- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04548115
ARTISAN 2.0: Deconstructing the Integrative Efficacy of a Multimodal Art-based Intervention
ARTISAN 2.0: Deconstructing the Integrative Efficacy of a Multimodal Art-based Intervention to Strengthen Understanding and Demystify Misconceptions on Arts, Heritage, and Health
Study Overview
Status
Conditions
Detailed Description
Objective: The core objective is to critically investigate and assess the independent and combined efficacy of each key intervention components of ARTISAN's multimodal framework, which consist of: 1) full ARTISAN condition; 2) intergenerational participatory arts condition; 3) intergenerational art space condition; 4) intergenerational storytelling condition; and 5) control condition of physical activity.
Methods: Utilizing a five-arm, multicentre randomized controlled trial (RCT) design, 70 youths and 70 seniors (N=140) from 10 collaborating sites will be invited to participate in a 5-weeks intervention programme under one of five conditions (ARTISAN condition, Participatory Arts condition, Art-space condition, Storytelling condition, Control condition). Quantitative measurements will be taken at baseline, immediately after the intervention, and ten week post baseline the interventions.
Significance: The results generated will serve to illuminate the intricate pathways in which arts and heritage can cultivate positive life changes, and address misconceptions and about the pivotal roles that arts and heritage play in health promotion.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 637332
- Nanyang Technological University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Youth between the age of 16 to 35
- Community-dwelling seniors above the age of 60
- Fluent in verbal English or Mandarin
Exclusion Criteria:
- Individuals who are unable to provide informed consent (or parental consent where applicable)
- Individuals diagnosed with major mental illness or cognitive impairment (If deemed appropriate, potential senior participants will be screened by the NTU research team using the Mini-Mental State Examination (MMSE))
- Participants who had engaged in the ARTISAN pilot study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: ARTISAN Condition
Participants assigned to this arm will engage in ARTISAN, a 5-weekly, 15-hour group-based arts and heritage intervention programme with specific intervention components including curated museum tours, facilitated storytelling and professionally-led art-making.
The weekly intervention covers the five ARTISAN themes of national heritage, social bonds, adversity and resilience, dreams and aspiration, and community art exhibition.
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Youth and senior participants will be randomly paired and engage in the 5-weekly, 3-hour ARTISAN intervention as dyads (totaling 15 hours of intervention).
In the first four weeks of the ARTISAN, dyads will engage in themed museum tours facilitated by a docent (45min), guided storytelling (45 min) and professionally-led art-making (45 min).
The remaining time (45 min) is allocated for session breaks, session introduction/closing, and buffer time for movement around the gallery.
The final week involves an exhibition where participants share their artworks with the public and reflect on their experiences and artworks.
The weekly session themes are as follows: Week 1: Discovering our National Heritage (Art medium: Clay); Week 2: Strengthening Social Bonds (Art medium: Acrylic Paints); Week 3: Overcoming Adversities and Resilience (Art medium: Beads); Week 4: Building Dreams and Aspirations (Art medium: Recycled Materials); Week 5: Sharing our Stories and Legacies (Community Showcase)
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EXPERIMENTAL: Intergenerational Participatory Arts Condition
Participants assigned to this arm will engage in the participatory arts-making component of the ARTISAN Intervention framework.
Youths and senior participants in this condition will engage in a 5-weekly, 5-hour, group-based professionally-led art-making that covers the five ARTISAN themes.
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Youths and senior participants in this condition will be randomly paired and engage in a 5-weekly 45-minute group-based art activity conducted in a community space with 15 minutes of preparation/break time (totaling 5 hours of intervention).
A professional artist or art therapist will facilitate art-making sessions with the participants in a community space, utilizing the same mediums that were used in ARTISAN.
The weekly session themes are as follows: Week 1: Discovering our National Heritage (Art medium: Clay); Week 2: Strengthening Social Bonds (Art medium: Acrylic Paints); Week 3: Overcoming Adversities and Resilience (Art medium: Beads); Week 4: Building Dreams and Aspirations (Art medium: Recycled Materials); Week 5: Sharing our Stories and Legacies (Community Showcase)
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EXPERIMENTAL: Intergenerational Art-space Condition
Participants assigned to this arm will engage in the cultural space component of the ARTISAN Intervention framework.
Youths and senior participants in this condition will engage in a 5-weekly, 5-hour, group-based a group-based curated museum tour that covers the five ARTISAN themes.
