Developmental DisabilityNCT04796909
Occupational Performance Coaching With Parents of Young Children With Developmental Disability
A study testing Occupational Performance coaching and Parent consultation in people with Developmental Disability, run by The Hong Kong Polytechnic University at 3 sites in Hong Kong.
Trial summary
Participation in community activities allows children to meet friends, learns new skills, fosters independence, and paves the foundation for lifelong health. High rates of community participation restriction have been reported in children with developmental disabilities who are aged six years or below, a critical… Read more about this study
- Who is it for?
- Ages 24 to 83 months
- Conditions the study is for
- Developmental Disability
- What is being tested?
- Occupational Performance coaching and Parent consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesHong Kong
- Study dates
- 1 Aug 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 to 83 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the child has a clinical diagnosis of developmental disability (including but not limited to intellectual disability, developmental delay, or autism spectrum disorder) given by pediatricians/psychiatrist
- the parents are the child's main caregiver who have a long-term parenting role with at least 50% of caregiving responsibilities
- the parents are able to converse in Chinese
- the parents desire to improve their child's participation in community activities
Who cannot join
- the child has developmental disability combined with physical impairment (e.g., amputation, cerebral palsy, spina bifida)
- the child has developmental disability combined with sensory impairment (e.g., blindness, deafness)
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Hong Kong Christian Service
Kowloon
Heep Hong Society
Kwun Tong
SAHK
North Point
About this study
Official title: A Parent-Coaching Intervention to Promote Community Participation of Young Children With Developmental Disability
Participation in community activities allows children to meet friends, learns new skills, fosters independence, and paves the foundation for lifelong health. High rates of community participation restriction have been reported in children with developmental disabilities who are aged six years or below, a critical developmental period.
Occupational Performance Coaching (OPC), grounded in self-determination theory, is aimed to facilitate children's participation in life situations through coaching parents. Studies have shown that OPC is effective to promote children's activity participation. However, there have been limited randomized controlled trials demonstrating the efficacy of OPC, especially with the specific focus on children's community participation.
The investigators propose to evaluate the feasibility and acceptability of conducting a pilot randomized controlled trial of OPC for parents of preschool children with developmental disabilities in Hong Kong, and to test its initial efficacy on promoting children's community participation.
Read the detailed description
Parent coaching emerges as a preferred approach for enhancing performance and participation of children with developmental disabilities (DD), but limited clinical trials examine its effects on community participation. Thus, this study aims to evaluate whether parent coaching, specifically using Occupational Performance Coaching (OPC), enhances community participation among young children with DD.
Young children with DD will be recruited from preschool-rehabilitation services offered by three non-governmental organisations in Hong Kong. Ethics approval has been obtained from the Human Subjects Ethics Sub-committee at The Hong Kong Polytechnic University.
A two-arm parallel, double-blind design will be adopted for the study. Fifty parents of young children with DD will be randomly assigned to the intervention group (i.e., OPC) or the active control group (i.e., parents' consultation). Four assessment points will be scheduled throughout the study: 5-6 weeks before intervention (Time 0), 1-2 weeks before intervention (Time 1), 1-2 weeks after intervention (Time 2), and 8-9 weeks after the intervention (Time 3). Randomisation allocation will be completed at Time 1. Participants and independent outcome assessors will not be informed about the groupings.
Each parent will receive a maximum of eight coaching sessions or consultations. The primary outcome will be children's community participation as assessed through parent-report measures at baseline, pre-intervention, post-intervention, and an 8-week follow-up. Children in both groups will continue to receive their usual care, which may include services such as occupational therapy, physiotherapy, and speech therapy on a weekly/monthly basis, depending on their individual needs.
Independent t-test and chi-square statistics will be used to test for between-group baseline differences. To evaluate the effect of OPC on each outcome measure, repeated-measures analysis of covariance (ANCOVA) by controlling for baseline values per outcome will be used. Post-hoc analyses will be performed when the main effects were significant. Statistical significance is set at p < 0.05. Estimates of effect sizes with 95% confidence intervals will be calculated for each outcome measure.
- Conditions
- Developmental Disability
- Being tested
- Occupational Performance coaching, Parent consultation
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Performance coachingBehavioural
Also called OPC
The OPC intervention comprises three components: (1) connect - building parents' trust in the coach by using verbal and nonverbal strategies; (2) structure - building parents' competence by adopting a problem-solving framework of setting goals, exploring options, planning action, carrying out plans, checking performance, and generalizing; and (3) share - building parents' autonomy by reciprocally exchanging information between the coach and parents with an emphasis on eliciting parents existing knowledge. During the exploration of the options for a particular goal, collaborative performance analysis is used. The coach follows the four steps to (a) identify parents' perception of what currently happens, (b) identify what they would like to happen, (c) explore barriers and bridges to the desired performance, and (d) identify their needs for taking actions to achieve goals. Parents are guided to find strategies to facilitate their child's performance to support goal achievement.
