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临床试验/NCT07704619
NCT07704619尚未招募不适用

Design, Implementation, and Evaluation of a Pilot Program of Co-Creation Workshops With MaKey MaKey to Promote Participation Among People With Mental Health Conditions

Universidade da Coruña0 个研究点目标入组 20 人开始时间: 2026年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Change in social participation from baseline to post-intervention

研究概览

简要总结

This pilot study aims to design, implement, and conduct an initial evaluation of a group-based co-creation workshop program using MaKey MaKey and Scratch for adults attending a mental health day hospital. The program will use low-cost creative technologies as tools to promote social participation, motivation, and empowerment through cooperative experiences adapted to participants' interests, abilities, and needs.

The intervention will consist of six weekly sessions lasting approximately 90 minutes each, with the possibility of two additional sessions to complete and present the projects developed. Participants will collaborate in the design of musical activities, cooperative games, interactive narratives, or other creative projects.

Assessments will be conducted before and after the intervention, and information will be collected on attendance, participation, usability, incidents, support needs, and adaptations. The feasibility and acceptability of the program, as well as participants' experiences, will also be explored to inform its improvement and potential future implementation in other mental health services.

详细描述

People with mental health conditions may experience difficulties that extend beyond clinical symptoms and affect daily functioning, the organization of routines, the performance of meaningful roles, and participation in social and community activities. From a recovery-oriented perspective, mental health care is not limited to symptom reduction but seeks to support people in building meaningful lives by promoting autonomy, participation, and decision-making capacity.

Mental health day hospitals provide a structured therapeutic setting situated between inpatient hospitalization and outpatient care. These services deliver individual and group interventions aimed at supporting the acquisition and maintenance of skills, the reorganization of routines, social interaction, and the gradual recovery of personal and community roles. However, one of the main challenges faced by psychosocial rehabilitation programs is providing activities that are meaningful, motivating, flexible, and sufficiently adaptable to service users' interests, abilities, and needs.

Co-creation approaches may help address this challenge by placing participants in an active role throughout the design, development, and adaptation of activities. Rather than acting solely as recipients of a predefined intervention, participants can propose ideas, make decisions, create, experiment, solve problems, and contribute to the group's work. This approach may promote motivation, cooperation, shared decision-making, a sense of belonging, and recognition of one's own abilities.

In this context, low-cost creative technologies can be used as tools to facilitate participation. Scratch is a block-based visual programming environment that enables users to create interactive digital projects without requiring advanced programming skills. MaKey MaKey is an interactive circuit board that transforms everyday objects and conductive materials into tangible interfaces connected to a computer. Combining both tools enables the development of experiences that integrate digital creation with object manipulation, bodily interaction, and cooperative work.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receive care at the Mental Health Day Hospital at Ferrol Naval Hospital.
  • Be at least 18 years of age or older.
  • Attend the Mental Health Day Hospital and participate in its activities.

排除标准

  • Have significant health complications that interfere with active participation in the study.
  • Have substantial comprehension or communication difficulties that prevent participation in the workshops or understanding of the study information.

结局指标

主要结局

Change in social participation from baseline to post-intervention

时间窗: Pre-Post: baseline, before the first workshop session, and immediately after the participant's final workshop session, following 6 to 8 sessions.

Social participation will be measured through the self-administered Spanish short version of the Social Functioning Scale (SFS). The short version of the SFS consists of 15 items assessing social isolation and activities, interpersonal communication, independence in daily functioning, leisure activities, prosocial behavior, and employment or occupation. The instrument provides a single overall score. Score range: 0 to 45. Score interpretation: Higher scores indicate better social functioning and participation.

Change in motivation toward participation in the workshops from baseline to post-intervention

时间窗: Pre-Post: baseline, before the first workshop session, and immediately after the participant's final workshop session, following 6 to 8 sessions.

Motivation toward participation in the workshops will be measured through a self-administered, study-specific brief motivation questionnaire. The questionnaire consists of 5 items assessing interest in participating, enjoyment of the activities, perceived involvement, perceived usefulness, and willingness to participate in similar activities in the future. Each item is scored on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Score range: 0 to 25. Score interpretation: Higher scores indicate greater motivation toward participation in the workshops.

Change in perceived empowerment from baseline to post-intervention

时间窗: Pre-Post: baseline, before the first workshop session, and immediately after the participant's final workshop session, following 6 to 8 sessions.

Perceived empowerment will be measured through the self-administered Spanish 12-item short version of the Netherlands Empowerment List (NEL-12). The NEL-12 consists of 12 items assessing different aspects of empowerment, including confidence and purpose, social support, self-management, connectedness, and caring community. Each item is scored on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Score range: 12 to 60. Score interpretation: Higher scores indicate a higher level of perceived empowerment.

次要结局

  • Change in occupational balance from baseline to post-intervention(Pre-Post: baseline, before the first workshop session, and immediately after the participant's final workshop session, following 6 to 8 sessions.)
  • Perceived usability of MaKey MaKey and Scratch after the intervention(Post-intervention: immediately after completion of the participant's final workshop session, following 6 to 8 sessions.)
  • Percentage of scheduled workshop sessions attended by each participant(At each workshop session, up to 8 weeks.)
  • Percentage of participants who discontinue the workshop program(At the end of the intervention period, up to 8 weeks.)
  • Frequency of observed participation indicators during the workshop sessions(At each workshop session, up to 8 weeks.)
  • Number and type of workshop-related incidents during the intervention(At each workshop session, up to 8 weeks.)
  • Number and type of adaptations implemented during the workshop sessions(At each workshop session, up to 8 weeks.)
  • Participants' experience of the co-creation workshop program(Immediately post-intervention, up to 8 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Concheiro Moscoso

Assistant Professor in Occupational Therapy, PhD in Health Sciences

Universidade da Coruña

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