Cognitive-behavioural group therapy for adolescents with ADHD: study protocol for a randomised controlled trial.

Introduction: Persistence of attention deficit hyperactivity disorder (ADHD) into adolescence is a significant burden to patients. Clinical guidelines recommend non-pharmacological therapies, but the evidence to support this recommendation is sparse. This study aims to evaluate the effect of a 12-week group cognitive-behavioural therapy (CBT) programme for adolescents with ADHD aged 14-18 years, who still have impairing symptoms after treatment with medication. We will study the effect of the treatment on ADHD symptoms and examine moderators and mediators of the effect of the treatment on ADHD.
Methods and Analysis: We conduct a randomised controlled trial of CBT group therapy in adolescents with ADHD recruited from child psychiatric outpatient units in Mid-Norway. 99 adolescents who met inclusion criteria and consented to participation have been randomised to a 12-week group intervention or to a control group receiving treatment as usual. Assessments are made at admission to the clinic, preintervention, postintervention and at a 9-month follow-up, obtaining adolescent, parent and teacher reports. Clinicians blinded to group allocation rate all participants as to their functioning preintervention and at the two postintervention assessment points. The primary outcome is change in symptom scores on the ADHD Rating Scale-IV.
Ethics and Dissemination: The Regional Committee for Medical and Health Research Ethics in South East Norway approved the study protocol (2015/2115). We will disseminate the findings in peer-reviewed publications and conference presentations, to user organisations and at courses attended by families and professionals. Two PhD students will publish and defend dissertations relating to the study. Planned publications include primary and secondary outcomes and patient satisfaction with the treatment. Furthermore, we plan to publish a manual of CBT group therapy in adolescent ADHD to benefit treatment of patients in Norway and elsewhere.
Trial Registration Number: NCT02937142.
Competing Interests: Competing interests: TSN has received a speaker’s fee from Medice in the last year. PHT has received speaker’s fees from MEDICE and Shire in the last 3 years. SY has received honoraria for consultation and/or educational talks in the last 5 years from Janssen, HB Pharma and/or Shire. She is author of the 'ADHD Child Evaluation (ACE) and ACE+ (for adults)' and lead author of 'R&R2 for ADHD Youths and Adults'. AMS has received travel support and congress fee from MEDICE in the last year.
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