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Clinical Trials/NCT02172183
NCT02172183
Completed
Not Applicable

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

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country119 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
CBT group
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
119
Locations
1
Primary Endpoint
Post-treatment ADHD symptoms
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
May 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raquel Vidal

PhD

Hospital Universitari Vall d'Hebron Research Institute

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: CBT group

Psychopharmacological treatment

Participants were only visited to monitor their adherence and continuation on medications for ADHD (methylphenidate or atomoxetine) as prescribed by their psychiatrist.

Intervention: Psychopharmacological treatment

Outcomes

Primary Outcomes

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 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.

Secondary Outcomes

  • Post-treatment anger management(Post-treatment (after receiving 3 month treatment))
  • Post-treatment anxiety symptoms(Post-treatment (after receiving 3 month treatment))
  • Post-treatment depression symptoms(Post-treatment (after receiving 3 month treatment))

Study Sites (1)

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