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Skills Training for Adolescents With ADHD

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ClinicalTrials.gov Identifier: NCT01019252
Recruitment Status : Unknown
Verified May 2012 by Steven A. Safren, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2009
Last Update Posted : May 25, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Steven A. Safren, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Cognitive Behavioral Therapy (CBT) Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compensatory Executive Functioning Skills Training in Adolescents With ADHD
Study Start Date : October 2009
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. changes in ADHD Symptoms [ Time Frame: Measured before randomization, 4 Months, and 8 Months ]

Secondary Outcome Measures :
  1. changes in Secondary symptoms of ADHD (e.g., mood) [ Time Frame: Measured before randomization, 4 months, and 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019252


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Steven A. Safren, Ph.D. Massachusetts General Hospital
Principal Investigator: Susan E Sprich, Ph.D. Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01019252     History of Changes
Other Study ID Numbers: R34MH083063 ( U.S. NIH Grant/Contract )
DDTR B4-TBI ( Other Grant/Funding Number: National Institute of Mental Health )
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012

Keywords provided by Steven A. Safren, Massachusetts General Hospital:
Adolescent
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders