Back to resultsCBT Group for Adolescents With ADHD: a Randomized Controlled Trial
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychopharmacological treatment
CBT group
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring cognitive-behavioral therapy, adolescents, ADHD.
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitari Vall d'Hebron
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT group
Psychopharmacological treatment
Arm Description
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.
Participants were only visited to monitor their adherence and continuation on medications for ADHD (methylphenidate or atomoxetine) as prescribed by their psychiatrist.
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
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 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 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
Full Information
NCT ID
NCT02172183
First Posted
June 18, 2014
Last Updated
June 20, 2014
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02172183
Brief Title
CBT Group for Adolescents With ADHD: a Randomized Controlled Trial
Official Title
Group Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: a Randomized Multicenter Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
cognitive-behavioral therapy, adolescents, ADHD.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT group
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychopharmacological treatment
Arm Type
Active Comparator
Arm Description
Participants were only visited to monitor their adherence and continuation on medications for ADHD (methylphenidate or atomoxetine) as prescribed by their psychiatrist.
Intervention Type
Drug
Intervention Name(s)
Psychopharmacological treatment
Intervention Description
methylphenidate or atomoxetine
Intervention Type
Behavioral
Intervention Name(s)
CBT group
Primary Outcome Measure Information:
Title
Post-treatment ADHD symptoms
Description
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.
Time Frame
Post-treatment (after receiving 3 month treatment)
Title
Post-treatment functional impairment
Description
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.
Time Frame
Post-treatment (after receiving 3 month treatment)
Secondary Outcome Measure Information:
Title
Post-treatment depression symptoms
Description
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)
Time Frame
Post-treatment (after receiving 3 month treatment)
Title
Post-treatment anxiety symptoms
Description
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".
Time Frame
Post-treatment (after receiving 3 month treatment)
Title
Post-treatment anger management
Description
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
Time Frame
Post-treatment (after receiving 3 month treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Vidal, PhD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25791144
Citation
Vidal R, Castells J, Richarte V, Palomar G, Garcia M, Nicolau R, Lazaro L, Casas M, Ramos-Quiroga JA. Group therapy for adolescents with attention-deficit/hyperactivity disorder: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2015 Apr;54(4):275-82. doi: 10.1016/j.jaac.2014.12.016. Epub 2015 Jan 26. Erratum In: J Am Acad Child Adolesc Psychiatry. 2017 Nov;56(11):1000-1001.
Results Reference
derived
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CBT Group for Adolescents With ADHD: a Randomized Controlled Trial
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