Third-generation cognitive behavioral therapy versus treatment-as-usual for attention deficit and hyperactivity disorder: a multicenter randomized controlled trial

BACKGROUND: This study aims to compare improvements in attention deficit and hyperactivity disorder (ADHD) symptom severity between a group of ADHD children and parents undergoing a new therapeutic program based on third-generation cognitive behavioral therapy (Hyper-mCBT) and a similar group undergoing treatment-as-usual with the Barkley program. METHODS: Two hundred forty-eight children diagnosed with ADHD will be randomly assigned to either a Hyper-mCBT program or a Barkley program. This is a multicenter randomized (1:1), 2 parallel-group, superiority trial with evaluator blinding and stratification according to center and methylphenidate treatment. The Hyper-mCBT program consists in a series of 16 simultaneous-but-separate therapy sessions for parents and for children. DISCUSSION: More effective psychotherapeutic approaches are needed for ADHD children. Pharmacotherapy seems to be more effective in reducing ADHD symptoms but it is not always helpful, it carries side effects, and it is rejected by many parents/professionals. Results for psychotherapy programs for ADHD are inconsistent although several studies have shown clinical improvements. This trial will substantiate encouraging preliminary results of an innovative psychotherapy program for both parents and children. TRIAL REGISTRATION: ClinicalTrials.gov NCT03437772. Registered on February 19, 2018. Sponsor number: PHRC-N/2016/JLC-01. RCB identification: 2017-A01349-44 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05983-2.