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. 2024 Jun 26;25(1):412.
doi: 10.1186/s13063-024-08256-w.

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

Kim J M Tönis  1 , Constance H C Drossaert  2 , Peter M Ten Klooster  2 , Marie Schaer  3 , Thomas Bourgeron  4 , Jan K Buitelaar  5   6 , Yair Sadaka  7 , Christine M Freitag  8 , Keren Mayer Lapidus  9 , Andreas G Chiocchetti  8 , Wouter G Staal  5   10   6 , Ernst T Bohlmeijer  2
Affiliations

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

Kim J M Tönis et al. Trials. .

Abstract

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 ).

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

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of participants
Fig. 2
Fig. 2
Procedure schedule. Note. * A more detailed overview of outcome measures and questionnaires can be found in Table 2. Adapted from Spirit (n.d.). Publications and Downloads. https://spirit-statement.org/publications-downloads/
See this image and copyright information in PMC

References

    1. American Psychiatric Association. Neurodevelopmental disorders: DSM-5® selections [Google Books]. Arlington: American Psychiatric Association Pub; 2016.
    1. Ames JL, Ladd-Acosta C, Fallin MD, Qian Y, Schieve LA, DiGuiseppi C, Lee LC, Kasten EP, Zhou G, Pinto-Martin J, Howerton EM, Eaton CL, Croen LA. Maternal psychiatric conditions, treatment with selective serotonin reuptake inhibitors, and neurodevelopmental disorders. Biol Psychiatry. 2021;90(4):253–262. doi: 10.1016/j.biopsych.2021.04.002. - DOI - PMC - PubMed
    1. Assaz DA, Roche B, Kanter JW, Oshiro CKB. Cognitive defusion in acceptance and commitment therapy: what are the basic processes of change? Psychol Record. 2018;68(4):405–418. doi: 10.1007/s40732-017-0254-z. - DOI
    1. Attkisson CC, Zwick R. The client satisfaction questionnaire: psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233–237. doi: 10.1016/0149-7189(82)90074-X. - DOI - PubMed
    1. Belli A, Breda M, Di Maggio C, Esposito D, Marcucci L, Bruni O. Children with neurodevelopmental disorders: how do they sleep? Curr Opin Psychiatry. 2022;35(5):345–351. doi: 10.1097/YCO.0000000000000790. - DOI - PubMed

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