Single and Combined Effects of Multiple Intensities of Behavioral Modification and Methylphenidate for Children with ADHD in the Home Setting.

Behavioral treatment, stimulants, and their combination are the recommended treatments for childhood attention-deficit/hyperactivity disorder (ADHD). The current study utilizes within-subjects manipulations of multiple doses of methylphenidate (placebo, 0.15, 0.30, and 0.60 mg/kg/dose t.i.d.) and intensities of behavioral modification (no, low, and high intensity) in the summer treatment program (STP) and home settings. Outcomes are evaluated in the home setting. Participants were 153 children (ages 5-12) diagnosed with ADHD. In alignment with experimental conditions implemented during the STP day, parents implemented behavioral modification levels in three-week intervals, child medication status varied daily, and the orders were randomized. Parents provided daily reports of child behavior, impairment, and symptoms and self-reported parenting stress and self-efficacy. At the end of the study, parents reported treatment preferences. Stimulant medication led to significant improvements across all outcome variables with higher doses resulting in greater improvement. Behavioral treatment significantly improved child individualized goal attainment, symptoms, and impairment in the home setting and parenting stress and self-efficacy. Effect sizes indicate that behavioral treatment combined with a low-medium dose (0.15 or 0.30 mg/kg/dose) of medication results in equivalent or superior outcomes compared to a higher dose (0.60 mg/kg/dose) of medication alone. This pattern was seen across outcomes. Parents overwhelmingly reported preferring treatment with a behavioral component as a first-choice treatment (99%). Results underscore the need to consider dosing as well as parent preference when utilizing combined treatment approaches. This study provides further evidence that combining behavioral treatment and stimulant medication may reduce the stimulant dose needed for beneficial effects.

Randomized Trial of First-Line Behavioral Intervention to Reduce Need for Medication in Children with ADHD.

A study conducted in an analogue summer treatment setting showed that when concurrently receiving behavioral intervention, many children with Attention-Deficit Hyperactivity Disorder (ADHD) did not need medication or maximized responsiveness at very low doses. The present study followed participants in that summer study into the subsequent school year to investigate whether the same pattern would extend to the natural school and home settings. There were 127 unmedicated children with ADHD between the ages of 5 and 13 who were randomly assigned to receive or not receive behavioral consultation (BC) at the start of the school year. Children were evaluated by teachers and parents each week to determine if central nervous system stimulant treatment was needed. Children who received BC were approximately half as likely those who did not (NoBC) to initiate medication use each week at school or home and used lower doses when medicated at school. This produced a 40% reduction in total methylphenidate exposure over the course of the school year. BC and NoBC groups did not significantly differ on end-of-year teacher or parent ratings of behavior, which were positive. Moreover, BC and NoBC groups did not significantly differ in cost of treatment; although children in the BC condition accrued additional costs via the BC, these costs were offset by the associated delay and reduction in medication use. Results add to a growing literature suggesting that the use of low-intensity behavioral intervention as a first-line treatment reduces or eliminates the need for medication in children with ADHD.

Effects of behavioral and pharmacological therapies on peer reinforcement of deviancy in children with ADHD-only, ADHD and conduct problems, and controls.

OBJECTIVE: This study compared the unique and combined effects of evidence-based treatments for ADHD-stimulant medication and behavior modification-on children's rates of reinforcement for deviant peer behavior (RDPB). METHOD: Using a within-subjects design, 222 elementary school-age children attending a summer treatment program, including 151 children with ADHD (127 male), with and without comorbid conduct problems, and 71 control children (57 male), received varying combinations of behavior modification (no, low-intensity, and high-intensity) and methylphenidate (placebo, 0.15 mg/kg, 0.30 mg/kg, and 0.60 mg/kg). RDPB was measured through direct observation and compared across all behavior modification and medication conditions. RESULTS: Children with ADHD reinforced the deviant behavior of their peers at a significantly higher rate than control children in the absence of either intervention. However, that difference largely disappeared in the presence of both behavior modification and medication. Both low and high-intensity behavior modification, as well as medium (0.30 mg/kg) and high (0.60 mg/kg) doses of methylphenidate, significantly reduced the rate of ADHD children's RDPB to levels similar to the control group. CONCLUSIONS: Results indicate that although untreated children with ADHD do engage in RDPB at a greater rate than their non-ADHD peers, existing evidence-based interventions can substantially decrease the presence of RDPB, thereby limiting potential iatrogenic effects in group-based treatment settings.

