Overview

This trial is active, not recruiting.

Condition attention deficit hyperactivity disorder
Treatment cognitive behavioral therapy (cbt)
Phase phase 1/phase 2
Sponsor Massachusetts General Hospital
Collaborator National Institute of Mental Health (NIMH)
Start date October 2009
End date November 2012
Trial size 50 participants
Trial identifier NCT01019252, DDTR B4-TBI, R34 MH083063, R34MH083063

Summary

The proposed study will be an initial test of a cognitive-behavioral intervention for adolescents with ADHD who are receiving medication treatment. It is based on our successful work with adults with ADHD who have been treated with medicines but are still having symptoms. It involves learning skills for organization and planning, attention, and mood.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will receive Cognitive Behavioral Therapy following randomization.
cognitive behavioral therapy (cbt) Compensatory executive skills training
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
(No Intervention)
Participants will be assigned to a wait list after the initial assessment. They will receive Cognitive Behavioral Therapy after the 4 month assessment.
cognitive behavioral therapy (cbt) Compensatory executive skills training
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.

Primary Outcomes

Measure
changes in ADHD Symptoms
time frame: Measured before randomization, 4 Months, and 8 Months

Secondary Outcomes

Measure
changes in Secondary symptoms of ADHD (e.g., mood)
time frame: Measured before randomization, 4 months, and 8 months

Eligibility Criteria

Male or female participants from 14 years up to 18 years old.

Inclusion Criteria: - Between the ages of 14 and 18 - In high school - Principal Diagnosis of ADHD - Stable prescription of Medications for ADHD - ADHD has childhood onset - Clinically significant ADHD symptoms Exclusion Criteria: - Organic Mental Disorders - Active Substance Abuse or Dependence - Diagnosis of Conduct Disorder - Mental Retardation or Pervasive Developmental Disorder - Active Suicidality - Previous History of CBT Therapy in adolescence - Other condition interfering with consent or participation

Additional Information

Official title Compensatory Executive Functioning Skills Training in Adolescents With ADHD
Principal investigator Steven A. Safren, Ph.D.
Description Attention Deficit Hyperactivity Disorder (ADHD) is a prevalent, distressing, and interfering condition that affects between 2% and 6% of adolescents. Although medications have been widely used as an effective treatment for many years as the sole treatment for ADHD, for many, clinically significant and interfering continued symptoms remain. Even after medication treatment, adolescents still experience residual ADHD symptoms and continue to have problems with inattention, concentration, disorganization, and other symptoms. However, research suggests that adolescents who have received some benefit from medication treatment can then experience further symptom reduction from participation in skills-based cognitive behavioral therapy. This study, adapted from a similar research study for adults with ADHD, will examine whether cognitive behavioral therapy (CBT) plus medication is more effective at treating ADHD than medication therapy alone in adolescents with ADHD. Eligible participants will be randomly assigned to receive twelve weekly treatment sessions either immediately upon enrolling in the study or after a four-month waiting period. Questionnaires (that participants complete and ones that are done with an interviewer) will be used to assess participants' ADHD symptoms at study entry, after receiving the treatment, and at 4 month follow-up. Parents will have some involvement in therapy. Note: participants must be able to come to Boston or another study location in the Greater Boston area for 4 assessment visits and 12 weekly therapy visits in order for participation to be feasible.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.