CBT Group for Adolescents With ADHD: a Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: CBT group; Drug: Psychopharmacological treatment

• Registration Number: NCT02172183
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2014-06
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-24
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT group	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.
Psychopharmacological treatment	Psychopharmacological treatment	Participants were only visited to monitor their adherence and continuation on medications for ADHD (methylphenidate or atomoxetine) as prescribed by their psychiatrist.

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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
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)
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".

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain