Intellectual DisabilityNCT05214859
Enhancing Mother-Child Ties and Psychosocial Wellness Through Arts Among Children With Intellectual Disability and Their Mothers
A study testing The Dyadic Expressive Arts Group Therapy in people with Intellectual Disability and Mother-Child Relations, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intellectual Disability, Mother-Child Relations
- What is being tested?
- The Dyadic Expressive Arts Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Jul 2022to 31 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Intellectual Disability, Mother-Child Relations
- Being tested
- The Dyadic Expressive Arts Group Therapy
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Dyadic Expressive Arts Group TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention arm will receive Dyadic Expressive Arts Group Therapy as an intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
The Chinese validated version of the International Positive and Negative Affectivity Schedule - Short Form will be used to assess the level of positive and negative affectivity of mothers. The scale yields two scores indicating the level of positive and negative affect separately. Higher scores represent a higher level of positive or negative affect. This scale will be filled in by mothers.
Measured: Baseline, Month 2, Month 5, Month 8
Change of Baseline Mothers' Quality of Life level at 2 months, 5 months, and 8 months
The Hong Kong-Chinese validated version of the WHO Quality of Life Scale brief version will be used to assess the level of quality of life of mothers. Four main domains of Quality of Life will be assessed, including physical, psychological, social relationship, and environmental. Higher scores represent a higher level of quality of life. The scale will be filled in by mothers.
Measured: Baseline, Month 2, Month 5, Month 8
Change of Baseline Mothers' Psychological Well-being at 2 months, 5 months, and 8 months
The Hong Kong Cantonese validated version of The World Health Organisation- Five Well-Being Index (WHO-5) will be used to assess the level of psychological well-being of mothers. The scale yields a raw score and will be multiplied by 4 to yield a percentage score. Higher scores represent a higher level of psychological well-being. The scale will be filled in by mothers.
Measured: Baseline, Month 2, Month 5, Month 8
Change of Baseline Children's Mood States at 2 months, 5 months, and 8 months
The Ottawa Mood Scales will be adopted to assess the mood states of children with intellectual disabilities. The scale composes of 5 items that assess the level of mood, anger, worry, stress, and self-regulation. Visual clues, such as schematic faces, numerical scales, and thermometer icons, are included for facilitating the understanding. The research team will undertake the Chinese translation process. This inventory will be filled in by children with intellectual disabilities with assistance.
Measured: Baseline, Month 2, Month 5, Month 8
Change of Baseline Children's Emotional Expression at 2 months, 5 months, and 8 months
The Face Stimulus Assessment will be utilized to assess the level of emotional expression of children with intellectual disabilities. The assessment contains a series of three A4-size stimulus drawing templates: the first is a pre-drawn face, the second is a face outline, and the third is a blank sheet of paper. Participants will be asked to use the markers provided on the templates individually. The whole process and the sketches will be assessed through a quantitative and qualitative approach following guidelines from the FSA E-Packet and Rating Manual (2nd ed.)The sketches will also be scanned to analyze the pattern of color usage. This assessment will be filled in by children with intellectual disabilities with assistance.
Measured: Baseline, Month 2, Month 5, Month 8
Change of Baseline Children's Behavioral and Emotional Problem at 2 months, 5 months,
The Hong Kong-Chinese authorized version of the Child Behavior Checklist (Teachers' Report Form) will be used to assess the level of Behavioral and Emotional Problems of children with intellectual disabilities. The checklist yields three scores on externalizing, internalizing, and total behavioral problems, and eight syndromes are withdrawn, somatic complaints, anxious/depressed, thought problems, social problems, attention problems, delinquent behaviors, and aggressive behavior. Higher scores indicate greater manifestations of that area of behavioral and emotional problems. The checklist will be filled in by corresponding teachers or social workers.
Measured: Baseline, Month 2, Month 5, Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start9 Jul 2022
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Chi Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214859
- Sponsor's protocol ID
- EA200329
- Status last verified
- May 2026
- First submitted
- 3 Jan 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37419633
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05214859
- Acronym / sponsor ID
- EA200329
- Conditions
- Intellectual Disability, Mother-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Chi Association
- Study start
- 9 Jul 2022 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 31 Jan 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: The Dyadic Expressive Arts Group TherapyParticipants in the intervention arm will receive Dyadic Expressive Arts Group Therapy as an intervention. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| The Dyadic Expressive Arts Group TherapyThis 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. | Behavioural | Intervention |
Primary outcome
Change of Baseline Mothers' Parenting Stress level at 2 months, 5 months, and 8 months
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Change of Baseline Mothers' Positive and Negative Affect level at 2 months, 5 months, and 8 months
Time frame: Baseline, Month 2, Month 5, Month 8
Change of Baseline Mothers' Quality of Life level at 2 months, 5 months, and 8 months
Time frame: Baseline, Month 2, Month 5, Month 8
Change of Baseline Mothers' Psychological Well-being at 2 months, 5 months, and 8 months
Time frame: Baseline, Month 2, Month 5, Month 8
Change of Baseline Children's Mood States at 2 months, 5 months, and 8 months
Time frame: Baseline, Month 2, Month 5, Month 8
Change of Baseline Children's Emotional Expression at 2 months, 5 months, and 8 months
Time frame: Baseline, Month 2, Month 5, Month 8
Change of Baseline Children's Behavioral and Emotional Problem at 2 months, 5 months,
Time frame: Baseline, Month 2, Month 5, Month 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 37419633Lo 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Dyadic Expressive Arts Group Therapy in people with Intellectual Disability and Mother-Child Relations, run by The University of Hong Kong at 1 site in Hong Kong.
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 0 inclusion and 2 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: finished, as of the sponsor's last update on 15 May 2026. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Baseline Mothers' Parenting Stress level at 2 months, 5 months, and 8 months (time frame: Baseline, Month 2, Month 5, Month 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05214859, which also lists 1 linked publication.
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 15 May 2026.