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CBT Group for Adolescents With ADHD: a Randomized Controlled Trial

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02172183
Collaborator
(none)
119
Enrollment
1
Location
2
Arms
25
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Psychopharmacological treatment
  • Behavioral: CBT group
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
119 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Group Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: a Randomized Multicenter Controlled Trial
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Post-treatment ADHD symptoms [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.

  2. Post-treatment functional impairment [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 Outcome Measures

  1. Post-treatment depression symptoms [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)

  2. Post-treatment anxiety symptoms [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".

  3. Post-treatment anger management [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitari Vall d'Hebron Barcelona Spain 08035

Sponsors and Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Raquel Vidal, PhD, Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT02172183
Other Study ID Numbers:
  • CBT-RV
First Posted:
Jun 24, 2014
Last Update Posted:
Jun 24, 2014
Last Verified:
Jun 1, 2014
Keywords provided by Raquel Vidal, PhD, Hospital Universitari Vall d'Hebron Research Institute
cognitive-behavioral therapy, adolescents, ADHD.
Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Jun 24, 2014