CBT Group for Adolescents With ADHD: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Psychopharmacological treatment
* Behavioral: CBT group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT group<br>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<br> <br> |
| Active Comparator: Psychopharmacological treatment<br>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<br>* methylphenidate or atomoxetine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive-behavioral therapy, adolescents, ADHD.