Abstract
BackgroundThis 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.MethodsTwo 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.DiscussionMore 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 registrationClinicalTrials.gov NCT03437772. Registered on February 19, 2018. Sponsor number: PHRC-N/2016/JLC-01. RCB identification: 2017-A01349-44
Highlights
Background and rationale {6a} Attention deficit and hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by abnormally elevated levels of inattention, impulsivity, and hyperactivity that cause functional impairment in the personal and socio-professional domains
All persons qualifying as authors according to the International Committee of Medical Journal Editors (ICMJE) will be asked to sign an authorship contract. This project is designed to test an enhanced psychotherapy for children/adolescents with ADHD
Despite the high prevalence of this disorder in childhood, most research has focused on drug treatments since the latter have shown higher efficacy in decreasing ADHD symptoms
Summary
Background and rationale {6a} Attention deficit and hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by abnormally elevated levels of inattention, impulsivity, and hyperactivity that cause functional impairment in the personal and socio-professional domains. According to a review gathering information from 103 studies across the globe, ADHD, as defined by the International Classification of Diseases (ICD-10), is present in about. Apart from the behavioral and attentional problems that it causes, children and adolescents with ADHD have been qualified as socially disadvantaged, reporting low self-esteem and deficits in emotional and behavioral regulation [2]. In their adulthood, ADHD children present an increased risk of educational failure, unemployment, mental disorders, car accidents, substance abuse, interpersonal problems, and law-breaking behaviors [6, 7, 9, 18]. 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
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