NCT04796909

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 23, 2025

Completed
Last Updated

April 23, 2025

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

March 10, 2021

Results QC Date

February 27, 2024

Last Update Submit

April 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    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

    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 Outcomes (10)

  • Stability in Children's Daily Activity and Social/Cognitive Function

    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

    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

    Immediate after each of the coaching sessions during the intervention period

  • +7 more other outcomes

Study Arms (2)

Parent coaching

EXPERIMENTAL

The parent-coaching intervention consists of up to 8 weekly/fortnightly sessions, and each session will last up to one hour.

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.

Behavioral: Parent consultation

Interventions

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.

Also known as: OPC
Parent coaching

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.

Parent consultation

Eligibility Criteria

Age24 Months - 83 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hong Kong Christian Service

Kowloon, Hong Kong

Location

Heep Hong Society

Kwun Tong, Hong Kong

Location

SAHK

North Point, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Limitations and Caveats

The COVID-19 pandemic posed significant challenges, impacting the intervention delivery and outcomes across all measures. The study's sample size was small and also excluded children with physical impairments. Two therapists fell short of achieving the stipulated 80% coaching fidelity in their initial cases and were not assigned further cases. Convenience sampling was used for participant recruitment, and families who chose to participate might have higher motivation.

Results Point of Contact

Title
Dr. Chi-Wen Chien, Associate Professor
Organization
The Hong Kong Polytechnic University

Study Officials

  • Chi-Wen Chien

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 15, 2021

Study Start

August 1, 2021

Primary Completion

December 31, 2022

Study Completion

February 28, 2023

Last Updated

April 23, 2025

Results First Posted

April 23, 2025

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations