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Skills Training for Adolescents With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Adolescent, ADHD

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBT for ADHD first, then follow-up

Wait list first, then CBT for ADHD

Arm Description

Participants received Cognitive Behavioral Therapy following randomization.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2009
Last Updated
July 2, 2018
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01019252
Brief Title
Skills Training for Adolescents With ADHD
Official Title
Compensatory Executive Functioning Skills Training in Adolescents With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Adolescent, ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT for ADHD first, then follow-up
Arm Type
Experimental
Arm Description
Participants received Cognitive Behavioral Therapy following randomization.
Arm Title
Wait list first, then CBT for ADHD
Arm Type
No Intervention
Arm Description
Cross-over: Participants were assigned to a wait list after the initial assessment. They received Cognitive Behavioral Therapy after the 4 month assessment.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Other Intervention Name(s)
Compensatory executive skills training
Intervention Description
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
Primary Outcome Measure Information:
Title
Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report
Description
-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.
Time Frame
before randomization, 4-months, 8-months
Title
Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating
Description
-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.
Time Frame
before randomization, 4-months, 8-months
Title
Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report
Description
-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.
Time Frame
baseline, 4-months, and 8-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A. Safren, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan E Sprich, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26990084
Citation
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.
Results Reference
derived

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Skills Training for Adolescents With ADHD

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