Clinical trial NCT04796909: 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
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Disability
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
name: University of Otago
name: National Cheng Kung University
First posted: 2021-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 24
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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)

Primary outcomes:
measure: Change in Participation-related Goal Performance and Satisfaction
timeFrame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
measure: Change in Children's Community Participation Frequency and Involvement
timeFrame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Secondary outcomes:
measure: Change in Parenting Efficacy and Satisfaction
timeFrame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
measure: Change in Parents' Negative Emotional States
timeFrame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
measure: Change in Children's Psychosocial Health
timeFrame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
Other outcomes:
measure: Stability in Children's Daily Activity and Social/Cognitive Function
timeFrame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
measure: Stability in Perceived Impact of Environmental Support on Children's Community Participation
timeFrame: T0=5-6 weeks before intervention; T1=1-2 weeks before intervention; T2=1-2 weeks after intervention; T3=8-9 weeks after the intervention
measure: Level of Therapeutic Alliance During Coaching Session
timeFrame: Immediate after each of the coaching sessions during the intervention period
measure: Level of Perceptions of Health Care Practitioners' Autonomy Support
timeFrame: T1=1-2 weeks before intervention; T2=1-2 weeks after intervention
measure: Level of Parents' Global Impression on the Improvement of Their Child's Community Participation
timeFrame: T2=1-2 weeks after intervention
measure: Number of Participants Recruited
timeFrame: T0=5-6 weeks before intervention
measure: Retention Rate of Participants Who Complete the Trial
timeFrame: T3=8-9 weeks after the intervention
measure: Adherence Rate of Participants Who Attend the Coaching Sessions
timeFrame: T2=1-2 weeks after intervention
measure: Blinding Success
timeFrame: T2=1-2 weeks after intervention
measure: Fidelity of Coaches Who Conduct the Occupational Performance Coaching
timeFrame: T2=1-2 weeks after intervention
Locations:
city: Kowloon
country: Hong Kong
facility: Hong Kong Christian Service
city: Kwun Tong
country: Hong Kong
facility: Heep Hong Society
city: North Point
country: Hong Kong
facility: SAHK
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Chi-Wen Chien
role: PRINCIPAL_INVESTIGATOR
References:
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.