CBT Group for Adolescents With ADHD: a Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raquel Vidal, Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT02172183
First received: June 18, 2014
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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 Intervention
Attention Deficit Hyperactivity Disorder
Drug: Psychopharmacological treatment
Behavioral: CBT group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Group Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: a Randomized Multicenter Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Post-treatment ADHD symptoms [ Time Frame: Post-treatment (after receiving 3 month treatment) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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:
  • Post-treatment depression symptoms [ Time Frame: Post-treatment (after receiving 3 month treatment) ] [ Designated as safety issue: No ]
    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 anxiety symptoms [ Time Frame: Post-treatment (after receiving 3 month treatment) ] [ Designated as safety issue: No ]
    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 anger management [ Time Frame: Post-treatment (after receiving 3 month treatment) ] [ Designated as safety issue: No ]
    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


Enrollment: 119
Study Start Date: April 2012
Study Completion Date: May 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02172183

Locations
Spain
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 Universitari Vall d'Hebron
  More Information

No publications provided

Responsible Party: Raquel Vidal, PhD, Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02172183     History of Changes
Other Study ID Numbers: CBT-RV
Study First Received: June 18, 2014
Last Updated: June 20, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
cognitive-behavioral therapy, adolescents, ADHD.

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014