Developmental Disability
Conditions
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.
Interventions
BEHAVIORALOccupational 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.
BEHAVIORALParent 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.
Sponsors
Food and Health Bureau, Hong Kong
University of Otago
National Cheng Kung University
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Months to 83 Months
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participation-related Goal Performance and Satisfaction | 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. |
| Change in Children's Community Participation Frequency and Involvement | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Parenting Efficacy and Satisfaction | 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. |
| Change in Parents' Negative Emotional States | 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. |
| Change in Children's Psychosocial Health | 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
| Measure | Time frame | Description |
|---|---|---|
| Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | T2=1-2 weeks after intervention | The item score (1-7) of the Patient Global Impression of Change. Higher scores mean a worse outcome. |
| Retention Rate of Participants Who Complete the Trial | T3=8-9 weeks after the intervention | The percentage of participants who complete the trial (i.e., all assessments) |
| Number of Participants Recruited | T0=5-6 weeks before intervention | The percentage of eligible families agreeing to participate in the study |
| Blinding Success | T2=1-2 weeks after intervention | The percentage of parents who guess treatment allocation correctly after the study |
| Fidelity of Coaches Who Conduct the Occupational Performance Coaching | 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%. |
| Adherence Rate of Participants Who Attend the Coaching Sessions | T2=1-2 weeks after intervention | The percentage of coaching sessions attended by parents who are randomized to the intervention group |
| Stability in Children's Daily Activity and Social/Cognitive Function | 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. |
| Stability in Perceived Impact of Environmental Support on Children's Community Participation | 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. |
| Level of Therapeutic Alliance During Coaching Session | 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. |
| Level of Perceptions of Health Care Practitioners' Autonomy Support | 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. |
Countries
Hong Kong
Participant flow
Recruitment details
Young children with DD were recruited from preschool-rehabilitation services offered by three non-governmental organisations. Two-hundred-and-thirty-six invitations were distributed to interested parents, 61 who were interested for research participation and were then screened, and 50 whose children met the eligible criteria participated in the RCT.
Pre-assignment details
Out of the 61 parents who underwent eligibility screening, five did not meet inclusion criteria and six declined to participate. The 50 parents and their children (i,e., 50 dyads) were finally enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Parent Coaching Parents received OPC | 50 |
| Parent Consultation Parents received consultation | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Parent Coaching | Parent Consultation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous Children | 4.85 years STANDARD_DEVIATION 1 | 4.82 years STANDARD_DEVIATION 0.96 | 4.83 years STANDARD_DEVIATION 1 |
| Age, Continuous Parents | 35.92 years STANDARD_DEVIATION 5.99 | 39.44 years STANDARD_DEVIATION 3.72 | 37.68 years STANDARD_DEVIATION 5.25 |
| Community participation frequency for children | 3.02 units on a scale STANDARD_DEVIATION 0.79 | 2.74 units on a scale STANDARD_DEVIATION 0.9 | 2.88 units on a scale STANDARD_DEVIATION 0.85 |
| Community participation involvement for children | 3.85 units on a scale STANDARD_DEVIATION 0.77 | 3.77 units on a scale STANDARD_DEVIATION 0.72 | 3.81 units on a scale STANDARD_DEVIATION 0.74 |
| Community-related goal performance for children | 3.67 units on a scale STANDARD_DEVIATION 1.66 | 3.72 units on a scale STANDARD_DEVIATION 1.39 | 3.69 units on a scale STANDARD_DEVIATION 1.52 |
| Community-related goal satisfaction for parents | 3.90 units on a scale STANDARD_DEVIATION 1.62 | 3.57 units on a scale STANDARD_DEVIATION 1.45 | 3.73 units on a scale STANDARD_DEVIATION 1.53 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Hong Kong | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Children Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Children Male | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Parents Female | 24 Participants | 23 Participants | 47 Participants |
| Sex: Female, Male Parents Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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 (YC-PEM). Higher scores mean a better outcome.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Coaching | Change in Children's Community Participation Frequency and Involvement | Community frequency at T0 | 3.02 score on a scale | Standard Deviation 0.79 |
| Parent Coaching | Change in Children's Community Participation Frequency and Involvement | Community frequency at T1 | 3.14 score on a scale | Standard Deviation 0.83 |
| Parent Coaching | Change in Children's Community Participation Frequency and Involvement | Community frequency at T2 | 3.35 score on a scale | Standard Deviation 1 |
| Parent Coaching | Change in Children's Community Participation Frequency and Involvement | Community frequency at T3 | 3.42 score on a scale | Standard Deviation 1.18 |
| Parent Coaching | Change in Children's Community Participation Frequency and Involvement | Community involvement at T0 | 3.85 score on a scale | Standard Deviation 0.77 |
| Parent Coaching | Change in Children's Community Participation Frequency and Involvement | Community involvement at T1 | 3.77 score on a scale | Standard Deviation 0.69 |
| Parent Coaching | Change in Children's Community Participation Frequency and Involvement | Community involvement at T2 | 4.12 score on a scale | Standard Deviation 0.53 |
| Parent Coaching | Change in Children's Community Participation Frequency and Involvement | Community involvement at T3 | 4.08 score on a scale | Standard Deviation 0.64 |
| Parent Consultation | Change in Children's Community Participation Frequency and Involvement | Community involvement at T3 | 4.15 score on a scale | Standard Deviation 0.7 |
| Parent Consultation | Change in Children's Community Participation Frequency and Involvement | Community frequency at T0 | 2.74 score on a scale | Standard Deviation 0.9 |
| Parent Consultation | Change in Children's Community Participation Frequency and Involvement | Community involvement at T0 | 3.77 score on a scale | Standard Deviation 0.72 |
| Parent Consultation | Change in Children's Community Participation Frequency and Involvement | Community frequency at T1 | 2.79 score on a scale | Standard Deviation 1.12 |
| Parent Consultation | Change in Children's Community Participation Frequency and Involvement | Community involvement at T2 | 4.13 score on a scale | Standard Deviation 0.69 |
| Parent Consultation | Change in Children's Community Participation Frequency and Involvement | Community frequency at T2 | 2.81 score on a scale | Standard Deviation 1.06 |
| Parent Consultation | Change in Children's Community Participation Frequency and Involvement | Community involvement at T1 | 3.82 score on a scale | Standard Deviation 0.83 |
| Parent Consultation | Change in Children's Community Participation Frequency and Involvement | Community frequency at T3 | 2.91 score on a scale | Standard Deviation 0.95 |
p-value: 0.05Repeated-Measures ANCOVA
Primary
Change in Participation-related Goal Performance and Satisfaction
Performance and satisfaction scores (1-10) of the Canadian Occupational Performance Measure (COPM). Higher scores mean a better outcome.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Coaching | Change in Participation-related Goal Performance and Satisfaction | Performance at T0 | 3.67 score on a scale | Standard Deviation 1.66 |
| Parent Coaching | Change in Participation-related Goal Performance and Satisfaction | Performance at T1 | 4.92 score on a scale | Standard Deviation 1.73 |
| Parent Coaching | Change in Participation-related Goal Performance and Satisfaction | Performance at T2 | 7.29 score on a scale | Standard Deviation 1.49 |
| Parent Coaching | Change in Participation-related Goal Performance and Satisfaction | Performance at T3 | 7.16 score on a scale | Standard Deviation 1.3 |
| Parent Coaching | Change in Participation-related Goal Performance and Satisfaction | Satisfaction at T0 | 3.90 score on a scale | Standard Deviation 1.62 |
| Parent Coaching | Change in Participation-related Goal Performance and Satisfaction | Satisfaction at T1 | 4.85 score on a scale | Standard Deviation 1.87 |
| Parent Coaching | Change in Participation-related Goal Performance and Satisfaction | Satisfaction at T2 | 7.58 score on a scale | Standard Deviation 1.39 |
| Parent Coaching | Change in Participation-related Goal Performance and Satisfaction | Satisfaction at T3 | 7.32 score on a scale | Standard Deviation 1.33 |
| Parent Consultation | Change in Participation-related Goal Performance and Satisfaction | Satisfaction at T3 | 6.84 score on a scale | Standard Deviation 1.82 |
| Parent Consultation | Change in Participation-related Goal Performance and Satisfaction | Performance at T0 | 3.72 score on a scale | Standard Deviation 1.39 |
