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临床试验/NCT06732297
NCT06732297招募中不适用

Stronger Families Through Art Therapy: A Mixed Methods Programme Evaluation Study

Nanyang Technological University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
96
试验地点
1
主要终点
Self-rated quality of life for caregiver participants

研究概览

简要总结

The current research aims to evaluate the effectiveness and feasibility of the Strong Families Through Art Therapy (SFAT) programme, which was developed to improve the parent-child relationship in vulnerable families. The main questions it aims to answer are:

  1. Is the programme effective in enhancing quality of life and family resilience among parents?
  2. Is the programme effective in enhancing quality of life among children?
  3. Is the programme feasible and acceptable for large scale implementation in Singapore?

Researchers will compare the status of family participants (caregivers and children) before and after they take the programme and compare family participants who take the programme with family participants who have not yet taken the programme to see if the programme is effective in benefiting the participants. Researchers will also invite family participants to discuss about the programme.

Family participants will

  1. Take the 10-week SFAT programme
  2. Complete assessment survey for 3 times
  3. Attend a focus group discussion (optional)

To assess the programme feasibility, researchers will additional invite art therapist participants to evaluate the programme and invite community staff participants to discuss about the programme implementation.

Art therapist participants will complete programme and session evaluation reports.

Community staff participants will attend a focus group discussion.

详细描述

The current research aims to evaluate the effectiveness and feasibility of the Strong Families Through Art Therapy (SFAT) programme, which was developed to improve the parent-child relationship in vulnerable families. Service users of the SFAT programme will receive a progressive support from workshops, dyad art therapy, and an innovative art-based self-care tool developed with a multidisciplinary team to meet the needs of enhancing family communication and strengthening emotional bonding. The current research utilizes a pragmatic mixed method research paradigm to evaluate the programme. For the quantitative component, a single-site, open label, Waitlist Randomized Control Trial (RCT) design, comprising two arms: (i) treatment group and (ii) waitlist control group, will be adopted to evaluate the efficacy of the Strong Families Through Art Therapy (SFAT) for improving quality of life and family resilience among parents and children. For the qualitative component, an embedded qualitative focus group evaluation study with participants who complete the SFAT programme, together with analysis of intervention session evaluation forms completed by art therapists who conduct the SFAT programme and focus group discussion completed by community staff who support to implement the programme, will be conducted to evaluate programme acceptability and feasibility. After signing the informed consent form, the recruited family (consisting of one parent and one to three children dyads) will be asked to complete a baseline assessment before randomization and the start of the SFAT programme [T1]. Family participants in the treatment group will then undergo an 10-week SFAT programme conducted by the Red Pencil (Singapore) team, complete an immediate post-intervention assessment [T2], with a final follow-up assessment at 20-weeks [T3]. Family participants in the waitlist control group will complete a pre-intervention assessment before start of the SFAT programme at 10-weeks [T2], then undergo the same 10-week SFAT programme conducted by the Red Pencil (Singapore) team and complete an immediate post-intervention assessment at 20-weeks [T3]. Moreover, selected family participants will be invited to take part in an acceptability focus group study after T3 assessments. Post-session evaluation forms will also be completed by art therapist participants after session completion and focus group discussion will be held for community staff participants to discuss on the programme implementation. Figure 1 details the study procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (family participant):
  • the caregiver (including parents, grandparents, family members or foster parents who perform the main caretaking responsibilities of the children taking part in SFAT) of a young child who can communicate in English and provide informed consent
  • the child is aged 7-14 years and can communicate in English
  • the family have one or more of the following identified challenges: (1) caregiver stress such as finances, household management, work and childcare arrangements, (2) caregiver struggles to find time for self-care and quality time with children, (3) caregiver has minimal understanding of the psychological and emotional needs of their children, (4) children face difficulties with emotional regulation and anger management
  • caregivers and children are from low-income families who receive financial assistance under the CHAS Blue card, ComCare financial assistance, and/or the MOE Financial Assistance Scheme
  • Inclusion criteria (art therapist participant) registered art therapist based in the Red Pencil (Singapore) who are in charge of delivering the SFAT programme
  • Inclusion criteria (community staff participant)
  • - community staff who provides assistance to the implementation of the SFAT programme

排除标准

  • individuals who are suffering from depression or other major mental health conditions that would render their participation highly disruptive to others in a group setting, and/or cannot provide informed consent. Families will also be excluded if they are currently unstable (i.e. circumstances related to abuse/neglect), and/or have high risk of suicidal and self-harm behaviours. In the cases that individuals referred to the programme are not eligible, the partner organisations will assess their needs and refer them to programmes based on these needs.
  • participant is unable to provide informed consent

研究组 & 干预措施

Immediate Treatment Group

Experimental

Family participants in the immediate treatment group will undergo the intervention after baseline assessment and randomization. The intervention consists of 1.5-hour art-therapy sessions which happen every week for 10 weeks. The topics of intervention sessions include building rapport, emotional expression & regulation, self-care, communication & collaboration, and reflection & community.

干预措施: dyadic art therapy intervention for parent-child relationship in vulnerable families (Behavioral)

Waitlist Control Group

Other

Family participants in the waitlist control group will undergo the intervention after participants in the immediate treatment group complete the intervention. Participants in the two group undergo the same intervention.

干预措施: dyadic art therapy intervention for parent-child relationship in vulnerable families (Behavioral)

结局指标

主要结局

Self-rated quality of life for caregiver participants

时间窗: From enrollment to the end of assessment at 20 weeks

The primary outcome will be assessed by the World Health Organization Quality of life Brief Scale (WHOQOL-BREF) \[WHO, 1997\]. The WHOQOL-BREF comprises 26-items rated on a 5-point Likert scale and clustered into the four subscales of physical health, psychological health, social relationships, and environmental health. The WHOQOL-BREF possesses strong internal validity, reliability, and cross-cultural applicability.

Self-rated quality of life for child participants

时间窗: From enrollment to the end of assessment at 20 weeks

The primary outcome will be assessed by the KIDSCREEN-30 tool \[Ravens-Sieberer, U., et al., 2013\]. The KIDSCREEN-30 comprises of 30 items rated on a 4-point visual Likert scale and clustered into the 8 domains of physical wellbeing, psychological wellbeing, moods and emotions, autonomy and parent relation, financial resources, social support and peers, school environment and social acceptance. KIDSCREEN30 possesses strong internal validity, reliability, and cross-cultural applicability.

次要结局

  • Self-rated family resilience for caregiver participants(From enrollment to the end of assessment at 20 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andy Hau Yan Ho, PhD, EdD

Professor

Nanyang Technological University

研究点 (1)

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