CBT Group for Adolescents With ADHD: a Randomized Controlled Trial

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172183
• Other study ID #: CBT-RV
• Status: Completed
• Phase: N/A
• First received: June 18, 2014
• Last updated: June 20, 2014
• Start date: April 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 21 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Psychopharmacological treatment
methylphenidate or atomoxetine

Behavioral:
• CBT group

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-treatment ADHD symptoms	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)	No
Primary	Post-treatment functional impairment	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)	No
Secondary	Post-treatment depression symptoms	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)	No
Secondary	Post-treatment anxiety symptoms	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)	No
Secondary	Post-treatment anger management	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)	No