| Parent Consultation | Change in Participation-related Goal Performance and Satisfaction | Satisfaction at T0 | 3.57 score on a scale | Standard Deviation 1.45 |
| Parent Consultation | Change in Participation-related Goal Performance and Satisfaction | Performance at T1 | 4.69 score on a scale | Standard Deviation 1.7 |
| Parent Consultation | Change in Participation-related Goal Performance and Satisfaction | Satisfaction at T2 | 7.08 score on a scale | Standard Deviation 1.71 |
| Parent Consultation | Change in Participation-related Goal Performance and Satisfaction | Performance at T2 | 6.85 score on a scale | Standard Deviation 1.63 |
| Parent Consultation | Change in Participation-related Goal Performance and Satisfaction | Satisfaction at T1 | 4.68 score on a scale | Standard Deviation 1.84 |
| Parent Consultation | Change in Participation-related Goal Performance and Satisfaction | Performance at T3 | 6.84 score on a scale | Standard Deviation 1.68 |
p-value: 0.05Repeated-measures ANCOVA
Secondary
Change in Children's Psychosocial Health
Psychosocial health score (0-100) of the KINDL questionnaire. Higher scores mean a better outcome.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Coaching | Change in Children's Psychosocial Health | Psychological health at T0 | 67.50 score on a scale | Standard Deviation 10.52 |
| Parent Coaching | Change in Children's Psychosocial Health | Psychological health at T1 | 66.68 score on a scale | Standard Deviation 12.69 |
| Parent Coaching | Change in Children's Psychosocial Health | Psychological health at T2 | 70.00 score on a scale | Standard Deviation 12.52 |
| Parent Coaching | Change in Children's Psychosocial Health | Psychological health at T3 | 67.50 score on a scale | Standard Deviation 10.52 |
| Parent Consultation | Change in Children's Psychosocial Health | Psychological health at T3 | 65.50 score on a scale | Standard Deviation 11.84 |
| Parent Consultation | Change in Children's Psychosocial Health | Psychological health at T0 | 66.50 score on a scale | Standard Deviation 11.84 |
| Parent Consultation | Change in Children's Psychosocial Health | Psychological health at T2 | 67.81 score on a scale | Standard Deviation 10.33 |
| Parent Consultation | Change in Children's Psychosocial Health | Psychological health at T1 | 65.00 score on a scale | Standard Deviation 7.9 |
p-value: 0.05Repeated-Measures ANCOVA
Secondary
Change in Parenting Efficacy and Satisfaction
Efficacy scores (7-42) and satisfaction scores (9-56) of the Parenting Sense of Competence Scale (PSOC). Higher scores mean a better outcome.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Coaching | Change in Parenting Efficacy and Satisfaction | Parenting efficacy at T0 | 27.52 score on a scale | Standard Deviation 5.81 |
| Parent Coaching | Change in Parenting Efficacy and Satisfaction | Parenting efficacy at T1 | 27.76 score on a scale | Standard Deviation 6.06 |
| Parent Coaching | Change in Parenting Efficacy and Satisfaction | Parenting efficacy at T2 | 29.44 score on a scale | Standard Deviation 5.47 |
| Parent Coaching | Change in Parenting Efficacy and Satisfaction | Parenting efficacy at T3 | 28.76 score on a scale | Standard Deviation 5.78 |
| Parent Coaching | Change in Parenting Efficacy and Satisfaction | Parenting satisfaction at T0 | 31.60 score on a scale | Standard Deviation 7.37 |
| Parent Coaching | Change in Parenting Efficacy and Satisfaction | Parenting satisfaction at T1 | 30.72 score on a scale | Standard Deviation 8.38 |
| Parent Coaching | Change in Parenting Efficacy and Satisfaction | Parenting satisfaction at T2 | 33.80 score on a scale | Standard Deviation 6.67 |
| Parent Coaching | Change in Parenting Efficacy and Satisfaction | Parenting satisfaction at T3 | 31.76 score on a scale | Standard Deviation 8.08 |
| Parent Consultation | Change in Parenting Efficacy and Satisfaction | Parenting satisfaction at T3 | 33.32 score on a scale | Standard Deviation 8.07 |
| Parent Consultation | Change in Parenting Efficacy and Satisfaction | Parenting efficacy at T0 | 27.92 score on a scale | Standard Deviation 3.82 |
| Parent Consultation | Change in Parenting Efficacy and Satisfaction | Parenting satisfaction at T0 | 31.56 score on a scale | Standard Deviation 8.2 |
| Parent Consultation | Change in Parenting Efficacy and Satisfaction | Parenting efficacy at T1 | 27.52 score on a scale | Standard Deviation 4.54 |
| Parent Consultation | Change in Parenting Efficacy and Satisfaction | Parenting satisfaction at T2 | 33.16 score on a scale | Standard Deviation 7.8 |
| Parent Consultation | Change in Parenting Efficacy and Satisfaction | Parenting efficacy at T2 | 30.48 score on a scale | Standard Deviation 3.94 |
