school consultation and behavioral training of educators, school-based contingency management, and a behavioral daily report card. Numerous issues are discussed, including the limited evidence regarding interventions for preschool-age children with ADHD, factors influencing treatment planning and sequencing, collaboration with schools and parents, and evidence-based assessment of treatment gains

Patient perspectives represent an increasingly important focus in clinical trials of medical treatments for pediatric mental health conditions. This paper describes the development and initial testing of a short, easy to complete, condition specific, measure of patients' and their parents' attitudes regarding drugs used for the treatment of their attention-deficit/hyperactivity disorder (ADHD)--the Southampton ADHD Medication Behaviour and Attitudes scale. On the basis of an initial qualitative study and pilot data, subscales were constructed for both the child and parent versions covering perceived costs and benefits of treatment, patient stigma, and resistance to treatment. The parent version had additional subscales for parental stigma, treatment inconsistency, and flexibility. Factor and reliability analysis of data from 356 parents and 123 of their children supported the distinction between these subscale domains. Children were aged between 5 and 18 years (mean age 10.95 years). Parent and child scores were correlated, although as in previous research parents rated ADHD medications as having more benefits and children rated them as having more costs. The Southampton ADHD Medication Behaviour and Attitudes scale represents a useful addition to the growing portfolio of patient-reported outcomes for ADHD treatments. Future research should focus on the scales value in predicting treatment adherence as it impacts on medication effectiveness