A dose-ranging study of behavioral and pharmacological treatment in social settings for children with ADHD.

Placebo and three doses of methylphenidate (MPH) were crossed with 3 levels of behavioral modification (no behavioral modification, NBM; low-intensity behavioral modification, LBM; and high-intensity behavior modification, HBM) in the context of a summer treatment program (STP). Participants were 48 children with ADHD, aged 5-12. Behavior was examined in a variety of social settings (sports activities, art class, lunch) that are typical of elementary school, neighborhood, and after-school settings. Children received each behavioral condition for 3 weeks, order counterbalanced across groups. Children concurrently received in random order placebo, 0.15 mg/kg/dose, 0.3 mg/kg/dose, or 0.6 mg/kg/dose MPH, 3 times daily with dose manipulated on a daily basis in random order for each child. Both behavioral and medication treatments produced highly significant and positive effects on children's behavior. The treatment modalities also interacted significantly. Whereas there was a linear dose-response curve for medication in NBM, the dose-response curves flattened considerably in LBM and HBM. Behavior modification produced effects as large as moderate doses, and on some measures, high doses of medication. These results replicate and extend to social-recreational settings previously reported results in a classroom setting from the same sample (Fabiano et al., School Psychology Review, 36, 195-216, 2007). Results illustrate the importance of taking dosage/intensity into account when evaluating combined treatments; there were no benefits of combined treatments when the dosage of either treatment was high but combination of the low-dose treatments produced substantial incremental improvement over unimodal treatment.

A discrete choice conjoint experiment to evaluate parent preferences for treatment of young, medication naive children with ADHD.

The current study examined treatment preferences of 183 parents of young (average age = 5.8 years, SD = 0.6), medication naive children with ADHD. Preferences were evaluated using a discrete choice experiment in which parents made choices between different combinations of treatment characteristics, outcomes, and costs. Latent class analysis yielded two segments of parents: (a) medication avoidant parents constituted 70.5% of the sample whose treatment decisions were strongly influenced by a desire to avoid medication, and (b) outcome oriented parents constituted 29.5% of the sample whose treatment decisions were most influenced by a desire for positive treatment outcomes. Parents in the outcome oriented segment were more stressed and depressed, had lower socioeconomic status and education, were more likely to be single parents, and had more disruptive and impaired children. Simulations predicted that parents would prefer treatments with behavior therapy over treatments with stimulant medication only.

Efficacy of a methylphenidate transdermal system versus t.i.d. methylphenidate in a laboratory setting.

OBJECTIVE: To test the efficacy and tolerability of the methylphenidate transdermal formulation (MTS) against immediate-release methylphenidate (IR MPH) and placebo in a 12-hr analog classroom setting. METHOD: A total of nine boys ages 6 to 9 years, medicated with MPH for ADHD, complete a within-subject, double-blind study. For the purpose of the study, the boys are administered a dose of 20 cm(2) MTS, a matched dose of IR MPH 10 mg TID, and placebo. ADHD symptoms and frequency counts of classroom rule violations and the number of math problems completed are assessed hourly, during three consecutive analog classroom sessions. RESULTS: Findings show that, across measures and throughout the day, both treatments significantly differentiated from placebo (p < .05) but not from each other. It is also observed that the MTS produced more consistent results across the day but had a delayed onset versus IR MPH. Both medications are well tolerated with only mild reductions in sleep onset. CONCLUSION: The MTS demonstrates comparable efficacy and tolerability to TID IR MPH.

The efficacy and tolerability of methylphenidate and behavior modification in children with attention-deficit/hyperactivity disorder and severe mood dysregulation.

