Skills Training for Adolescents With ADHD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
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

November 20, 2009
May 24, 2012
October 2009
November 2012   (final data collection date for primary outcome measure)
changes in ADHD Symptoms [ Time Frame: Measured before randomization, 4 Months, and 8 Months ] [ Designated as safety issue: No ]
ADHD Symptoms [ Time Frame: Measured before randomization, 4 Months, and 8 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01019252 on ClinicalTrials.gov Archive Site
changes in Secondary symptoms of ADHD (e.g., mood) [ Time Frame: Measured before randomization, 4 months, and 8 months ] [ Designated as safety issue: No ]
Secondary symptoms of ADHD (e.g., mood) [ Time Frame: Measured before randomization, 4 months, and 8 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Skills Training for Adolescents With ADHD
Compensatory Executive Functioning Skills Training in Adolescents With ADHD

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
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
  • Experimental: Cognitive Behavioral Therapy
    Participants will receive Cognitive Behavioral Therapy following randomization.
    Intervention: Behavioral: Cognitive Behavioral Therapy (CBT)
  • 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.
    Intervention: Behavioral: Cognitive Behavioral Therapy (CBT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
14 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01019252
R34 MH083063, R34MH083063, DDTR B4-TBI
Yes
Steven A. Safren, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Steven A. Safren, Ph.D. Massachusetts General Hospital
Principal Investigator: Susan E Sprich, Ph.D. Massachusetts General Hospital
Massachusetts General Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP