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Mental DisordersMaKey4AllNCT07704619

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

A study testing MaKey MaKey and Scratch Co-Creation Workshop Program in people with Mental Disorders and Social Participation, run by Universidade da Coruña.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MaKey MaKey and Scratch Co-Creation Workshop Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
2 Sep 2026to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Patricia Concheiro-Moscoso, PhD contact

0034981167000 ext. 5870

patricia.concheiro@udc.es

Nuria García-Gonzalo, Occupational Therapist contact

nuria.garcia.gonzalo@udc.es

About this study

Official 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

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.

Read the detailed description

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.

Being tested
MaKey MaKey and Scratch Co-Creation Workshop Program
Keywords
Occupational Balance, Occupational Therapy, Makey Makey, Co-Creation, Feasibility, Creative Technologies, Scratch, Usability
Medical subject headings
Mental Disorders, Empowerment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaKey MaKey and Scratch Co-Creation Workshop ProgramBehavioural

    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.

Study groups in NCT07704619
Study groupRoleWhat they receive
MaKey MaKey and Scratch Co-Creation Workshop ProgramExperimentalParticipants 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.
Receives: Behavioral: MaKey MaKey and Scratch Co-Creation Workshop Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

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

    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.

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

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

    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.

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

Secondary outcomes (8)

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

    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.

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

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

    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.

    Measured: Post-intervention: immediately after completion of the participant's final workshop session, following 6 to 8 sessions.

  3. Percentage of scheduled workshop sessions attended by each participant

    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.

    Measured: At each workshop session, up to 8 weeks.

  4. Percentage of participants who discontinue the workshop program

    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.

    Measured: At the end of the intervention period, up to 8 weeks.

  5. Frequency of observed participation indicators during the workshop sessions

    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.

    Measured: At each workshop session, up to 8 weeks.

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

    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.

    Measured: At each workshop session, up to 8 weeks.

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

    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.

    Measured: At each workshop session, up to 8 weeks.

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

    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.

    Measured: Immediately post-intervention, up to 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start2 Sep 2026 (estimated)
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07704619
Sponsor's protocol ID
2026/270
Acronym
MaKey4All
Status last verified
Jul 2026
First submitted
2 Jul 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guarda GF, Fausto IRS, García-García JA, Braz RMM, Leta FR, Pinto SCCS. The Makey Makey inclusive tangible interface and its educational perspectives. In: Anais do XXXIII Simpósio Brasileiro de Informática na Educação. Porto Alegre: Sociedade Brasileira de Computação; 2022. p. 741-751. doi:10.5753/sbie.2022.225641.

  • World Health Organization. World mental health report: transforming mental health for all. Geneva: World Health Organization; 2022.

  • Brooke J. SUS: a quick and dirty usability scale. In: Jordan PW, Thomas B, McClelland IL, Weerdmeester B, editors. Usability evaluation in industry. London: Taylor & Francis; 1996. p. 189-194.

  • Beginner's Mind Collective, Shaw D. Makey Makey: improvising tangible and nature-based user interfaces. In: Proceedings of the Sixth International Conference on Tangible, Embedded and Embodied Interaction; 2012 Feb 19-22; Kingston, Ontario, Canada. New York: Association for Computing Machinery; 2012. p. 367-370. doi:10.1145/2148131.2148219.

  • Resnick M, Maloney J, Monroy-Hernández A, Rusk N, Eastmond E, Brennan K, et al. Scratch: programming for all. Commun ACM. 2009 Nov;52(11):60-67. doi:10.1145/1592761.1592779.

  • Hawke LD, Sheikhan NY, Bastidas-Bilbao H, Rodak T. Experience-based co-design of mental health services and interventions: a scoping review. SSM Ment Health. 2024 Jun;5:100309. doi:10.1016/j.ssmmh.2024.100309.

  • McAuley E, Duncan T, Tammen VV. Psychometric properties of the Intrinsic Motivation Inventory in a competitive sport setting: a confirmatory factor analysis. Res Q Exerc Sport. 1989 Mar;60(1):48-58. doi: 10.1080/02701367.1989.10607413.

    PubMed 2489825

  • Alonso J, Olivares J, Ciudad A, Manresa J, Casado A, Gilaberte I. [Development and validation of the Social Functioning Scale, short version, in schizophrenia for its use in the clinical practice]. Actas Esp Psiquiatr. 2008 Mar-Apr;36(2):102-10. Spanish.

    PubMed 18365790

  • Sampietro HM, Guilera G, Berrio AI, Barrios M, Rojo JE, Gomez-Benito J. A short form of the Spanish version of the Netherlands empowerment list: development and validation. Soc Psychiatry Psychiatr Epidemiol. 2026 Mar;61(3):575-585. doi: 10.1007/s00127-025-02970-9. Epub 2025 Jul 30.

    PubMed 40739456

  • Peral-Gomez P, Lopez-Roig S, Pastor-Mira MA, Abad-Navarro E, Valera-Gran D, Hakansson C, Wagman P. Cultural Adaptation and Psychometric Properties of the Spanish Version of the Occupational Balance Questionnaire: An Instrument for Occupation-Based Research. Int J Environ Res Public Health. 2021 Jul 14;18(14):7506. doi: 10.3390/ijerph18147506.

    PubMed 34299957

Questions about this trial

What is this clinical trial studying?

A study testing MaKey MaKey and Scratch Co-Creation Workshop Program in people with Mental Disorders and Social Participation, run by Universidade da Coruña.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patricia Concheiro-Moscoso, PhD (0034981167000 ext. 5870, patricia.concheiro@udc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07704619, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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