Skills Training for Adolescents With ADHD

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven A. Safren, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01019252
First received: November 20, 2009
Last updated: May 24, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • changes in ADHD Symptoms [ Time Frame: Measured before randomization, 4 Months, and 8 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019252

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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 April 16, 2014