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Completed

NCT Number: NCT04796909

Occupational Performance Coaching With Parents 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.

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Key information

Conditions

Developmental Disability Developmental Disabilities Mental Disorders Neurodevelopmental Disorders

Age range

24 month–83 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Christian Service, Kowloon, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Occupational Performance coaching

Behavioral

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

Parent consultation

Behavioral

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 outcomes

  1. Change in Participation-related Goal Performance and Satisfaction

    Time frame: 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

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

  2. Change in Children's Community Participation Frequency and Involvement

    Time frame: 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

    Frequency scores (0-7) and involvement scores (1-5) of the community section of the Young Children's Participation and Environment Measure (YC-PEM). Higher scores mean a better outcome.

Secondary outcomes

  1. Change in Parenting Efficacy and Satisfaction

    Time frame: 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

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

  2. Change in Parents' Negative Emotional States

    Time frame: 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

    The scores (0-42 for each subscale) of the Depression, Anxiety and Stress Scale-21 (DASS-21). Higher scores mean a worse outcome.

  3. Change in Children's Psychosocial Health

    Time frame: 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

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

Other outcomes

  1. Stability in Children's Daily Activity and Social/Cognitive Function

    Time frame: 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

    Scaled scores (0-100) of the daily activity and social/cognitive domains of the Pediatric Evaluation of Disability Inventory computer-adaptive tests (PEDI-CAT). Higher scores mean a better outcome.

  2. Stability in Perceived Impact of Environmental Support on Children's Community Participation

    Time frame: 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

    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

    Time frame: Immediate after each of the coaching sessions during the intervention period

    Total scores (0-40) of the Session Rating Scale (SRS). Higher average scores mean a better outcome.

  4. Level of Perceptions of Health Care Practitioners' Autonomy Support

    Time frame: T1=1-2 weeks before intervention; T2=1-2 weeks after intervention

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

  5. Level of Parents' Global Impression on the Improvement of Their Child's Community Participation

    Time frame: T2=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

    Time frame: T0=5-6 weeks before intervention

    The percentage of eligible families agreeing to participate in the study

  7. Retention Rate of Participants Who Complete the Trial

    Time frame: T3=8-9 weeks after the intervention

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

  8. Adherence Rate of Participants Who Attend the Coaching Sessions

    Time frame: T2=1-2 weeks after intervention

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

  9. Blinding Success

    Time frame: T2=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

    Time frame: T2=1-2 weeks after intervention

    Percentage score of the Occupational Performance Coaching Fidelity Measure. This measure consists of 18 items across five domains: relationship, goal, reflection, analysis and action, client response, and distinguishing. Each item is rated on a three-point Likert scale (1 = low and 3 = high). The percentage score can be calculated by dividing the total score by the possible maximum score. Higher percentage scores indicate higher fidelity, and the cut-off of sufficient fidelity of coaching per session is set at 80%.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 15, 2021
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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