Parent consultationBehavioural
The parent consultation consists of the use of the toolbox to provide parents with available environmental resources and strategies to enhance community participation of their child with developmental disability, followed by the understanding of current situation and the identification of problems encountered by parents. Direct informing approach will be used to instruct parents about the availability of environmental resources close to their living areas and what they can plan to do by using possible supportive strategies. In addition, information about child disability and/or developmental milestone may be provided if needed.
| Study group | Role | What they receive |
|---|---|---|
| Parent coaching | Experimental | The parent-coaching intervention consists of up to 8 weekly/fortnightly sessions, and each session will last up to one hour. Receives: Behavioral: Occupational Performance coaching |
| Parent consultation | Active comparator | The parent consultations are given for up to 8 weekly/fortnightly sessions, and each session may last up to one hour. Receives: Behavioral: Parent consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Participation-related Goal Performance and Satisfaction
Performance and satisfaction scores (1-10) of the Canadian Occupational Performance Measure (COPM). Higher scores mean a better outcome.
Measured: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Change in Children's Community Participation Frequency and Involvement
Frequency scores (0-7) and involvement scores (1-5) of the community section of the Young Children's Participation and Environment Measure (YC-PEM). Higher scores mean a better outcome.
Measured: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Secondary outcomes (3)
Change in Parenting Efficacy and Satisfaction
Efficacy scores (7-42) and satisfaction scores (9-56) of the Parenting Sense of Competence Scale (PSOC). Higher scores mean a better outcome.
Measured: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Change in Parents' Negative Emotional States
The scores (0-42 for each subscale) of the Depression, Anxiety and Stress Scale-21 (DASS-21). Higher scores mean a worse outcome.
Measured: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Change in Children's Psychosocial Health
Psychosocial health score (0-100) of the KINDL questionnaire. Higher scores mean a better outcome.
Measured: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Aug 2021
- Primary completion31 Dec 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong, University of Otago, National Cheng Kung University
- Responsible party
- Sponsor
- Investigators
- Chi-Wen Chien, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796909
- Sponsor's protocol ID
- ZC2Q
- Status last verified
- Aug 2022
- First submitted
- 10 Mar 2021
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chien CW, Lai YYC, Lin CY, Graham F. Occupational Performance Coaching With Parents to Promote Community Participation of Young Children With Developmental Disabilities: Protocol for a Feasibility and Pilot Randomized Control Trial. Front Pediatr. 2021 Nov 5;9:720885. doi: 10.3389/fped.2021.720885. eCollection 2021.
PubMed 34805034
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parent-Coaching Intervention to Promote Community Participation of Young Children With Developmental Disability
- ClinicalTrials.gov ID
- NCT04796909
- Acronym / sponsor ID
- ZC2Q
- Conditions
- Developmental Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong, University of Otago, National Cheng Kung University
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participation in community activities allows children to meet friends, learns new skills, fosters independence, and paves the foundation for lifelong health. High rates of community participation restriction have been reported in children with developmental disabilities who are aged six years or below, a critical developmental period.
Occupational Performance Coaching (OPC), grounded in self-determination theory, is aimed to facilitate children's participation in life situations through coaching parents. Studies have shown that OPC is effective to promote children's activity participation. However, there have been limited randomized controlled trials demonstrating the efficacy of OPC, especially with the specific focus on children's community participation.
The investigators propose to evaluate the feasibility and acceptability of conducting a pilot randomized controlled trial of OPC for parents of preschool children with developmental disabilities in Hong Kong, and to test its initial efficacy on promoting children's community participation.
Detailed description
Parent coaching emerges as a preferred approach for enhancing performance and participation of children with developmental disabilities (DD), but limited clinical trials examine its effects on community participation. Thus, this study aims to evaluate whether parent coaching, specifically using Occupational Performance Coaching (OPC), enhances community participation among young children with DD.
Young children with DD will be recruited from preschool-rehabilitation services offered by three non-governmental organisations in Hong Kong. Ethics approval has been obtained from the Human Subjects Ethics Sub-committee at The Hong Kong Polytechnic University.
