CBT Group for Adolescents With ADHD: a Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT02172183|
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Psychopharmacological treatment Behavioral: CBT group||Not Applicable|
|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|
|Actual Primary Completion Date :||March 2014|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|