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NCT Number: NCT07704619

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MaKey MaKey and Scratch Co-Creation Workshop Program

Behavioral

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.

Primary outcomes

  1. Change in social participation from baseline to post-intervention

    Time frame: 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.

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

    Time frame: 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.

  3. Change in perceived empowerment from baseline to post-intervention

    Time frame: 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.

Secondary outcomes

  1. Change in occupational balance from baseline to post-intervention

    Time frame: 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.

  2. Perceived usability of MaKey MaKey and Scratch after the intervention

    Time frame: 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.

  3. Percentage of scheduled workshop sessions attended by each participant

    Time frame: 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.

  4. Percentage of participants who discontinue the workshop program

    Time frame: 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.

  5. Frequency of observed participation indicators during the workshop sessions

    Time frame: 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.

  6. Number and type of workshop-related incidents during the intervention

    Time frame: 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.

  7. Number and type of adaptations implemented during the workshop sessions

    Time frame: 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.

  8. Participants' experience of the co-creation workshop program

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nuria García-Gonzalo, Occupational Therapist

CONTACT

[email protected]

Patricia Concheiro-Moscoso, PhD

CONTACT

[email protected]

0034981167000 ext. 5870

Sponsors and collaborators

Lead sponsor

Universidade da Coruña

Other

Collaborators

  • Center on Information and Communication Technologies
  • Day Hospital at Ferrol Naval Hospital
  • TALIONIS research group

Registry information

Official study title

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

Acronym: MaKey4All

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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