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Skills Training for Adolescents With ADHD

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ClinicalTrials.gov Identifier: NCT01019252
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
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) Not Applicable

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)
Actual Enrollment : 66 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
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBT for ADHD first, then follow-up
Participants received 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 first, then CBT for ADHD
Cross-over: Participants were assigned to a wait list after the initial assessment. They received Cognitive Behavioral Therapy after the 4 month assessment.



Primary Outcome Measures :
  1. Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report [ Time Frame: before randomization, 4-months, 8-months ]
    -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.

  2. Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating [ Time Frame: before randomization, 4-months, 8-months ]
    -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.

  3. Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report [ Time Frame: baseline, 4-months, and 8-months ]
    -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.



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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. University of Miami
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 )
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
Results First Posted: July 31, 2018
Last Update Posted: July 31, 2018
Last Verified: July 2018

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