Effectiveness of a positive psychology and mindfulness-based app on mental health for parents of children with a neurodevelopmental disorder: study protocol of a pragmatic international randomized controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Mindfulness*/methods ; Parents*/psychology ; Mental Health* ; Neurodevelopmental Disorders*/psychology ; Neurodevelopmental Disorders*/therapy ; Pragmatic Clinical Trials as Topic* ; Multicenter Studies as Topic* ; Mobile Applications*; Humans ; Child ; Psychology, Positive/methods ; Adolescent ; Stress, Psychological/therapy ; Stress, Psychological/psychology ; Treatment Outcome ; Adaptation, Psychological ; Randomized Controlled Trials as Topic

Introduction: Parents of children with a neurodevelopmental disorder (NDD) experience more stress than parents of typically developing children. In a cocreation process with experts and parents, a low-threshold application that uses exercises based on the principles of positive psychology and mindfulness was developed. This application, called "Adappt," aims at enhancing the ability to adapt of the parents and caregivers of children with NDDs and at supporting their mental health. This protocol describes the evaluation study of the effectiveness of Adappt, its core working mechanisms and user experiences.
Method: A pragmatic international multicenter randomized controlled trial will compare the effectiveness of Adappt with a (delayed) waitlist control condition. At least 212 parents or primary caregivers of children younger than 18 years diagnosed with or suspected of a NDD will be randomly assigned to the intervention or waitlist control condition. Participants are excluded if they have severe anxiety or depression levels or are in treatment for mental health issues. Measures will be collected online at baseline, post-intervention (1 month after baseline), and 4 and 7 months after baseline. The primary outcome is the improvement in generic sense of ability to adapt as measured with the Generic Sense of Ability to Adapt Scale (GSAAS; (Front Psychol 14:985408, 2023)) at 4-month follow-up. Secondary outcomes are mental well-being, (parental) distress, and client satisfaction with "Adappt."
Discussion: Results of this study will contribute to knowledge on the effectiveness of a low-threshold application for parents of children with a NDD in multiple countries. If the application is found to be effective in improving mental health, recommendations will be made for implementation in health care.
Trial Registration: This study is registered on clinicaltrials.gov (NCT06248762) on February 8, 2024, and the Open Science Framework ( https://osf.io/5znqv ).
(© 2024. The Author(s).)

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101057385 HORIZON EUROPE Framework Programme

Keywords: ADHD; Ability to adapt; Adappt; Application; Autism; Digital intervention; Effectiveness; Neurodevelopmental disorder; Parents; RCT; Randomized controlled trial; Self-help; Well-being

ClinicalTrials.gov NCT06248762

Date Created: 20240626 Date Completed: 20240627 Latest Revision: 20240828

20240828

PMC11210113

10.1186/s13063-024-08256-w

38926739