Occupational Performance Coaching With Parents of Young Children With Developmental Disability

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

• Status: Recruiting
• Conditions: Developmental Disability
• Intervention / Treatment: Behavioral: Occupational Performance coaching; Behavioral: Parent consultation

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chi-Wen Chien, PhD; Phone Number: +852-27666703; Email: will.chien@polyu.edu.hk

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Recruiting
    • Hong Kong Christian Service
    • Contact: Winnie Fung
  • Kwun Tong, Hong Kong
    • Recruiting
    • Heep Hong Society
    • Contact: Lousia Lai
  • North Point, Hong Kong
    • Recruiting
    • SAHK
    • Contact: Yonnie Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	Behavioral: 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.; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in participation-related goal performance and satisfaction	Performance and satisfaction scores (1-10) of the Canadian Occupational Performance Measure. Higher scores mean a better outcome.	5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 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. Higher scores mean a better outcome.	5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parenting efficacy and satisfaction	Efficacy scores (7-42) and satisfaction scores (9-56) of the Parenting Sense of Competence Scale. Higher scores mean a better outcome.	5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention
Change in parents' negative emotional states	The scores (0-21 for each subscale) of the Depression, Anxiety and Stress Scale-21. Higher scores mean a worse outcome.	5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 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.	5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 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	Scaled scores (0-100) of the daily activity and social/cognitive domains of the Pediatric Evaluation of Disability Inventory computer-adaptive tests. Higher scores mean a better outcome.	5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention
Stability in perceived impact of environmental support on children's community participation	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.	5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention
Level of therapeutic alliance during coaching session	Total scores (0-10) of the Session Rating Scale. Higher scores mean a better outcome.	Immediate after each of the coaching sessions
Level of perceptions of health care practitioners' autonomy support	Total scores (1-7) of the Health Care Climate Questionnaire. Higher scores mean a better outcome.	1-2 weeks before intervention; 1-2 weeks after intervention
Level of parents' global impression on the improvement of their child's community participation	The item score (1-7) of the Patient Global Impression of Change. Higher scores mean a worse outcome.	1-2 weeks after intervention
Number of participants recruited	The percentage of eligible families agreeing to participate in the study	Through study completion, 1 year
Retention rate of participants who complete the trial	The percentage of participants who complete the trial (i.e., all assessments)	Through study completion, 1 year
Adherence rate of participants who attend the coaching sessions	The percentage of coaching sessions attended by parents who are randomized to the intervention group	Through study completion, 1 year
Blinding success of participants who are allocated in the intervention and control groups	The percentage of parents who guess treatment allocation correctly after the study	1-2 weeks after intervention
Fidelity of coaches who conduct the Occupational Performance Coaching	Percentage score of the Occupational Performance Coaching Fidelity Measure	Through study completion, 1 year

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: University of Otago; Food and Health Bureau, Hong Kong; National Cheng Kung University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): December 21, 2022

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): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• 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