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数字家庭作业支持计划对注意缺陷多动障碍儿童和青少年的作用:一项随机对照试验方案。

Digital Homework Support Program for Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: Protocol for a Randomized Controlled Trial.

机构信息

University of Nantes, Nantes, France.

Centre Hopsitalo-Universitaire of Nantes, Nantes, France.

出版信息

JMIR Res Protoc. 2024 Nov 21;13:e44553. doi: 10.2196/44553.

DOI:10.2196/44553
PMID:39571155
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11621713/
Abstract

BACKGROUND

Attention-deficit/hyperactivity disorder (ADHD) affects 4% to 5% of the general population. Homework sessions are frequent conflictual moments characterized by increased anxiety in children and stress in their parents, contributing to a lower family quality of life. Children with ADHD experience more severe homework problems than typically developing peers. Poor academic performance in individuals with ADHD is partly attributed to challenging homework. Psychoeducational and school-based approaches are time-consuming and not fully accessible to professionals. Digital tools, such as smartphone and tablet apps, might offer an interesting alternative. We present our digital homework support program for children and adolescents, known as "Programme d'Aide Numérique aux Devoirs pour Enfant avec TDA-H" (PANDAH), along with the study protocol of our ongoing randomized controlled trial.

OBJECTIVE

This study aims to test PANDAH's efficacy in improving homework performance and family quality of life.

METHODS

Individuals aged 9-16 years with an ADHD diagnosis and no comorbid psychiatric disorders are included. This is a multicenter study involving 9 reference centers for ADHD in France. The study comprises (1) a 3-month period with a randomized controlled trial design, where participants are divided into 2 parallel groups (group 1: care as usual or waiting list; group 2: PANDAH app), followed by (2) an extension period of 3 months (months 3-6), during which all participants will have access to the app. This second phase serves as a crucial incentive for patients initially randomly assigned to group 1. Assessments will be conducted at baseline, month 3, and month 6 for each patient by trained psychologists. The primary end point will be the global Homework Performance Questionnaire (HPQ), Parent version score at 6 months. The main analysis will adhere to the "intent-to-treat principle" (all patient data will be analyzed according to their initial group determined by randomization). We expect (1) HPQ score improvement in individuals using the app during the first 3-month period compared to individuals not using the app; (2) greater HPQ score improvement for individuals using the app for 6 months compared to those using the app for 3 months only; and (3) adherence to the PANDAH program, measured with in-app metrics.

RESULTS

Recruitment began in January 2024, and the trial is ongoing.

CONCLUSIONS

This study contributes to the digital transformation of health care. The use of smartphone apps in self-care and self-management is a societal phenomenon, and its implementation in the field of psychiatry is of particular interest. The app might serve as both valuable support for patients and an opportunity for parents to distance themselves from conflict-laden homework sessions. Since the market for smartphone apps in the health care and well-being sector is primarily industry driven, it is crucial to have an academic conception and evaluation of such digital tools.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04857788; https://clinicaltrials.gov/ct2/show/NCT04857788.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44553.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/836a/11621713/858f143702eb/resprot_v13i1e44553_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/836a/11621713/668b9b4e587e/resprot_v13i1e44553_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/836a/11621713/858f143702eb/resprot_v13i1e44553_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/836a/11621713/668b9b4e587e/resprot_v13i1e44553_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/836a/11621713/858f143702eb/resprot_v13i1e44553_fig2.jpg
摘要

背景

注意力缺陷/多动障碍(ADHD)影响着 4%至 5%的普通人群。家庭作业时间是经常发生冲突的时刻,孩子们会感到焦虑,而父母则感到压力,这导致家庭生活质量下降。与普通发展同龄人相比,ADHD 儿童经历更严重的家庭作业问题。ADHD 个体学业成绩不佳部分归因于具有挑战性的家庭作业。心理教育和基于学校的方法既费时又不能完全为专业人员所接受。智能手机和平板电脑等数字工具可能是一种有趣的替代方法。我们介绍了我们的儿童和青少年数字家庭作业支持计划,称为“Programme d'Aide Numérique aux Devoirs pour Enfant avec TDA-H”(PANDAH),以及我们正在进行的随机对照试验的研究方案。

目的

本研究旨在测试 PANDAH 提高家庭作业表现和家庭生活质量的效果。

方法

纳入年龄在 9 至 16 岁之间、有 ADHD 诊断且无共患精神障碍的个体。这是一项涉及法国 9 个 ADHD 参考中心的多中心研究。该研究包括(1)为期 3 个月的随机对照试验设计,参与者分为 2 个平行组(组 1:常规护理或候补名单;组 2:PANDAH 应用程序),随后(2)扩展期 3 个月(第 3 至 6 个月),在此期间所有参与者都可以使用该应用程序。这第二个阶段是对最初随机分配到组 1 的患者的重要激励。由经过培训的心理学家在基线、第 3 个月和第 6 个月对每位患者进行评估。主要终点是全球家庭作业表现问卷(HPQ)的父母版本在第 6 个月的评分。主要分析将遵循“意向治疗原则”(根据随机分组确定所有患者的数据)。我们预计(1)与未使用该应用程序的患者相比,使用该应用程序的患者在头 3 个月期间的 HPQ 评分有所提高;(2)与仅使用该应用程序 3 个月的患者相比,使用该应用程序 6 个月的患者的 HPQ 评分有更大的提高;以及(3)通过应用内指标衡量对 PANDAH 计划的依从性。

结果

研究于 2024 年 1 月开始招募,目前正在进行中。

结论

这项研究为医疗保健的数字化转型做出了贡献。智能手机应用程序在自我保健和自我管理中的使用是一种社会现象,在精神病学领域的实施具有特别的意义。该应用程序既可以为患者提供有价值的支持,也可以为父母提供一个远离充满冲突的家庭作业时间的机会。由于智能手机应用程序在医疗保健和健康领域的市场主要由行业驱动,因此对这类数字工具进行学术概念和评估至关重要。

临床试验注册

ClinicalTrials.gov NCT04857788;https://clinicaltrials.gov/ct2/show/NCT04857788。

国际注册报告标识符(IRRID):PRR1-10.2196/44553。

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