Clinical trial NCT05214859: Enhancing Mother-Child Ties and Psychosocial Wellness Through Arts Among Children With Intellectual Disability and Their Mothers
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability
Mother-Child Relations
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Chi Association
First posted: 2022-01-31
Enrollment: 154
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change of Baseline Mothers' Parenting Stress level at 2 months, 5 months, and 8 months
timeFrame: Baseline, Month 2, Month 5, Month 8
measure: Change of Baseline Mothers' Burnout level at 2 months, 5 months, and 8 months
timeFrame: Baseline, Month 2, Month 5, Month 8
measure: Change of Baseline Mothers' perceive Parent-Child Relationship at 2 months, 5 months, and 8 months
timeFrame: Baseline, Month 2, Month 5, Month 8
Secondary outcomes:
measure: Change of Baseline Mothers' Positive and Negative Affect level at 2 months, 5 months, and 8 months
timeFrame: Baseline, Month 2, Month 5, Month 8
measure: Change of Baseline Mothers' Quality of Life level at 2 months, 5 months, and 8 months
timeFrame: Baseline, Month 2, Month 5, Month 8
measure: Change of Baseline Mothers' Psychological Well-being at 2 months, 5 months, and 8 months
timeFrame: Baseline, Month 2, Month 5, Month 8
measure: Change of Baseline Children's Mood States at 2 months, 5 months, and 8 months
timeFrame: Baseline, Month 2, Month 5, Month 8
measure: Change of Baseline Children's Emotional Expression at 2 months, 5 months, and 8 months
timeFrame: Baseline, Month 2, Month 5, Month 8
measure: Change of Baseline Children's Behavioral and Emotional Problem at 2 months, 5 months,
timeFrame: Baseline, Month 2, Month 5, Month 8
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre on Behavioral Health HKU
Study officials:
References: