Skills Training for Adolescents With ADHD

NCT01019252 | Completed Results DMC

• 2 other identifiers: R34MH083063DDTR B4-TBI
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Adolescent; ADHD

Outcome Measures

Primary Outcomes (3)

• Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report

  -Independent blinded evaluator rated adolescent report of symptom severity (Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV). The independent evaluator administered the ADHD rating scale-IV to adolescent participants. This scale, updated for Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV), assesses each of 18 individual symptoms of ADHD using an identical four-point severity grid (0 = not present up to 3 = severe; minimum total score = 0, maximum total score =54, with higher scores indicating greater symptomatology). The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.

  before randomization, 4-months, 8-months

• Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating

  -Independent, blinded evaluator rating of ADHD symptom severity (Clinical Global Impressions - severity scale). The Clinical Global Impression (CGI) Scale is a widely used rating scale to measure overall severity related to ADHD symptoms. The Global Severity rating ranges from; 1=not ill, to 7= extremely ill, with higher scores indicating greater severity.The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.

  before randomization, 4-months, 8-months

• Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report

  -Independent blinded evaluator rated parent report of symptom severity (ADHD Rating Scale-IV) to the parent of the adolescent participant. This scale, updated for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), assesses each of 18 individual symptoms of ADHD using an identical four-point severity grid (0 = not present up to 3 = severe; minimum total score = 0, maximum total score =54, with higher scores indicating greater symptomatology). The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.

  baseline, 4-months, and 8-months

Study Arms (2)

CBT for ADHD first, then follow-up

EXPERIMENTAL

Participants received Cognitive Behavioral Therapy following randomization.

Behavioral: Cognitive Behavioral Therapy (CBT)

Wait list first, then CBT for ADHD

NO INTERVENTION

Cross-over: Participants were assigned to a wait list after the initial assessment. They received Cognitive Behavioral Therapy after the 4 month assessment.

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.

Also known as: Compensatory executive skills training

CBT for ADHD first, then follow-up

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Sprich SE, Safren SA, Finkelstein D, Remmert JE, Hammerness P. A randomized controlled trial of cognitive behavioral therapy for ADHD in medication-treated adolescents. J Child Psychol Psychiatry. 2016 Nov;57(11):1218-1226. doi: 10.1111/jcpp.12549. Epub 2016 Mar 17.

  PMID: 26990084 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

* Initial efficacy trial leading to small sample size * Sample was restricted to stably medicated adolescents * Did not use a time-matched, attention-matched control

Results Point of Contact

• Title: Susan Sprich, Ph.D.
• Organization: Massachusetts General Hospital

ssprich@mgh.harvard.edu

617-726-5991

Study Officials

• Steven A. Safren, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

• Susan E Sprich, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Behavioral Medicine

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 25, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 31, 2018
• Results First Posted: July 31, 2018

Record last verified: 2018-07

Locations

US (1)