Occupational Performance Coaching With Parents of Young Children With Developmental Disability

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04796909
Collaborator
Food and Health Bureau, Hong Kong (Other), University of Otago (Other), National Cheng Kung University (Other)
50
3
2
16.7
16.7
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Occupational Performance coaching
  • Behavioral: Parent consultation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Parent-Coaching Intervention to Promote Community Participation of Young Children With Developmental Disability
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Dec 21, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in participation-related goal performance and satisfaction [5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention]

      Performance and satisfaction scores (1-10) of the Canadian Occupational Performance Measure. Higher scores mean a better outcome.

    2. Change in children's community participation frequency and involvement [5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 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. Higher scores mean a better outcome.

    Secondary Outcome Measures

    1. Change in parenting efficacy and satisfaction [5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention]

      Efficacy scores (7-42) and satisfaction scores (9-56) of the Parenting Sense of Competence Scale. Higher scores mean a better outcome.

    2. Change in parents' negative emotional states [5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention]

      The scores (0-21 for each subscale) of the Depression, Anxiety and Stress Scale-21. Higher scores mean a worse outcome.

    3. Change in children's psychosocial health [5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention]

      Psychosocial health score (0-100) of the KINDL questionnaire. Higher scores mean a better outcome.

    Other Outcome Measures

    1. Stability in children's daily activity and social/cognitive function [5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 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. Higher scores mean a better outcome.

    2. Stability in perceived impact of environmental support on children's community participation [5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 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.

    3. Level of therapeutic alliance during coaching session [Immediate after each of the coaching sessions]

      Total scores (0-10) of the Session Rating Scale. Higher scores mean a better outcome.

    4. Level of perceptions of health care practitioners' autonomy support [1-2 weeks before intervention; 1-2 weeks after intervention]

      Total scores (1-7) of the Health Care Climate Questionnaire. Higher scores mean a better outcome.

    5. Level of parents' global impression on the improvement of their child's community participation [1-2 weeks after intervention]

      The item score (1-7) of the Patient Global Impression of Change. Higher scores mean a worse outcome.

    6. Number of participants recruited [Through study completion, 1 year]

      The percentage of eligible families agreeing to participate in the study

    7. Retention rate of participants who complete the trial [Through study completion, 1 year]

      The percentage of participants who complete the trial (i.e., all assessments)

    8. Adherence rate of participants who attend the coaching sessions [Through study completion, 1 year]

      The percentage of coaching sessions attended by parents who are randomized to the intervention group

    9. Blinding success of participants who are allocated in the intervention and control groups [1-2 weeks after intervention]

      The percentage of parents who guess treatment allocation correctly after the study

    10. Fidelity of coaches who conduct the Occupational Performance Coaching [Through study completion, 1 year]

      Percentage score of the Occupational Performance Coaching Fidelity Measure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Months to 83 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hong Kong Christian Service Kowloon Hong Kong
    2 Heep Hong Society Kwun Tong Hong Kong
    3 SAHK North Point Hong Kong

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Hong Kong Polytechnic University
    ClinicalTrials.gov Identifier:
    NCT04796909
    Other Study ID Numbers:
    • ZC2Q
    First Posted:
    Mar 15, 2021
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 18, 2022