A two-arm parallel, double-blind design will be adopted for the study. Fifty parents of young children with DD will be randomly assigned to the intervention group (i.e., OPC) or the active control group (i.e., parents' consultation). Four assessment points will be scheduled throughout the study: 5-6 weeks before intervention (Time 0), 1-2 weeks before intervention (Time 1), 1-2 weeks after intervention (Time 2), and 8-9 weeks after the intervention (Time 3). Randomisation allocation will be completed at Time 1. Participants and independent outcome assessors will not be informed about the groupings.
Each parent will receive a maximum of eight coaching sessions or consultations. The primary outcome will be children's community participation as assessed through parent-report measures at baseline, pre-intervention, post-intervention, and an 8-week follow-up. Children in both groups will continue to receive their usual care, which may include services such as occupational therapy, physiotherapy, and speech therapy on a weekly/monthly basis, depending on their individual needs.
Independent t-test and chi-square statistics will be used to test for between-group baseline differences. To evaluate the effect of OPC on each outcome measure, repeated-measures analysis of covariance (ANCOVA) by controlling for baseline values per outcome will be used. Post-hoc analyses will be performed when the main effects were significant. Statistical significance is set at p < 0.05. Estimates of effect sizes with 95% confidence intervals will be calculated for each outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent coaching | Experimental | Behavioral: Occupational Performance coachingThe parent-coaching intervention consists of up to 8 weekly/fortnightly sessions, and each session will last up to one hour. |
| Parent consultation | Active comparator | Behavioral: Parent consultationThe parent consultations are given for up to 8 weekly/fortnightly sessions, and each session may last up to one hour. |
Who may qualify
- Ages
- 24 to 83 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- the child has a clinical diagnosis of developmental disability (including but not limited to intellectual disability, developmental delay, or autism spectrum disorder) given by pediatricians/psychiatrist
- the parents are the child's main caregiver who have a long-term parenting role with at least 50% of caregiving responsibilities
- the parents are able to converse in Chinese
- the parents desire to improve their child's participation in community activities
Key exclusion criteria (2 listed)
- the child has developmental disability combined with physical impairment (e.g., amputation, cerebral palsy, spina bifida)
- the child has developmental disability combined with sensory impairment (e.g., blindness, deafness)
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 |
|---|---|---|
| Occupational Performance coachingAlso: OPCThe OPC intervention comprises three components: (1) connect - building parents' trust in the coach by using verbal and nonverbal strategies; (2) structure - building parents' competence by adopting a problem-solving framework of setting goals, exploring options, planning action, carrying out plans, checking performance, and generalizing; and (3) share - building parents' autonomy by reciprocally exchanging information between the coach and parents with an emphasis on eliciting parents existing knowledge. During the exploration of the options for a particular goal, collaborative performance analysis is used. The coach follows the four steps to (a) identify parents' perception of what currently happens, (b) identify what they would like to happen, (c) explore barriers and bridges to the desired performance, and (d) identify their needs for taking actions to achieve goals. Parents are guided to find strategies to facilitate their child's performance to support goal achievement. | Behavioural | Parent coaching |
| Parent consultationThe parent consultation consists of the use of the toolbox to provide parents with available environmental resources and strategies to enhance community participation of their child with developmental disability, followed by the understanding of current situation and the identification of problems encountered by parents. Direct informing approach will be used to instruct parents about the availability of environmental resources close to their living areas and what they can plan to do by using possible supportive strategies. In addition, information about child disability and/or developmental milestone may be provided if needed. | Behavioural | Parent consultation |
Primary outcome
Change in Participation-related Goal Performance and Satisfaction
Time frame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Performance and satisfaction scores (1-10) of the Canadian Occupational Performance Measure (COPM). Higher scores mean a better outcome.
Change in Children's Community Participation Frequency and Involvement
Time frame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Frequency scores (0-7) and involvement scores (1-5) of the community section of the Young Children's Participation and Environment Measure (YC-PEM). Higher scores mean a better outcome.
3 secondary outcomes
Change in Parenting Efficacy and Satisfaction
Time frame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Change in Parents' Negative Emotional States
Time frame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Change in Children's Psychosocial Health
Time frame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34805034Chien CW, Lai YYC, Lin CY, Graham F. Occupational Performance Coaching With Parents to Promote Community Participation of Young Children With Developmental Disabilities: Protocol for a Feasibility and Pilot Randomized Control Trial. Front Pediatr. 2021 Nov 5;9:720885. doi: 10.3389/fped.2021.720885. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Chi-Wen Chien principal investigator
The Hong Kong Polytechnic University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Performance coaching and Parent consultation in people with Developmental Disability, run by The Hong Kong Polytechnic University at 3 sites 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 4 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 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Participation-related Goal Performance and Satisfaction (time frame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention). The study lists 2 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 NCT04796909, 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 23 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.