| Parent Consultation | Change in Parenting Efficacy and Satisfaction | Parenting satisfaction at T1 | 32.40 score on a scale | Standard Deviation 8.69 |
| Parent Consultation | Change in Parenting Efficacy and Satisfaction | Parenting efficacy at T3 | 29.28 score on a scale | Standard Deviation 4.87 |
p-value: 0.05Repeated-Measures ANCOVA
Secondary
Change in Parents' Negative Emotional States
The scores (0-42 for each subscale) of the Depression, Anxiety and Stress Scale-21 (DASS-21). Higher scores mean a worse outcome.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Coaching | Change in Parents' Negative Emotional States | Depression at T0 | 7.04 score on a scale | Standard Deviation 6.78 |
| Parent Coaching | Change in Parents' Negative Emotional States | Depression at T1 | 7.28 score on a scale | Standard Deviation 8.03 |
| Parent Coaching | Change in Parents' Negative Emotional States | Depression at T2 | 6.32 score on a scale | Standard Deviation 7.11 |
| Parent Coaching | Change in Parents' Negative Emotional States | Depression at T3 | 6.56 score on a scale | Standard Deviation 7.38 |
| Parent Coaching | Change in Parents' Negative Emotional States | Anxiety at Time 0 | 6.80 score on a scale | Standard Deviation 5.83 |
| Parent Coaching | Change in Parents' Negative Emotional States | Anxiety at T1 | 6.96 score on a scale | Standard Deviation 7.89 |
| Parent Coaching | Change in Parents' Negative Emotional States | Anxiety at T2 | 6.08 score on a scale | Standard Deviation 7.1 |
| Parent Coaching | Change in Parents' Negative Emotional States | Anxiety at T3 | 6.48 score on a scale | Standard Deviation 7.19 |
| Parent Coaching | Change in Parents' Negative Emotional States | Stress at T0 | 15.12 score on a scale | Standard Deviation 10.67 |
| Parent Coaching | Change in Parents' Negative Emotional States | Stress at T1 | 15.04 score on a scale | Standard Deviation 12.55 |
| Parent Coaching | Change in Parents' Negative Emotional States | Stress at T2 | 13.92 score on a scale | Standard Deviation 11.96 |
| Parent Coaching | Change in Parents' Negative Emotional States | Stress at T3 | 14.40 score on a scale | Standard Deviation 11.78 |
| Parent Consultation | Change in Parents' Negative Emotional States | Stress at T2 | 16.00 score on a scale | Standard Deviation 10.59 |
| Parent Consultation | Change in Parents' Negative Emotional States | Depression at T0 | 10.00 score on a scale | Standard Deviation 10.39 |
| Parent Consultation | Change in Parents' Negative Emotional States | Anxiety at T2 | 10.00 score on a scale | Standard Deviation 11.81 |
| Parent Consultation | Change in Parents' Negative Emotional States | Depression at T1 | 10.56 score on a scale | Standard Deviation 11.51 |
| Parent Consultation | Change in Parents' Negative Emotional States | Stress at T1 | 16.44 score on a scale | Standard Deviation 10.18 |
| Parent Consultation | Change in Parents' Negative Emotional States | Depression at T2 | 9.04 score on a scale | Standard Deviation 11.28 |
| Parent Consultation | Change in Parents' Negative Emotional States | Anxiety at T3 | 8.88 score on a scale | Standard Deviation 10 |
| Parent Consultation | Change in Parents' Negative Emotional States | Depression at T3 | 8.40 score on a scale | Standard Deviation 10.08 |
| Parent Consultation | Change in Parents' Negative Emotional States | Stress at T3 | 13.76 score on a scale | Standard Deviation 9.83 |
| Parent Consultation | Change in Parents' Negative Emotional States | Anxiety at Time 0 | 10.88 score on a scale | Standard Deviation 10.53 |
| Parent Consultation | Change in Parents' Negative Emotional States | Stress at T0 | 14.64 score on a scale | Standard Deviation 10.65 |
| Parent Consultation | Change in Parents' Negative Emotional States | Anxiety at T1 | 10.64 score on a scale | Standard Deviation 10.24 |
p-value: 0.05Repeated-Measures ANCOVA
Other Pre-specified
Adherence Rate of Participants Who Attend the Coaching Sessions
The percentage of coaching sessions attended by parents who are randomized to the intervention group
Time frame: T2=1-2 weeks after intervention
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Parent Coaching | Adherence Rate of Participants Who Attend the Coaching Sessions | 171 Number of sessions |
| Parent Consultation | Adherence Rate of Participants Who Attend the Coaching Sessions | 192 Number of sessions |
Other Pre-specified
Blinding Success
The percentage of parents who guess treatment allocation correctly after the study
Time frame: T2=1-2 weeks after intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parent Coaching | Blinding Success | 8 Participants |
| Parent Consultation | Blinding Success | 16 Participants |
Other Pre-specified
Fidelity of Coaches Who Conduct the Occupational Performance Coaching
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%.
