CBT Group for Adolescents With ADHD: a Randomized Controlled Trial

June 20, 2014 updated by: Raquel Vidal, Hospital Universitari Vall d'Hebron Research Institute

Group Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: a Randomized Multicenter Controlled Trial

This is the first randomized controlled study that tests the efficacy of a cognitive-behavioral group therapy (CBT) on adolescents with ADHD who were in pharmacological treatment but still presented persistent symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multicenter, randomized rater-blinded controlled trial was carried out in a sample of 119 adolescents (15-21 years) and was conducted between April 2012- May 2014. Patients were randomly assigned to 12 group manualized cognitive-behavioural group therapy sessions (n=45) or a waiting list control group (N=44). Primary outcomes were assessed by a blind evaluator (ADHD Rating Scale, Clinical Global Impression Scale for Severity, Global Assessment Functioning) before and after treatment as well as by self-report and parent informant ratings.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV ADHD diagnosis
  • age between 15 and 21 years
  • stabilized doses of medication for ADHD for at least 2 months prior to the study
  • agreement not to seek out any other psychiatric or psychological treatment during the study.

Exclusion Criteria:

  • affective disorders
  • anxiety disorders
  • psychotic disorders
  • personality disorders
  • substance use disorders in the past 6 months
  • pervasive developmental disorder
  • patients with an IQ lower than 85
  • patients receiving concurrent psychological interventions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT group
This group consist on a combined intervention: CBT group + psychopharmacological treatment. The group program was based on cognitive-behavioral principles and also motivational interviewing techniques to facilitate skills implementation. The treatment comprised 12 manualized sessions with an inattention module and an impulsivity module.
Behavioral: CBT group
Active Comparator: Psychopharmacological treatment
Participants were only visited to monitor their adherence and continuation on medications for ADHD (methylphenidate or atomoxetine) as prescribed by their psychiatrist.
Drug: Psychopharmacological treatment
methylphenidate or atomoxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-treatment ADHD symptoms
Time Frame: Post-treatment (after receiving 3 month treatment)
measured by ADHD Rating Scale (clinician-administered version for the adolescent and also parent informant). It is a 18 item scale which assesses the diagnostic criteria for ADHD and rates the frequency of each item on a 4 point Likert scale.
Post-treatment (after receiving 3 month treatment)
Post-treatment functional impairment
Time Frame: Post-treatment (after receiving 3 month treatment)
Assessed by Weiss Functional Impairment Scale (WFIRS) self report and parent version (an appropriate measure for functional impairment associated with ADHD) and by GAF (Global Assessment of Functioning) evaluated by a blinded rater. It is a clinician-administered measure to assess clinical severity and functioning.
Post-treatment (after receiving 3 month treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-treatment depression symptoms
Time Frame: Post-treatment (after receiving 3 month treatment)
assessed by Beck Inventory Depression Scale (BDI). It is a 21 item scale to test depression symptoms where respondents rate how they have been feeling during the past week on a 4 point Likert scale (0-3)
Post-treatment (after receiving 3 month treatment)
Post-treatment anxiety symptoms
Time Frame: Post-treatment (after receiving 3 month treatment)
assessed by State-Trait Anxiety Inventory. It is a 40 item scale. It differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety".
Post-treatment (after receiving 3 month treatment)
Post-treatment anger management
Time Frame: Post-treatment (after receiving 3 month treatment)
State-Trait Anger Expression Inventory-2 (STAXI-2)was used for patients between 16-21 years and STAXI-NA for 15 years-old patients. The STAXI-2 is a self-report questionnaire that measures state anger, trait anger, expression and control of anger
Post-treatment (after receiving 3 month treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Raquel Vidal, PhD, Hospital Vall d'Hebron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 20, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBT-RV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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