NCT07704619

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 2, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 2, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

Occupational BalanceOccupational TherapyMakey MakeyCo-CreationFeasibilityCreative TechnologiesScratchUsability

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

    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 Outcomes (8)

  • 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.

  • +3 more secondary outcomes

Study Arms (1)

MaKey MaKey and Scratch Co-Creation Workshop Program

EXPERIMENTAL

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.

Behavioral: MaKey MaKey and Scratch Co-Creation Workshop Program

Interventions

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.

MaKey MaKey and Scratch Co-Creation Workshop Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 2489825BACKGROUND
  • 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.

    PMID: 18365790BACKGROUND
  • 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.

    PMID: 40739456BACKGROUND
  • 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.

    PMID: 34299957BACKGROUND

MeSH Terms

Conditions

Mental DisordersEmpowerment

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • 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.

    STUDY CHAIR

Central Study Contacts

Patricia Concheiro-Moscoso, PhD

CONTACT

Nuria García-Gonzalo, Occupational Therapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Occupational Therapy, PhD in Health Sciences

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 15, 2026

Study Start (Estimated)

September 2, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share