Intergenerational RelationsNCT04548115
ARTISAN 2.0: Deconstructing the Integrative Efficacy of a Multimodal Art-based Intervention
A study testing ARTISAN Condition, Intergenerational Participatory Arts Condition and Intergenerational Art-space Condition in people with Intergenerational Relations and Loneliness, run by Nanyang Technological University at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intergenerational Relations, Loneliness, Well Aging
- What is being tested?
- ARTISAN Condition, Intergenerational Participatory Arts Condition and Intergenerational Art-space Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2020to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Youth between the age of 16 to 35
- Community-dwelling seniors above the age of 60
- Fluent in verbal English or Mandarin
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Stephanie HX Ma, MA contact
Singapore1 site
Nanyang Technological University
Singapore, 637332
Andy HY Ho, PhD, EdD, +65 63168943, andyhyho@ntu.edu.sg
Stephanie HX Ma, MA, step0039@e.ntu.edu.sg
About this study
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
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.
Read the 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.
- Conditions
- Intergenerational Relations, Loneliness, Well Aging
- Being tested
- ARTISAN Condition, Intergenerational Participatory Arts Condition, Intergenerational Art-space Condition, Intergenerational Storytelling Condition, Control Condition
- Keywords
- Arts-based Intervention, Cultural Heritage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTISAN ConditionBehavioural
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 ConditionBehavioural
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 ConditionBehavioural
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 ConditionBehavioural
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 ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ARTISAN Condition | Experimental | 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. Receives: Behavioral: ARTISAN Condition |
| Intergenerational Participatory Arts Condition | Experimental | 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. Receives: Behavioral: Intergenerational Participatory Arts Condition |
| Intergenerational Art-space Condition | Experimental | 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. Receives: Behavioral: Intergenerational Art-space Condition |
| Inter-generational Storytelling Condition | Experimental | 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. Receives: Behavioral: Intergenerational Storytelling Condition |
| Control Condition | Experimental | Participants assigned to this arm will engage in a 5-weekly, 5-hour, group-based physical activity session conducted in the community. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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 (6)
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.
Measured: 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).
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).
Measured: 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).
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).
Measured: 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).
Changes in Life satisfaction (SWLS) scores from baseline
Life satisfaction is assessed by the single-item Satisfaction with Life Scale (SWLS).
Measured: 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).
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).
Measured: 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).
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study startDec 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intergenerational RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- National Museum of Singapore
- Responsible party
- Principal investigator, Andy Hau Yan Ho, PhD, EdD, Nanyang Technological University
- Investigators
- Andy HY Ho, PhD, EdD, Principal investigator, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548115
- Sponsor's protocol ID
- IRB-2020-02-006
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04548115
- Acronym / sponsor ID
- IRB-2020-02-006
- Conditions
- Intergenerational Relations, Loneliness, Well Aging
- Keywords
- Arts-based Intervention, Cultural Heritage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- National Museum of Singapore
- Study start
- Dec 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| ARTISAN Condition | Experimental | Behavioral: ARTISAN ConditionParticipants 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. |
| Intergenerational Participatory Arts Condition | Experimental | Behavioral: Intergenerational Participatory Arts ConditionParticipants 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. |
| Intergenerational Art-space Condition | Experimental | Behavioral: Intergenerational Art-space ConditionParticipants 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. |
| Inter-generational Storytelling Condition | Experimental | Behavioral: Intergenerational Storytelling ConditionParticipants 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. |
| Control Condition | Experimental | Behavioral: Control ConditionParticipants assigned to this arm will engage in a 5-weekly, 5-hour, group-based physical activity session conducted in the community. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Youth between the age of 16 to 35
- Community-dwelling seniors above the age of 60
- Fluent in verbal English or Mandarin
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTISAN ConditionYouth 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) | Behavioural | ARTISAN Condition |
| Intergenerational Participatory Arts ConditionYouths 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) | Behavioural | Intergenerational Participatory Arts Condition |
| Intergenerational Art-space ConditionYouths 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. | Behavioural | Intergenerational Art-space Condition |
| Intergenerational Storytelling ConditionYouths 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. | Behavioural | Inter-generational Storytelling Condition |
| Control ConditionParticipants 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. | Behavioural | Control Condition |
Primary outcome
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).
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.
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).
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.
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).
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.
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).
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.
6 secondary outcomes
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).
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).
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).
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- ARTISAN Pilot Study IntroductionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie HX Ma, MA contact
Andy HY Ho, PhD, EdD principal investigator
Nanyang Technological University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTISAN Condition, Intergenerational Participatory Arts Condition and Intergenerational Art-space Condition in people with Intergenerational Relations and Loneliness, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy HY Ho, PhD, EdD (+65 6316 8943, andyhyho@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.