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Co-Creation Workshops With MaKey MaKey to Promote Participation Among People With Mental Health Conditions (MaKey4All)

9 de julho de 2026 atualizado por: Patricia Concheiro Moscoso, Universidade da Coruña

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

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: MaKey MaKey and Scratch Co-Creation Workshop Program
Participants in this single arm will take part in a group-based co-creation workshop program using MaKey MaKey and Scratch. The program will consist of six weekly sessions lasting approximately 90 minutes each, with the possibility of two additional optional sessions to complete, refine, and present the projects developed. Participants will collaboratively design musical activities, cooperative games, interactive narratives, or other creative projects adapted to their interests, abilities, and support needs.

The intervention is a group-based co-creation program delivered in a mental health day hospital. It will comprise six weekly sessions of approximately 90 minutes each, with up to two optional additional sessions.

During the program, participants will become familiar with MaKey MaKey and Scratch, identify individual and shared interests, propose ideas, design tangible interfaces, perform basic block-based programming, test the projects, solve problems, and progressively refine the activities created. Projects may include musical activities, cooperative games, interactive narratives, visual experiences, or other creative proposals selected by the group.

The workshops will use a participatory and cooperative approach. Support and adaptations may include brief and sequenced instructions, flexible allocation of roles, individual assistance, pauses, adjustment of task difficulty, and reduction of environmental stimuli when necessary.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in social participation from baseline to post-intervention
Prazo: 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.
Pre-Post: baseline, before the first workshop session, and immediately after the participant's final workshop session, following 6 to 8 sessions.
Change in motivation toward participation in the workshops from baseline to post-intervention
Prazo: 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.

Pre-Post: baseline, before the first workshop session, and immediately after the participant's final workshop session, following 6 to 8 sessions.
Change in perceived empowerment from baseline to post-intervention
Prazo: 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.

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in occupational balance from baseline to post-intervention
Prazo: Pre-Post: baseline, before the first workshop session, and immediately after the participant's final workshop session, following 6 to 8 sessions.
Occupational balance will be measured through the self-administered Spanish version of the Occupational Balance Questionnaire (OBQ). The OBQ consists of 13 items assessing the person's perceived satisfaction with the amount and variety of occupations in daily life, as well as the balance between activities, rest, and participation. Each item is scored on a 6-point ordinal scale ranging from 0 (completely disagree) to 5 (completely agree). Score range: 0 to 65. Score interpretation: Higher scores indicate greater perceived occupational balance.
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
Prazo: Post-intervention: immediately after completion of the participant's final workshop session, following 6 to 8 sessions.

Perceived usability of MaKey MaKey and Scratch will be measured through the self-administered System Usability Scale (SUS).

The SUS consists of 10 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Item scores are converted according to the standard scoring procedure to obtain a total score ranging from 0 to 100. Score interpretation: Higher scores indicate greater perceived usability of MaKey MaKey and Scratch.

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
Prazo: At each workshop session, up to 8 weeks.
Attendance will be recorded by the research team at each workshop session. For each participant, the attendance rate will be calculated as the number of workshop sessions attended divided by the total number of workshop sessions offered to that participant, multiplied by 100. Percentage range: 0% to 100%. Higher percentages indicate greater attendance.
At each workshop session, up to 8 weeks.
Percentage of participants who discontinue the workshop program
Prazo: At the end of the intervention period, up to 8 weeks.
Discontinuation will be assessed using the attendance and continuity record completed by the research team. The discontinuation rate will be calculated as the number of enrolled participants who withdraw from the program before the final workshop session offered to them, divided by the total number of enrolled participants, multiplied by 100. The reason for discontinuation will also be recorded when known. Percentage range: 0% to 100%. Higher percentages indicate greater discontinuation from the workshop program.
At the end of the intervention period, up to 8 weeks.
Frequency of observed participation indicators during the workshop sessions
Prazo: At each workshop session, up to 8 weeks.
Observed participation will be assessed using a structured session observation record completed by the research team. At each workshop session, the record will document active participation, interaction with other participants, cooperation, initiative, decision-making, maintenance of a role within the group, understanding of instructions, need for support, and task completion. The frequency of each indicator across the workshop sessions will be summarized descriptively. No overall score will be calculated.
At each workshop session, up to 8 weeks.
Number and type of workshop-related incidents during the intervention
Prazo: At each workshop session, up to 8 weeks.
Workshop-related incidents will be recorded by the research team at each workshop session. Incidents may include technical difficulties, difficulties understanding instructions, fatigue, frustration, overload, conflicts, need for additional breaks, or any other situation affecting participation or the development of the session. The total number of incidents and their frequency by category will be summarized descriptively.
At each workshop session, up to 8 weeks.
Number and type of adaptations implemented during the workshop sessions
Prazo: At each workshop session, up to 8 weeks.
Adaptations implemented to facilitate participation will be recorded by the research team at each workshop session. These may include adjustments to materials, session duration, instructions, level of difficulty, allocation of roles, individual support, breaks, or environmental stimuli. The total number of adaptations and their frequency by category will be summarized descriptively.
At each workshop session, up to 8 weeks.
Participants' experience of the co-creation workshop program
Prazo: Immediately post-intervention, up to 8 weeks.
Participants' experience of the co-creation workshop program will be explored through a face-to-face focus group conducted by one of the principal investigators using a semi-structured guide. The discussion will address participants' perceptions of the sessions, positive aspects, difficulties encountered, facilitating factors, relationships within the group, perceived participation, motivation, empowerment, sense of achievement, and suggestions for improvement. The information collected will be coded and analyzed using thematic content analysis to identify the main themes. No overall numerical score will be calculated.
Immediately post-intervention, up to 8 weeks.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Patricia Concheiro-Moscoso, PhD, CITIC-TALIONIS research group, Faculty of Health Sciences, Universidade da Coruña.
  • Investigador principal: Nuria García Gonzalo, Occupational Therapist, Day Hospital at the Ferrol Naval Hospital. TALIONIS research group, Faculty of Health Sciences, Universidade da Coruña
  • Cadeira de estudo: Javier Pereira, PhD, CITIC-TALIONIS research group, Faculty of Health Sciences, Universidade da Coruña.
  • Cadeira de estudo: Betania Groba, PhD, CITIC-TALIONIS research group, Faculty of Health Sciences, Universidade da Coruña.

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

2 de setembro de 2026

Conclusão Primária (Estimado)

30 de outubro de 2026

Conclusão do estudo (Estimado)

30 de outubro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

2 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de julho de 2026

Primeira postagem (Real)

15 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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