Time frame: T2=1-2 weeks after intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parent Coaching | Fidelity of Coaches Who Conduct the Occupational Performance Coaching | 6 Participants |
Other Pre-specified
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.
Time frame: T2=1-2 weeks after intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parent Coaching | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | No change | 3 Participants |
| Parent Coaching | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | A little deterioration | 0 Participants |
| Parent Coaching | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | Much improved | 8 Participants |
| Parent Coaching | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | Much deterioration | 0 Participants |
| Parent Coaching | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | Very much improved | 3 Participants |
| Parent Coaching | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | Very much deterioration | 0 Participants |
| Parent Coaching | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | A little improved | 11 Participants |
| Parent Consultation | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | Very much deterioration | 0 Participants |
| Parent Consultation | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | A little improved | 12 Participants |
| Parent Consultation | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | Very much improved | 5 Participants |
| Parent Consultation | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | Much improved | 6 Participants |
| Parent Consultation | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | No change | 1 Participants |
| Parent Consultation | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | A little deterioration | 1 Participants |
| Parent Consultation | Level of Parents' Global Impression on the Improvement of Their Child's Community Participation | Much deterioration | 0 Participants |
p-value: 0.05Chi-squared
Other Pre-specified
Level of Perceptions of Health Care Practitioners' Autonomy Support
Total scores (1-7) of the Health Care Climate Questionnaire (HCCQ). Higher scores mean a better outcome.
Time frame: T1=1-2 weeks before intervention; T2=1-2 weeks after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Coaching | Level of Perceptions of Health Care Practitioners' Autonomy Support | T1 | 5.58 score on a scale | Standard Deviation 0.94 |
| Parent Coaching | Level of Perceptions of Health Care Practitioners' Autonomy Support | T2 | 5.72 score on a scale | Standard Deviation 0.9 |
| Parent Consultation | Level of Perceptions of Health Care Practitioners' Autonomy Support | T1 | 5.62 score on a scale | Standard Deviation 0.93 |
| Parent Consultation | Level of Perceptions of Health Care Practitioners' Autonomy Support | T2 | 6.12 score on a scale | Standard Deviation 0.85 |
p-value: 0.05t-test, 2 sided
Other Pre-specified
Level of Therapeutic Alliance During Coaching Session
Total scores (0-40) of the Session Rating Scale (SRS). Higher average scores mean a better outcome.
