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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04548115
Other study ID # IRB-2020-02-006
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2020
Est. completion date November 2022

Study information

Verified date September 2020
Source Nanyang Technological University
Contact Andy HY Ho, PhD, EdD
Phone +65 6316 8943
Email andyhyho@ntu.edu.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To address perceived loneliness via citizen empowerment, ARTISAN (Aspiration and Resilience Through Intergenerational Storytelling and Art-based Narratives) was developed by the Principal Investigator in partnership with the National Arts Council and the National Museum of Singapore. A 2018 pilot study was conducted with the aim to establish ARTISAN's intervention framework, as well as to evaluate the effectiveness of the intervention in promoting resilience, social connectedness, wellbeing, personhood and nationhood. The current research builds on the empirical foundation of the pilot study and seeks to deconstruct the ARTISAN intervention for gaining a deeper understanding of its underlying mechanisms for promoting positive life changes among youth and senior participants such as reduced loneliness, enhanced resilience, psychological wellbeing, social connectedness and sense of nationhood.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ARTISAN Condition
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)
Intergenerational Participatory Arts Condition
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)
Intergenerational Art-space Condition
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.
Intergenerational Storytelling Condition
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.
Control Condition
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.

Locations

Country Name City State
Singapore Nanyang Technological University Singapore

Sponsors (2)

Lead Sponsor Collaborator
Nanyang Technological University National Museum of Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Loneliness (ULS-8) scores from baseline 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. 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).
Primary Changes in Resilience (ER-11) scores from baseline 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. 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).
Primary Changes in Social Connectedness (MOS-SS) scores from baseline 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. 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).
Primary Changes in National and Cultural Identity (NATID) scores from baseline 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. 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).
Secondary Changes in Psychological wellbeing (PWB) scores from baseline 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. 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).
Secondary Changes in Depressive symptoms (PHQ-4) scores from baseline Depressive symptoms is assessed by the 4-item brief version of the Patient Health Questionnaire (PHQ-4). 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).
Secondary Changes in Self-esteem (RSES-4) scores from baseline Self-esteem is measured by the 4-item shortened-version of the Rosenberg's Self-Esteem Scale (RSES-4). 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).
Secondary Changes in Life satisfaction (SWLS) scores from baseline Life satisfaction is assessed by the single-item Satisfaction with Life Scale (SWLS). 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).
Secondary Changes in Quality of life (WHOQoL-8) scores from baseline Perceived quality of life is measured by the 8-item WHO Quality of Life Scale-8 (WHOQoL-8/EUROHIS-QOL). 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).
Secondary Changes in Spiritual wellbeing (FACIT-Sp) scores from baseline 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). 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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