Occupational Performance Coaching With Parents of Young Children With Developmental Disability

April 6, 2025 updated by: The Hong Kong Polytechnic University

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kowloon, Hong Kong
        • Hong Kong Christian Service
      • Kwun Tong, Hong Kong
        • Heep Hong Society
      • North Point, Hong Kong
        • SAHK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parent coaching
The parent-coaching intervention consists of up to 8 weekly/fortnightly sessions, and each session will last up to one hour.
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.
Other Names:
  • OPC
Active Comparator: Parent consultation
The parent consultations are given for up to 8 weekly/fortnightly sessions, and each session may last up to one hour.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Efficacy scores (7-42) and satisfaction scores (9-56) of the Parenting Sense of Competence Scale (PSOC). Higher scores mean a better outcome.
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
The scores (0-42 for each subscale) of the Depression, Anxiety and Stress Scale-21 (DASS-21). Higher scores mean a worse outcome.
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
Psychosocial health score (0-100) of the KINDL questionnaire. Higher scores mean a better outcome.
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability in Children's Daily Activity and Social/Cognitive Function
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
Scaled scores (0-100) of the daily activity and social/cognitive domains of the Pediatric Evaluation of Disability Inventory computer-adaptive tests (PEDI-CAT). Higher scores mean a better outcome.
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
Stability in Perceived Impact of Environmental Support on Children's Community Participation
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
Perceived environmental support scores (0-100) of the community section of the Young Children's Participation and Environment Measure. Higher scores mean a better outcome.
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
Level of Therapeutic Alliance During Coaching Session
Time Frame: Immediate after each of the coaching sessions during the intervention period
Total scores (0-40) of the Session Rating Scale (SRS). Higher average scores mean a better outcome.
Immediate after each of the coaching sessions during the intervention period
Level of Perceptions of Health Care Practitioners' Autonomy Support
Time Frame: T1=1-2 weeks before intervention; T2=1-2 weeks after intervention
Total scores (1-7) of the Health Care Climate Questionnaire (HCCQ). Higher scores mean a better outcome.
T1=1-2 weeks before intervention; T2=1-2 weeks after intervention
Level of Parents' Global Impression on the Improvement of Their Child's Community Participation
Time Frame: T2=1-2 weeks after intervention
The item score (1-7) of the Patient Global Impression of Change. Higher scores mean a worse outcome.
T2=1-2 weeks after intervention
Number of Participants Recruited
Time Frame: T0=5-6 weeks before intervention
The percentage of eligible families agreeing to participate in the study
T0=5-6 weeks before intervention
Retention Rate of Participants Who Complete the Trial
Time Frame: T3=8-9 weeks after the intervention
The percentage of participants who complete the trial (i.e., all assessments)
T3=8-9 weeks after the intervention
Adherence Rate of Participants Who Attend the Coaching Sessions
Time Frame: T2=1-2 weeks after intervention
The percentage of coaching sessions attended by parents who are randomized to the intervention group
T2=1-2 weeks after intervention
Blinding Success
Time Frame: T2=1-2 weeks after intervention
The percentage of parents who guess treatment allocation correctly after the study
T2=1-2 weeks after intervention
Fidelity of Coaches Who Conduct the Occupational Performance Coaching
Time Frame: T2=1-2 weeks after intervention
Percentage score of the Occupational Performance Coaching Fidelity Measure. This measure consists of 18 items across five domains: relationship, goal, reflection, analysis and action, client response, and distinguishing. Each item is rated on a three-point Likert scale (1 = low and 3 = high). The percentage score can be calculated by dividing the total score by the possible maximum score. Higher percentage scores indicate higher fidelity, and the cut-off of sufficient fidelity of coaching per session is set at 80%.
T2=1-2 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chi-Wen Chien, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ZC2Q

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Developmental Disability

Clinical Trials on Occupational Performance coaching

Subscribe