Time frame: Immediate after each of the coaching sessions during the intervention period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent Coaching | Level of Therapeutic Alliance During Coaching Session | 35.28 score on a scale | Standard Deviation 4.63 |
| Parent Consultation | Level of Therapeutic Alliance During Coaching Session | 36.53 score on a scale | Standard Deviation 4.09 |
p-value: 0.05t-test, 2 sided
Other Pre-specified
Number of Participants Recruited
The percentage of eligible families agreeing to participate in the study
Time frame: T0=5-6 weeks before intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parent Coaching | Number of Participants Recruited | 50 Participants |
Other Pre-specified
Retention Rate of Participants Who Complete the Trial
The percentage of participants who complete the trial (i.e., all assessments)
Time frame: T3=8-9 weeks after the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parent Coaching | Retention Rate of Participants Who Complete the Trial | 24 Participants |
| Parent Consultation | Retention Rate of Participants Who Complete the Trial | 25 Participants |
Other Pre-specified
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 (PEDI-CAT). Higher scores mean a better outcome.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Coaching | Stability in Children's Daily Activity and Social/Cognitive Function | Daily activity at T0 | 57.12 score on a scale | Standard Deviation 4.77 |
| Parent Coaching | Stability in Children's Daily Activity and Social/Cognitive Function | Social/cognitive function at T0 | 64.96 score on a scale | Standard Deviation 3.06 |
| Parent Coaching | Stability in Children's Daily Activity and Social/Cognitive Function | Social/cognitive function at T1 | 64.84 score on a scale | Standard Deviation 3.54 |
| Parent Coaching | Stability in Children's Daily Activity and Social/Cognitive Function | Daily activity at T2 | 59.16 score on a scale | Standard Deviation 3.92 |
| Parent Coaching | Stability in Children's Daily Activity and Social/Cognitive Function | Social/cognitive function at T2 | 66.40 score on a scale | Standard Deviation 3.09 |
| Parent Coaching | Stability in Children's Daily Activity and Social/Cognitive Function | Daily activity at T1 | 57.52 score on a scale | Standard Deviation 4.81 |
| Parent Coaching | Stability in Children's Daily Activity and Social/Cognitive Function | Social/cognitive function at T3 | 66.56 score on a scale | Standard Deviation 3.72 |
| Parent Coaching | Stability in Children's Daily Activity and Social/Cognitive Function | Daily activity at T3 | 59.08 score on a scale | Standard Deviation 4.27 |
| Parent Consultation | Stability in Children's Daily Activity and Social/Cognitive Function | Social/cognitive function at T3 | 66.12 score on a scale | Standard Deviation 3 |
| Parent Consultation | Stability in Children's Daily Activity and Social/Cognitive Function | Daily activity at T0 | 56.40 score on a scale | Standard Deviation 2.98 |
| Parent Consultation | Stability in Children's Daily Activity and Social/Cognitive Function | Daily activity at T1 | 56.48 score on a scale | Standard Deviation 3.53 |
| Parent Consultation | Stability in Children's Daily Activity and Social/Cognitive Function | Daily activity at T2 | 58.04 score on a scale | Standard Deviation 3.44 |
| Parent Consultation | Stability in Children's Daily Activity and Social/Cognitive Function | Daily activity at T3 | 58.12 score on a scale | Standard Deviation 3.5 |
| Parent Consultation | Stability in Children's Daily Activity and Social/Cognitive Function | Social/cognitive function at T1 | 63.92 score on a scale | Standard Deviation 2.87 |
| Parent Consultation | Stability in Children's Daily Activity and Social/Cognitive Function | Social/cognitive function at T2 | 65.80 score on a scale | Standard Deviation 3.36 |
| Parent Consultation | Stability in Children's Daily Activity and Social/Cognitive Function | Social/cognitive function at T0 | 63.56 score on a scale | Standard Deviation 3.45 |
p-value: 0.05Repeated-Measures ANCOVA
Other Pre-specified
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.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Coaching | Stability in Perceived Impact of Environmental Support on Children's Community Participation | Environmental support at T2 | 85.07 score on a scale | Standard Deviation 11.49 |
| Parent Coaching | Stability in Perceived Impact of Environmental Support on Children's Community Participation | Environmental support at T0 | 84.07 score on a scale | Standard Deviation 9.62 |
| Parent Coaching | Stability in Perceived Impact of Environmental Support on Children's Community Participation | Environmental support at T3 | 84.86 score on a scale | Standard Deviation 8.72 |
| Parent Coaching | Stability in Perceived Impact of Environmental Support on Children's Community Participation | Environmental support at T1 | 83.84 score on a scale | Standard Deviation 11.65 |
| Parent Consultation | Stability in Perceived Impact of Environmental Support on Children's Community Participation | Environmental support at T3 | 80.31 score on a scale | Standard Deviation 11.73 |
| Parent Consultation | Stability in Perceived Impact of Environmental Support on Children's Community Participation | Environmental support at T1 | 80.70 score on a scale | Standard Deviation 10.4 |
| Parent Consultation | Stability in Perceived Impact of Environmental Support on Children's Community Participation | Environmental support at T2 | 83.29 score on a scale | Standard Deviation 11.35 |
| Parent Consultation | Stability in Perceived Impact of Environmental Support on Children's Community Participation | Environmental support at T0 | 78.11 score on a scale | Standard Deviation 11.35 |
p-value: 0.05Repeated-Measures ANCOVA