Occupational Performance Coaching With Parents of Young Children With Developmental Disability

NCT ID: NCT04796909

Last Updated: 2025-04-23

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-02-28

Brief Summary

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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

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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

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Developmental Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Parent coaching

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

Group Type EXPERIMENTAL

Occupational Performance coaching

Intervention Type BEHAVIORAL

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 consultation

The parent consultations are given for up to 8 weekly/fortnightly sessions, and each session may last up to one hour.

Group Type ACTIVE_COMPARATOR

Parent consultation

Intervention Type BEHAVIORAL

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.

Interventions

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Occupational Performance coaching

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.

Intervention Type BEHAVIORAL

Parent consultation

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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OPC

Eligibility Criteria

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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)
Minimum Eligible Age

24 Months

Maximum Eligible Age

83 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Food and Health Bureau, Hong Kong

OTHER_GOV

Sponsor Role collaborator

University of Otago

OTHER

Sponsor Role collaborator

National Cheng Kung University

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chi-Wen Chien

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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Hong Kong Christian Service

Kowloon, , Hong Kong

Site Status

Heep Hong Society

Kwun Tong, , Hong Kong

Site Status

SAHK

North Point, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 34805034 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ZC2Q

Identifier Type: -

Identifier Source: org_study_id

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