Clinical trial NCT04548115: ARTISAN 2.0: Deconstructing the Integrative Efficacy of a Multimodal Art-based Intervention
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intergenerational Relations
Loneliness
Well Aging
Keywords: Arts-based Intervention, Cultural Heritage
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
Collaborators: name: National Museum of Singapore
First posted: 2020-09-14
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using site randomization, each higher education institution will be randomized into one of the five RCT conditions (i.e. full ARTISAN, participatory arts, art space, storytelling and control), and each elderly care agency will be randomized into one of the same five conditions. Based on randomization outcome, one higher education institution will be paired with one elderly care agency, the paired collaborating sites will be allocated to the same RCT condition. Participant recruitment will be simultaneously conducted at each paired sites through 5 sequential rounds, and each round will recruit 2 groups, totalling 10 groups for the entire study. Each group will comprise 14 participants with youths and senior to be randomized paired as dyads, who will undergo a 5-week RCT condition with a follow-up assessment at 10-weeks. At any given time during the study, 2 groups will be run concurrently until all 10 groups complete the RCT.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Loneliness (ULS-8) scores from baseline
timeFrame: 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).
measure: Changes in Resilience (ER-11) scores from baseline
timeFrame: 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).
measure: Changes in Social Connectedness (MOS-SS) scores from baseline
timeFrame: 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).
measure: Changes in National and Cultural Identity (NATID) scores from baseline
timeFrame: 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 outcomes:
measure: Changes in Psychological wellbeing (PWB) scores from baseline
timeFrame: 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).
measure: Changes in Depressive symptoms (PHQ-4) scores from baseline
timeFrame: 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).
measure: Changes in Self-esteem (RSES-4) scores from baseline
timeFrame: 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).
measure: Changes in Life satisfaction (SWLS) scores from baseline
timeFrame: 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).
measure: Changes in Quality of life (WHOQoL-8) scores from baseline
timeFrame: 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).
measure: Changes in Spiritual wellbeing (FACIT-Sp) scores from baseline
timeFrame: 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).
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Nanyang Technological University
Study officials:
affiliation: Nanyang Technological University
name: Andy HY Ho, PhD, EdD
role: PRINCIPAL_INVESTIGATOR
References: