NCT05214859

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 9, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

3.5 years

First QC Date

January 3, 2022

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

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

    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.

    Baseline, Month 2, Month 5, Month 8

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

    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.

    Baseline, Month 2, Month 5, Month 8

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

    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.

    Baseline, Month 2, Month 5, Month 8

Secondary Outcomes (6)

  • 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 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 Mood States 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

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: The Dyadic Expressive Arts Group Therapy

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.

Interventions

This therapy utilizes different art modalities, such as visual art, music, movement, dance, drama, and writing, as therapeutic means. With multiple sensory stimulations from different art forms, the therapy facilitates communication, expression, perception, and interactions. The therapy consists of 8 weekly 90 minutes sessions, with 3-4 mother-child dyads in each therapy group. Each session will follow the basic structure of Expressive Arts Therapy, including check-in, warm-up, core art-making, sharing, and closure. The following themes related to the mother-child relationship will be included, such as communication, relationship, expression, empathy, interaction, love, gratitude, and connection.

Intervention

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsOnly mothers are eligible for this study
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre on Behavioral Health HKU

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Lo TLT, Wan AHY, Fong TCT, Wong PKS, Lo HHM, Chan CKP, Ho RTH. Protocol for a mixed-methods randomised controlled trial evaluating the effectiveness of a dyadic expressive arts-based intervention in improving the psychosocial well-being of children with intellectual disability in special schools and their mothers. BMJ Open. 2023 Jul 7;13(7):e067239. doi: 10.1136/bmjopen-2022-067239.

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Rainbow Ho

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 31, 2022

Study Start

July 9, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The data that support the findings of this study are available from the principal investigator upon reasonable request. The data are not publicly available due to it involves personal and clinical data from children with intellectual disability and their mothers.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
3 years after the completion of the study
Access Criteria
The principal investigator will review each request and decide if data will be available to other researchers.

Locations