Smeets Gerianne, Volkers Karin, Scherder Erik, Moonen Xavier
Philadelphia Care Foundation, Amersfoort, Netherlands.
Department of Clinical Neuropsychology, VU University Amsterdam, Amsterdam, Netherlands.
JMIR Res Protoc. 2024 Feb 7;13:e52497. doi: 10.2196/52497.
BACKGROUND: Individuals with intellectual disabilities (ID) are more likely to have problems with executive functioning (EF) and challenging behavior (CB), which are negatively linked to well-being. Among clinical populations, music interventions have been shown to improve various outcome measures, such as CB and EF. Until now, no randomized controlled trials (RCTs) have been conducted to examine the effectiveness of an individual music intervention for adults with ID and CB. OBJECTIVE: The study aims to identify the effect and feasibility of an individual music intervention compared with care-as-usual for people with ID and CB. METHODS: In this study, a 2-group RCT with a pretest, posttest, and follow-up assessment after 8 weeks is presented. Participants of the music intervention condition will receive 16 individual music sessions within 8 to 10 weeks. The music intervention will be guided by a manual for music workers, in which every session will have a different focus (introduction, emotions, different EF, and end performance). Participants receiving care as usual will function as a control group. After the research is finished, they will be offered a budget, which they can spend on musical activities or musical instruments as they wish. Assessments will include caregiver rating scales and self-report questionnaires and tests, which will assess outcome measures of CB, well-being, depression, anxiety, self-esteem, and 4 domains of EF. A process evaluation will be conducted after the completion of the study, which entails the analysis of data on multiple aspects of the intervention and the study overall. RESULTS: Enrollment commenced in July 2021, and data collection ended in May 2023. A total of 97 participants were recruited, with 44 participants allocated to the intervention group and 53 allocated to the control group. Data will be analyzed after this protocol has been accepted for publication. CONCLUSIONS: Because there are currently no published RCTs of an individual music intervention for adults with ID and CB, this study will provide insight into the effectiveness and experiences of an individual music intervention for this target group. TRIAL REGISTRATION: International Clinical Trials Registry Platform NL8482; http://tinyurl.com/4565s5pd. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52497.
背景：智障人士更有可能出现执行功能（EF）问题和挑战行为（CB），这些与幸福感呈负相关。在临床人群中，音乐干预已被证明可以改善各种结果指标，如挑战行为和执行功能。到目前为止，尚未进行随机对照试验（RCT）来检验针对患有智障和挑战行为的成年人的个体音乐干预的有效性。 目的：本研究旨在确定与常规护理相比，个体音乐干预对患有智障和挑战行为的人的效果和可行性。 方法：在本研究中，呈现了一项具有前测、后测以及8周后随访评估的两组随机对照试验。音乐干预组的参与者将在8至10周内接受16次个体音乐课程。音乐干预将由音乐工作者手册指导，其中每次课程都有不同的重点（介绍、情感、不同的执行功能和最终表演）。接受常规护理的参与者将作为对照组。研究结束后，将为他们提供一笔预算，他们可以根据自己的意愿将其用于音乐活动或乐器。评估将包括照顾者评定量表、自我报告问卷和测试，这些将评估挑战行为、幸福感、抑郁、焦虑、自尊和执行功能的4个领域的结果指标。研究完成后将进行过程评估，这需要分析干预和整个研究多个方面的数据。 结果：招募工作于2021年7月开始，数据收集于2023年5月结束。共招募了97名参与者，其中44名参与者被分配到干预组，53名被分配到对照组。在本方案被接受发表后将对数据进行分析。 结论：由于目前尚无针对患有智障和挑战行为的成年人的个体音乐干预的已发表随机对照试验，本研究将深入了解针对该目标群体的个体音乐干预的有效性和体验。 试验注册：国际临床试验注册平台NL8482；http://tinyurl.com/4565s5pd。 国际注册报告识别码（IRRID）：DERR1-10.2196/52497。
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