NCT02172183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

June 18, 2014

Last Update Submit

June 20, 2014

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

cognitive-behavioral therapy, adolescents, ADHD.

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Post-treatment depression symptoms

    Post-treatment (after receiving 3 month treatment)

  • Post-treatment anxiety symptoms

    Post-treatment (after receiving 3 month treatment)

  • Post-treatment anger management

    Post-treatment (after receiving 3 month treatment)

Study Arms (2)

CBT group

EXPERIMENTAL

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

Psychopharmacological treatment

ACTIVE COMPARATOR

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

Interventions

Psychopharmacological treatmentDRUG

methylphenidate or atomoxetine

Psychopharmacological treatment
CBT groupBEHAVIORAL
CBT group

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25791144DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Raquel Vidal, PhD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 24, 2014

Study Start

April 1, 2012

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

ES(1)