Occupational Performance Coaching With Parents of Young Children With Developmental Disability
Primary Purpose
Developmental Disability
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Occupational Performance coaching
Parent consultation
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Disability
Eligibility Criteria
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)
Sites / Locations
- Hong Kong Christian ServiceRecruiting
- Heep Hong SocietyRecruiting
- SAHKRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parent coaching
Parent consultation
Arm Description
The parent-coaching intervention consists of up to 8 weekly/fortnightly sessions, and each session will last up to one hour.
The parent consultations are given for up to 8 weekly/fortnightly sessions, and each session may last up to one hour.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Change in children's psychosocial health
Psychosocial health score (0-100) of the KINDL questionnaire. Higher scores mean a better outcome.
Full Information
NCT ID
NCT04796909
First Posted
March 10, 2021
Last Updated
March 7, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
Food and Health Bureau, Hong Kong, University of Otago, National Cheng Kung University
1. Study Identification
Unique Protocol Identification Number
NCT04796909
Brief Title
Occupational Performance Coaching With Parents of Young Children With Developmental Disability
Official Title
A Parent-Coaching Intervention to Promote Community Participation of Young Children With Developmental Disability
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Food and Health Bureau, Hong Kong, University of Otago, National Cheng Kung University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parent coaching
Arm Type
Experimental
Arm Description
The parent-coaching intervention consists of up to 8 weekly/fortnightly sessions, and each session will last up to one hour.
Arm Title
Parent consultation
Arm Type
Active Comparator
Arm Description
The parent consultations are given for up to 8 weekly/fortnightly sessions, and each session may last up to one hour.
Intervention Type
Behavioral
Intervention Name(s)
Occupational Performance coaching
Other Intervention Name(s)
OPC
Intervention Description
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
Intervention Name(s)
Parent consultation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in participation-related goal performance and satisfaction
Description
Performance and satisfaction scores (1-10) of the Canadian Occupational Performance Measure. Higher scores mean a better outcome.
Time Frame
5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention
Title
Change in children's community participation frequency and involvement
Description
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.
Time Frame
5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention
Secondary Outcome Measure Information:
Title
Change in parenting efficacy and satisfaction
Description
Efficacy scores (7-42) and satisfaction scores (9-56) of the Parenting Sense of Competence Scale. Higher scores mean a better outcome.
Time Frame
5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention
Title
Change in parents' negative emotional states
Description
The scores (0-21 for each subscale) of the Depression, Anxiety and Stress Scale-21. Higher scores mean a worse outcome.
Time Frame
5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention
Title
Change in children's psychosocial health
Description
Psychosocial health score (0-100) of the KINDL questionnaire. Higher scores mean a better outcome.
Time Frame
5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention
Other Pre-specified Outcome Measures:
Title
Stability in children's daily activity and social/cognitive function
Description
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.
Time Frame
5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention
Title
Stability in perceived impact of environmental support on children's community participation
Description
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.
Time Frame
5-6 weeks before intervention; 1-2 weeks before intervention; 1-2 weeks after intervention; 8-9 weeks after the intervention
Title
Level of therapeutic alliance during coaching session
Description
Total scores (0-10) of the Session Rating Scale. Higher scores mean a better outcome.
Time Frame
Immediate after each of the coaching sessions
Title
Level of perceptions of health care practitioners' autonomy support
Description
Total scores (1-7) of the Health Care Climate Questionnaire. Higher scores mean a better outcome.
Time Frame
1-2 weeks before intervention; 1-2 weeks after intervention
Title
Level of parents' global impression on the improvement of their child's community participation
Description
The item score (1-7) of the Patient Global Impression of Change. Higher scores mean a worse outcome.
Time Frame
1-2 weeks after intervention
Title
Number of participants recruited
Description
The percentage of eligible families agreeing to participate in the study
Time Frame
Through study completion, 1 year
Title
Retention rate of participants who complete the trial
Description
The percentage of participants who complete the trial (i.e., all assessments)
Time Frame
Through study completion, 1 year
Title
Adherence rate of participants who attend the coaching sessions
Description
The percentage of coaching sessions attended by parents who are randomized to the intervention group
Time Frame
Through study completion, 1 year
Title
Blinding success of participants who are allocated in the intervention and control groups
Description
The percentage of parents who guess treatment allocation correctly after the study
Time Frame
1-2 weeks after intervention
Title
Fidelity of coaches who conduct the Occupational Performance Coaching
Description
Percentage score of the Occupational Performance Coaching Fidelity Measure
Time Frame
Through study completion, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
83 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi-Wen Chien, PhD
Phone
+852-27666703
Email
will.chien@polyu.edu.hk
Facility Information:
Facility Name
Hong Kong Christian Service
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winnie Fung
Facility Name
Heep Hong Society
City
Kwun Tong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lousia Lai
Facility Name
SAHK
City
North Point
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonnie Yu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34805034
Citation
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.
Results Reference
derived
Learn more about this trial
Occupational Performance Coaching With Parents of Young Children With Developmental Disability
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