CBT Group for Adolescents With ADHD: a Randomized Controlled Trial

NCT ID: NCT02172183

Last Updated: 2014-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Hyperactivity Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

CBT group

Intervention Type BEHAVIORAL

Psychopharmacological treatment

Participants were only visited to monitor their adherence and continuation on medications for ADHD (methylphenidate or atomoxetine) as prescribed by their psychiatrist.

Group Type ACTIVE_COMPARATOR

Psychopharmacological treatment

Intervention Type DRUG

methylphenidate or atomoxetine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psychopharmacological treatment

methylphenidate or atomoxetine

Intervention Type DRUG

CBT group

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Raquel Vidal

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raquel Vidal, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25791144 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CBT-RV

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CBT-I in Adolescents With ADHD
NCT07209969 ACTIVE_NOT_RECRUITING NA
Cognitive Training Trial
NCT01133418 COMPLETED NA