OBJECTIVES: This study examines the tolerability and efficacy of methylphenidate (MPH) and behavior modification therapy (BMOD) in children with attention-deficity/hyperactivity disorder (ADHD) and severe mood dysregulation (SMD). METHODS: Children (ages 5-12) from a summer program for ADHD were screened for SMD and additional manic-like symptoms using structured assessments and direct clinical interview with the Young Mania Rating Scale (YMRS). The SMD group was comprised of 33 subjects with SMD and elevated YMRS scores (mean = 23.7). They underwent weekly mood assessments plus the daily ADHD measures that are part of the program. The comparison group (n = 68) was comprised of the rest of the program participants. Using a crossover design, all subjects in both groups were treated with three varying intensities of BMOD (no, low, high) each lasting 3 weeks, with MPH dose (placebo, 0.15 mg/kg t.i.d., 0.3mg/kg t.i.d., and 0.6 mg/kg t.i.d.) varying daily within each behavioral treatment. RESULTS: Groups had comparable ADHD symptoms at baseline, with the SMD group manifesting more oppositional defiant disorder/conduct disorder (ODD/CD) symptoms (p < 0.001). Both groups showed robust improvement in externalizing symptoms (p < 0.001). There was no evidence of differential treatment efficacy or tolerability. Treatment produced a 34% reduction in YMRS ratings in SMD subjects (p - 0.001). However, they still exhibited elevated YMRS ratings, more ODD/CD symptoms (p < 0.001), and were more likely to remain significantly impaired at home than non-SMD subjects (p < 0.05). CONCLUSIONS: MPH and BMOD are tolerable and effective treatments for children with ADHD and SMD, but additional treatments may be needed to optimize their functioning.

A practical measure of impairment: psychometric properties of the impairment rating scale in samples of children with attention deficit hyperactivity disorder and two school-based samples.

Assessing impairment is an explicit component of current psychiatric diagnostic systems. A brief parent and teacher rating scale for assessing impairment was developed and studied using attention deficit hyperactivity disorder (ADHD) as an exemplar disorder. The psychometric properties of the Impairment Rating Scale (IRS) were measured in 4 samples. Two included ADHD and matched comparison children and the other 2 a school sample. Overall, IRS ratings exhibited very good temporal stability. They correlated with other impairment ratings and behavioral measures and displayed evidence of convergent and discriminant validity. The IRS was highly effective in discriminating between children with and without ADHD. Evidence that the parent and teacher IRS accounted for unique variance beyond ratings of ADHD symptoms is also presented. The scale is brief, practical, and in the public domain. The results of the studies and implications for the assessment of impairment are discussed.

Transdermal methylphenidate, behavioral, and combined treatment for children with ADHD.

Stimulant medication and behavioral treatments are evidence-based for children with attention-deficit/hyperactivity disorder, but the combination of the 2 treatments has been understudied. In this investigation, methylphenidate (MPH) was crossed with 2 levels of behavior modification (BMOD) in a summer treatment program. Twenty-seven children with attention-deficit/hyperactivity disorder, aged 6-12, participated. Children received placebo and 3 doses of transdermal MPH (12.5 cm(2), 25.0 cm(2), and 37.5 cm(2)). BMOD was implemented on alternating weeks. Both treatments produced large and significant effects. Combined treatment was superior to either treatment alone. The effects of transdermal MPH were comparable to those found in this setting in previous studies with multiple stimulant medications and formulations. Consistent with other research, low doses of MPH--even lower than in previous studies--yielded enhanced effects in combination with behavior modification.

A dose-ranging study of a methylphenidate transdermal system in children with ADHD.

OBJECTIVE: This was a multicenter, double-blind, randomized, dose-ranging study of a methylphenidate (MPH) transdermal system (MTS). Medication (placebo, 0.45, 0.9, and 1.8 mg/h) was crossed with application time (6 a.m., 7 a.m.) to evaluate MTS efficacy and influence of exposure time on morning effects. METHOD: The study took place in a summer treatment program (STP) at three sites, with 36 children aged 7-12 years with attention-deficit/hyperactivity disorder. Each treatment was administered for 1 day in random order, for a total of 8 days. Behavioral and academic measures were taken as well as patch wear characteristics and side effects. RESULTS: Evaluable participant data were analyzed in a series of dose x application time multivariate analyses of variance. All MTS conditions were significantly different from placebo across measures. Time of application had no significant effect on daily behavior, and effects of application time on morning behavior were inconclusive. Consistent with previous results in this setting, the highest dose produced limited incremental benefit compared with the mid-range dose. The wear characteristics of the MTS were acceptable, and the formulation was well tolerated. CONCLUSIONS: The MTS produced significant effects that were similar to those previously reported with comparable MPH doses. There does not appear to be a substantial effect of application time on total daily functioning in this setting; further controlled time-course studies will be necessary to evaluate the question of morning onset fully.