|Title:||Adaptive Treatments for Children with ADHD|
|Principal Investigator:||Pelham, William||Awardee:||Florida International University|
|Program:||Social and Behavioral Outcomes to Support Learning [Program Details]|
|Award Period:||4/1/2006 to 3/31/2010||Award Amount:||$2,711,468|
|Goal:||Efficacy and Replication||Award Number:||R324B060047|
Previous Award Number: R324B060045
Purpose: The purpose of this study is to investigate the efficacy of two forms of ADHD treatment: medication and behavioral intervention. Unlike previous research, this study proposes to examine the effect of sequential implementation of the two forms of ADHD treatment on students unresponsive to the primary intervention. By using sequential implementation of either medication followed by behavioral intervention or behavioral intervention followed by medication, students with ADHD will receive the lowest effective dosage of medication and/or intensity of behavioral intervention; therefore, costs will be reduced and students will not be subjected to unnecessary interventions.
Project Activities: One hundred forty-four children with ADHD, between the ages of 6 and 12, will be recruited to participate in a study in which they will be assigned to one of two treatment groups: (1) Treatment beginning with a low dose of medication, or (2) Treatment beginning with a low intensity behavioral intervention. After 8 weeks of treatment, children will be assessed for response to treatment. If additional treatment is needed, children will be randomized again to either (a) augment the existing treatment (i.e., increase medication dose or behavioral intensity) or (b) add other modality (i.e., combined medication and behavioral treatment). Thereafter, children will be assessed monthly and treatment will be adjusted when response is inadequate. Outcome measures include child and family functioning, treatment satisfaction, and cost-benefit analysis.
Products: The expected outcomes from this study include:
Setting: The participants will come primarily from urban and suburban communities in Western New York.
Population: A total of 144 children between the ages of 6-12 with ADHD will participate. It is expected that approximately 10% of the referrals will be girls. Treatment will take place in general education classrooms. Exclusionary criteria include (1) children with Full Scale IQ below 70, (2) children with a history of seizures or other neurological problems and/or taking medication to prevent seizures, (3) children with a history of other medical problems for whom psychostimulant treatment may involve considerable risk, (4) children with a childhood history or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder; (5) children who do not exhibit functional impairment; and (6) children who are currently in special education.
Intervention: Treatment is at the student level where students are randomized to 1 of 2 adaptive treatment strategies: (1) Low dose stimulant medication or (2) School-based behavioral intervention (e.g., daily report card and supporting parent education). Children who are inadequate responders to their assigned treatment strategy will be further randomized to either (a) augment the initial treatment (e.g., increase dose of medication, add higher-intensity behavioral treatment) or (b) move to a combined treatment by adding the other treatment component.
Research Design and Methods: A randomized group design will be used with students as the unit of randomization; three sequential cohorts will be recruited. Most study measures will be conducted at pre-, post-, and follow-up, with monthly behavior ratings completed by parents and teachers as a way to measure progress.
Control Condition: This is an adaptive treatment design, where students are randomized to one of two treatment groups, with further randomization for nonresponders. Comparisons will be made within and across treatment groups.
Key Measures: A number of instruments will be utilized to gather diagnostic and assessment information including parent and teacher ratings and narrative descriptions of the child, a clinical interview with the parents to obtain childhood educational and developmental history, measures of peer relations and classroom behavior ratings. Additionally, information regarding treatment acceptability, parental psychopathology, and use of behavioral techniques in the home and at school will be collected. Whenever the father is involved with the child, ratings will be collected from both the mother and father. Information about students' IQ and academic achievement will also be collected. Researchers are using primarily well-established standardized clinical and educational measures.
Data Analytic Strategy: Because analysis of adaptive treatments treats the entire treatment bundle as a whole, group comparisons will be performed according to typical group analysis. Moderators (previous treatment, SES, ethnicity, gender, age) and mediators (interim response to treatment, treatment dosing, parent or teacher characteristics, teacher/child relationship) will also be evaluated. Many hypotheses will be addressed using mixed model ANOVA to accommodate the interdependence that exists between measurements taken from the same subjects over time. A treatment cost-effectiveness analysis will also be conducted.
Journal article, monograph, or newsletter
Page, T.F., Pelham, W.E., III., Fabiano, G.A., Greiner, A.R., Gnagy, E.M., Hart, K., Coxe, S., Waxmonsky, J.G., Foster, E.M., and Pelham, W.E., Jr. (2016). Comparative Cost Analysis of Sequential, Adaptive, Behavioral, Pharmacological, and Combined Treatments for Childhood ADHD. Journal of Clinical Child and Adolescent Psychology, 45(4): 1–12. doi:10.1080/15374416.2015.1055859
Pelham, W.E., Jr., Fabiano, G.A., Waxmonsky, J.G., Greiner, A.R., Gnagy, E.M., Pelham, W.E., III., Coxe, S., Verley, J., Bhatia, I., Hart, K., Karch, K., Konijnendijk, E., Tresco, K., Nahum-Shani, I., and Murphy, S.A. (2016). Treatment Sequencing for Childhood ADHD: A Multiple-Randomization Study of Adaptive Medication and Behavioral Interventions. Journal of Clinical Child and Adolescent Psychology, 45(4): 396–415. doi:10.1080/15374416.2015.1105138