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Youths and senior participants in this condition will engage in a 5-weekly 45-minute group-based curated museum tour that follow the ARTISAN themes with 15 minutes of preparation/break time, and conducted by a trained docent at the National Museum Singapore (totaling 5 hours of intervention).The weekly session themes are as follows: Week 1: Discovering our National Heritage; Week 2: Strengthening Social Bonds; Week 3: Overcoming Adversities and Resilience; Week 4: Building Dreams and Aspirations; Week 5: Sharing our Stories and Legacies.
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EXPERIMENTAL: Inter-generational Storytelling Condition
Participants assigned to this arm will engage in the storytelling component of the ARTISAN Intervention framework.
Youths and senior participants in this condition will be paired to engage in a 5-weekly, 5-hour, group-based guided storytelling activity that covers the five ARTISAN themes.
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Youths and senior participants in this condition will be paired to engage in a 5-weekly 45 minute group-based storytelling activity conducted in a community space with 15 minutes of preparation/break time (totaling 5 hours of intervention).
Storytelling sessions will be conducted by a trained facilitator, and conversation starters from ARTISAN intervention will be used.
The weekly session themes are as follows: Week 1: Discovering our National Heritage; Week 2: Strengthening Social Bonds; Week 3: Overcoming Adversities and Resilience; Week 4: Building Dreams and Aspirations; Week 5: Sharing our Stories and Legacies.
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EXPERIMENTAL: Control Condition
Participants assigned to this arm will engage in a 5-weekly, 5-hour, group-based physical activity session conducted in the community.
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Participants in this condition will engage in a 5-weekly 45 minute group-based physical activity session conducted in the community with 15 minutes of preparation/break time (totaling 5 hours of intervention).
Physical activity was selected over basic psychosocial care to test the effects of inter-generational contact independent of arts and heritage-based engagements.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Loneliness (ULS-8) scores from baseline
Time Frame: Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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The 8-item UCLA Loneliness Scale (ULS-8) is used to assess Loneliness.
Participants will be asked to indicate their agreement for statements on a 4-point scale.
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Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Changes in Resilience (ER-11) scores from baseline
Time Frame: Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Resilience is assessed by the 11-item refined version of Ego-Resilience Scale (ER-11).
Participants will be asked to indicate their agreement for statements on a 4-point scale.
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Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Changes in Social Connectedness (MOS-SS) scores from baseline
Time Frame: Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Social Connectedness is measured by the Emotional, Affectionate, and Positive Interaction sub-scales of the Medical Outcome Study Social Support Survey (MOS-SS).
Participants will be asked to respond to 14-items on a 5-point likert scale.
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Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Changes in National and Cultural Identity (NATID) scores from baseline
Time Frame: Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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National identity is assessed by a modified version of the National Identity Scale (NATID) which comprises 8-items.
Participants will be asked to rate their agreement on statements regarding national heritage and cultural homogeneity on a 7-point likert scale.
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Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in Psychological wellbeing (PWB) scores from baseline
Time Frame: Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Psychological wellbeing is measured by the Personal Growth and Self-Acceptance sub-scales of the Ryff's Psychological Wellbeing Scale (PWB) which comprises 18 items.
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Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Changes in Depressive symptoms (PHQ-4) scores from baseline
Time Frame: Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Depressive symptoms is assessed by the 4-item brief version of the Patient Health Questionnaire (PHQ-4).
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Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Changes in Self-esteem (RSES-4) scores from baseline
Time Frame: Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Self-esteem is measured by the 4-item shortened-version of the Rosenberg's Self-Esteem Scale (RSES-4).
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Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Changes in Life satisfaction (SWLS) scores from baseline
Time Frame: Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Life satisfaction is assessed by the single-item Satisfaction with Life Scale (SWLS).
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Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Changes in Quality of life (WHOQoL-8) scores from baseline
Time Frame: Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Perceived quality of life is measured by the 8-item WHO Quality of Life Scale-8 (WHOQoL-8/EUROHIS-QOL).
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Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Changes in Spiritual wellbeing (FACIT-Sp) scores from baseline
Time Frame: Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Spiritual wellbeing is measured by the 8-item peace and meaning subscales of the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-Sp).
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Participants will be assessed at three time points: [T1] baseline; [T2] immediately post-intervention/second baseline (5 weeks post T1); and [T3] 5 weeks follow-up/ immediately post-intervention (5 weeks post T2).
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Other Study ID Numbers
- IRB-2020-02-006
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
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