Occupational Performance Coaching With Parents of Young Children With Developmental Disability

Developmental Disability Clinical Trial

Official title:

A Parent-Coaching Intervention to Promote Community Participation of Young Children With Developmental Disability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04796909
• Other study ID #: ZC2Q
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: August 2022
• Source: The Hong Kong Polytechnic University
• Contact: Chi-Wen Chien, PhD
• Phone: +852-27666703
• Email: will.chien[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 83 Months

Eligibility

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)

Related Conditions & MeSH terms

• Developmental Disabilities
• Developmental Disability

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Christian Service	Kowloon
Hong Kong	Heep Hong Society	Kwun Tong
Hong Kong	SAHK	North Point

Sponsors (4)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Food and Health Bureau, Hong Kong, National Cheng Kung University, University of Otago

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Number of participants recruited	The percentage of eligible families agreeing to participate in the study	Through study completion, 1 year
Other	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
Other	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
Other	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
Other	Fidelity of coaches who conduct the Occupational Performance Coaching	Percentage score of the Occupational Performance Coaching Fidelity Measure	Through study completion, 1 year
Primary	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
Primary	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	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
Secondary	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
Secondary	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