- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07704619
Co-Creation Workshops With MaKey MaKey to Promote Participation Among People With Mental Health Conditions (MaKey4All)
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patricia Concheiro-Moscoso, PhD
- Phone Number: 5870 0034981167000
- Email: patricia.concheiro@udc.es
Study Contact Backup
- Name: Nuria García-Gonzalo, Occupational Therapist
- Email: nuria.garcia.gonzalo@udc.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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. |
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
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. |
Pre-Post: baseline, before the first workshop session, and immediately after the participant's final workshop session, following 6 to 8 sessions.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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. |
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
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.
|
At each workshop session, up to 8 weeks.
|
|
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.
|
At the end of the intervention period, up to 8 weeks.
|
|
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.
|
At each workshop session, up to 8 weeks.
|
|
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.
|
At each workshop session, up to 8 weeks.
|
|
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.
|
At each workshop session, up to 8 weeks.
|
|
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.
|
Immediately post-intervention, up to 8 weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia Concheiro-Moscoso, PhD, CITIC-TALIONIS research group, Faculty of Health Sciences, Universidade da Coruña.
- Principal Investigator: Nuria García Gonzalo, Occupational Therapist, Day Hospital at the Ferrol Naval Hospital. TALIONIS research group, Faculty of Health Sciences, Universidade da Coruña
- Study Chair: Javier Pereira, PhD, CITIC-TALIONIS research group, Faculty of Health Sciences, Universidade da Coruña.
- Study Chair: Betania Groba, PhD, CITIC-TALIONIS research group, Faculty of Health Sciences, Universidade da Coruña.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Disorders
-
Kansas State UniversityAugusta University; Dartmouth College; University of CincinnatiEnrolling by invitationMental Disorders, Severe | Mental Illness PersistentUnited States
-
Rutgers, The State University of New JerseyRecruiting
-
Virginia Commonwealth UniversityCompletedMental Health DisordersUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMental Health DisordersCongo
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedMental Health DisordersNorway
-
York UniversityCanadian Institutes of Health Research (CIHR); North York General HospitalCompletedMental Health DisordersCanada
-
Mindstate Design LabsCompleted
-
University of HaifaCompletedMental Health DisordersIsrael
-
VA Boston Healthcare SystemUS Department of Veterans AffairsCompletedMental Health DisordersUnited States
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Onze...RecruitingMental Disorders, SevereNetherlands