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临床试验/NCT05214859
NCT05214859已完成不适用

Enhancing Mother-Child Ties and Psychosocial Wellness Through Arts: A Mixed Methods Study on Dyadic Expressive Arts-based Intervention for Children With Intellectual Disability and Their Mothers

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2022年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
157
试验地点
2
主要终点
Change of Baseline Mothers' Parenting Stress level at 2 months, 5 months, and 8 months

研究概览

简要总结

The caregiving of children with intellectual disability (ID) is intensive and challenging. Caregivers, particularly mothers, are left in a vulnerable and stressful condition. Children with ID may experience difficulties in expressing emotions and may have behavioral or emotional problems. These difficulties impose extra challenges for the parents to understand and interact with their children with ID. Existing intervention programs for families having children with ID primarily focus on problem-and-emotion-focused measures. While strategies focusing on improving parent-child relationships, mother-child communication, and wellness of the dyads are limited.

Expressive arts-based intervention (EXAT) adopts multiple art modalities for achieving therapeutic goals. It can bypass verbal expression and complicated cognitive processing during interactions, and it is also safe, engaging, enjoyable, and empowering. While existing evidence supports the use of arts-based intervention on children and their parents, there is a limited understanding of the application of dyadic EXAT on the mother-child relationship and their wellness.

The main objective of this study is to evaluate the effectiveness of the dyadic Expressive Arts-based Intervention (EXAT) on the psychosocial well-being of mother-child dyads. Primary outcomes include parent-child relationship, parenting stress, and caregiver burnout; secondary outcomes include mother's affect and quality of life; child's mood, emotional expression, behavioral and emotional problems.

This study adopts a mixed-methods design with quantitative, qualitative, and art-based assessment methods. This study is a randomized controlled trial, running for 3 years for evaluating the effectiveness of the dyadic Expressive Arts-based Intervention (EXAT). 154 Chinese mother-child dyads will be randomized into (i) a dyadic EXAT group or (ii) a treatment-as-usual waitlist control group.

Quantitative analysis will be adopted to investigate the effectiveness of the dyadic intervention on the psychosocial outcomes of children with ID and their caregiving mothers. The qualitative component will consist of longitudinal in-depth interviews with mothers to understand the experiences, perceived changes, and factors that facilitate the process. Art-based assessment will also be used to understand the changes in the emotional expression of children with ID. Data collected will be triangulated to provide an integrative evaluation of the effectiveness of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Due to the nature of this trial, neither the staff, participants, nor care provider can be masked to allocation. The data analyst will be blinded during the data analysis process.

入排标准

性别
All
接受健康志愿者

入选标准

  • Eligible participants are mother-child dyads that fulfill the following inclusion criteria.
  • The child is 6-12 years old (primary school student);
  • The child is diagnosed with mild to moderate ID, IQ score ranges from 35 to 69 (based on the assessment conducted by certified clinicians);
  • By the judgement of the health/school professional staff, the child is capable of responding to assessments and participating in group activities;
  • The dyad is willing and able to give consent for participation.

排除标准

  • The dyad is currently participating in any other behavioral or pharmacological trial
  • Either member of the dyad have other contraindications or severe comorbidities that may impair their full participation (e.g., severe physical disabilities)

研究组 & 干预措施

Intervention

Experimental

Participants in the intervention arm will receive Dyadic Expressive Arts Group Therapy as an intervention.

干预措施: The Dyadic Expressive Arts Group Therapy (Behavioral)

The Treatment-as-usual Waitlist Control Group

No Intervention

Participants in the control group will continue their routine healthcare and social services. Upon completion of the 8-month study period, participants will be invited to a similar intervention group program.

结局指标

主要结局

Change of Baseline Mothers' Parenting Stress level at 2 months, 5 months, and 8 months

时间窗: Baseline, Month 2, Month 5, Month 8

The Chinese validated version of the Parenting Stress Index Short-Form will be used to assess the level of parenting stress of the mothers. The index assesses parenting stress in three domains: (i) parental distress, (ii) parent-child dysfunctional interaction, and (iii) difficult child. Higher scores represent higher parenting stress. This index will be filled in by mothers.

Change of Baseline Mothers' Burnout level at 2 months, 5 months, and 8 months

时间窗: Baseline, Month 2, Month 5, Month 8

The Chinese validated version of the client burnout subscale of the Copenhagen Burnout Inventory will be used to assess the level of burnout of the mothers. Higher scores represent higher burnout. This inventory will be filled in by mothers.

Change of Baseline Mothers' perceive Parent-Child Relationship at 2 months, 5 months, and 8 months

时间窗: Baseline, Month 2, Month 5, Month 8

The subscales of parent-child communication and satisfaction with parenting from the Parent-Child Relationship Inventory will be used to assess the mother's perception of the parent-child relationship. Higher scores represent a more positive perception of certain aspects of the parent-child relationship. The research team will undertake the Chinese translation process. This inventory will be filled in by mothers.

次要结局

  • Change of Baseline Mothers' Positive and Negative Affect level at 2 months, 5 months, and 8 months(Baseline, Month 2, Month 5, Month 8)
  • Change of Baseline Children's Mood States at 2 months, 5 months, and 8 months(Baseline, Month 2, Month 5, Month 8)
  • Change of Baseline Children's Behavioral and Emotional Problem at 2 months, 5 months,(Baseline, Month 2, Month 5, Month 8)
  • Change of Baseline Mothers' Quality of Life level at 2 months, 5 months, and 8 months(Baseline, Month 2, Month 5, Month 8)
  • Change of Baseline Mothers' Psychological Well-being at 2 months, 5 months, and 8 months(Baseline, Month 2, Month 5, Month 8)
  • Change of Baseline Children's Emotional Expression at 2 months, 5 months, and 8 months(Baseline, Month 2, Month 5, Month 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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