Skills Training for Adolescents With ADHD
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Behavioral: Cognitive Behavioral Therapy (CBT) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Compensatory Executive Functioning Skills Training in Adolescents With ADHD |
- changes in ADHD Symptoms [ Time Frame: Measured before randomization, 4 Months, and 8 Months ] [ Designated as safety issue: No ]
- changes in Secondary symptoms of ADHD (e.g., mood) [ Time Frame: Measured before randomization, 4 months, and 8 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cognitive Behavioral Therapy
Participants will receive Cognitive Behavioral Therapy following randomization.
|
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
Other Name: Compensatory executive skills training
|
|
No Intervention: Wait List Control
Participants will be assigned to a wait list after the initial assessment. They will receive Cognitive Behavioral Therapy after the 4 month assessment.
|
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
Other Name: Compensatory executive skills training
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 14 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Steven A. Safren, Ph.D. | Massachusetts General Hospital |
| Principal Investigator: | Susan E Sprich, Ph.D. | Massachusetts General Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01019252 History of Changes |
| Other Study ID Numbers: | R34 MH083063, R34MH083063, DDTR B4-TBI |
| Study First Received: | November 20, 2009 |
| Last Updated: | May 24, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Massachusetts General Hospital:
|
Adolescent ADHD |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013