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Completed

NCT Number: NCT01019252

Skills Training for 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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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

Other names: Compensatory executive skills training

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Compensatory Executive Functioning Skills Training in Adolescents With ADHD

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 25, 2009
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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