Clinical trial NCT02172183: 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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: cognitive-behavioral therapy, adolescents, ADHD.
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 119
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Post-treatment ADHD symptoms
timeFrame: Post-treatment (after receiving 3 month treatment)
measure: Post-treatment functional impairment
timeFrame: Post-treatment (after receiving 3 month treatment)
Secondary outcomes:
measure: Post-treatment depression symptoms
timeFrame: Post-treatment (after receiving 3 month treatment)
measure: Post-treatment anxiety symptoms
timeFrame: Post-treatment (after receiving 3 month treatment)
measure: Post-treatment anger management
timeFrame: Post-treatment (after receiving 3 month treatment)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Raquel Vidal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.