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Completed

NCT Number: NCT02172183

CBT Group for Adolescents With ADHD: a Randomized Controlled Trial

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

15 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychopharmacological treatment

Drug

methylphenidate or atomoxetine

CBT group

Behavioral

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

  2. 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".

  3. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Group Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: a Randomized Multicenter Controlled Trial

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2014
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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