CBT Group for Adolescents With ADHD: a Randomized Controlled Trial
|ClinicalTrials.gov Identifier: NCT02172183|
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
|Condition or disease||Intervention/treatment|
|Attention Deficit Hyperactivity Disorder||Drug: Psychopharmacological treatment Behavioral: CBT group|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Group Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: a Randomized Multicenter Controlled Trial|
|Study Start Date :||April 2012|
|Primary Completion Date :||March 2014|
|Study Completion Date :||May 2014|
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
- Post-treatment ADHD symptoms [ Time Frame: 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 [ Time Frame: 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.
- Post-treatment depression symptoms [ Time Frame: 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 [ Time Frame: 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".
- Post-treatment anger management [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172183
|Hospital Universitari Vall d'Hebron|
|Barcelona, Spain, 08035|
|Principal Investigator:||Raquel Vidal, PhD||Hospital Vall d'Hebron|