积极心理学和正念为基础的应用程序对发育障碍儿童父母心理健康的有效性：实用国际随机对照试验的研究方案。
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.
机构信息
Faculty of Behavioural, Management and Social Sciences, Section of Psychology, Health and Technology, University of Twente, 217 , Enschede, The Netherlands.
Department of Psychiatry, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
出版信息
Trials. 2024 Jun 26;25(1):412. doi: 10.1186/s13063-024-08256-w.
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 ).
简介
与发育障碍（NDD）儿童的父母相比，发育正常儿童的父母经历了更多的压力。在与专家和家长共同创作的过程中，开发了一种基于积极心理学和正念原则的练习的低门槛应用程序，称为“Adappt”。该应用程序旨在提高 NDD 儿童的父母和照顾者的适应能力，并支持他们的心理健康。本方案描述了 Adappt 的有效性评估研究、其核心工作机制和用户体验。
方法
一项实用的国际多中心随机对照试验将比较 Adappt 的有效性与（延迟）候补名单对照条件。将随机分配至少 212 名年龄在 18 岁以下、被诊断为或疑似患有 NDD 的儿童的父母或主要照顾者到干预组或候补名单对照组。如果参与者有严重的焦虑或抑郁水平，或正在接受心理健康问题的治疗，则将其排除在外。在基线、干预后（基线后 1 个月）以及基线后 4 个月和 7 个月时在线收集测量结果。主要结果是在 4 个月随访时使用通用适应能力量表（GSAAS；（Front Psychol 14:985408, 2023））测量的通用适应能力改善情况。次要结果是心理健康、（父母）痛苦和对“Adappt”的客户满意度。
讨论
这项研究的结果将有助于了解针对多个国家 NDD 儿童父母的低门槛应用程序的有效性。如果该应用程序被证明在改善心理健康方面有效，将提出在医疗保健中实施的建议。
试验注册
该研究于 2024 年 2 月 8 日在 clinicaltrials.gov（NCT06248762）上注册，并在开放科学框架（https://osf.io/5znqv）上注册。
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