Telehealth Parent Coaching to Improve Activity Participation for Young Children With ASD and SPD

Study Overview
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Brief Summary
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This clinical trial aims to develop parent-child interaction strategy coaching and sensory processing strategy coaching via Telehealth and examine the feasibility and efficacy of the interventions in young children with autism spectrum disorder who have sensory processing disorder. In the first experiment, the investigators will apply a single-subject research design and one-group pre-post test design to explore the feasibility of the coaching interventions. In the second experiment, RCT design will be used to examine the effectiveness of parent coaching. Sixty-five children with ASD and their parents will be randomly assigned to the intervention or control group. The intervention group will receive weekly parent-child interaction and sensory processing strategy coaching for 12 weeks. The control group will be provided with weekly self-learning materials and group discussion session for 12 weeks. Additionally, the follow-up test will be administered three months after the intervention.

Official Title
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Telehealth Parent Coaching to Improve Activity Participation for Young Children With Autism Spectrum Disorder and Sensory Processing Disorders: A Prospective Study

Conditions
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Sensory Processing Disorder, Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: parent coaching via telehealth
* Behavioral: weekly self-learning materials and group discussion session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The child is 3 to 5 years old The child is diagnosed with ASD by a child psychiatrist or specialist in psychology based on the DSM-5's diagnostic criteria The child's score falls within the category of dysfunction in one or more sensory processing functions in the Sensory Profile (3-10 years old version) Exclusion Criteria: Children diagnosed with major neuromuscular dysfunction or other disease diagnoses, such as epilepsy or other genetic diseases Children whose parents could not speak Hokkenese or Chinese and read in Chinese Individuals who have participated in the first year of this study

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In the first experiment, multiple baseline design will be used to examine the feasibility of the interventions. Each participant will first receive parent-child interaction strategy coaching every week via Telehealth, followed by sensory processing strategy coaching (C1) provided every week via Telehealth. In the second experiment, RCT design will be applied to explore the efficacy of the interventions. Participants will be randomly allocated to the treatment group or the control group. The intervention group will receive weekly, one-on-one parent-child interaction and sensory processing strategy coaching via Telehealth for 12 weeks. The control group will be provided with weekly self-learning materials and group discussion session for 12 weeks. Measures will be taken at pre-test, post-test, and 3-month follow-up.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single subject experiment<br>Each participant will first receive one-hour, one-on-one parent-child interaction strategy coaching every week via Telehealth until the parent's parent-child interaction skills and the child's social communication abilities reach a stable or upward trend, and the parent's sensory processing strategy utilization ability and the child's daily life participation scores that are continuously collected shows a stable or downward trend. After which, the one-hour, one-on-one sensory processing strategy coaching (C1) will be provided every week via Telehealth until the parent's sensory processing strategy utilization ability and the child's activity participation level reaches a stable trend. | Behavioral: parent coaching via telehealth<br>* Participants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention.<br>|
| Experimental: RCT, Treatment group<br>Participant receive 12 weeks of sensory processing strategy coaching and parent-child interaction strategy coaching intervention. | Behavioral: parent coaching via telehealth<br>* Participants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention.<br>|
| Active Comparator: RCT, Active Comparator<br>Participant will be provided with weekly self-learning materials and group discussion session for 12 weeks. | Behavioral: weekly self-learning materials and group discussion session<br>* Participants receive 1-hour self-learning materials, including parent-child interaction and sensory processing strategies, and 1-hour remote group discussion session weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The performance and satisfaction with the child's daily participation | Measured by the Canadian Occupational Performance Measure in the RCT experiment. The score could range from 1 to 10, with higher scores implied greater performance and higher satisfaction with the child's daily participation. | up to 25 weeks | 
| The parent's parent-child interaction strategy utilization | Measured by the self-developed measurement - the Parental Parent-Child Interaction Strategy Rating Scale in the single subject experiment. The score could range from 20 to 80, with higher scores implied greater parent-child interaction strategy utilization. | through study completion, an average of 4 months | 
| The child's social communication ability | Measured by the self-developed measurement - the Social Communication Rating Scale for young children in the single subject experiment. The score could range from 0 to 38, with higher scores implied greater social communication ability. | through study completion, an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The social functioning and adaptive behavior of the child | Measured by the Vineland Adaptive Behavior Scales - Third Edition in the RCT experiment. The score could range from 20 to 160, with higher scores implied greater social functioning and adaptive behavior. | up to 25 weeks | 
| The attainment of the selected goal related to issues with the child's sensory processing disorder | Measured by the Goal Attainment Scale in the RCT experiment. The score could range from -2 to 2, with higher scores implied greater attainment of the selected goal related to issues with the child's sensory processing disorder. | up to 25 weeks | 
| The attainment of the selected goal related to issues with the child's sensory processing disorder | Measured by the Goal Attainment Scale in the single subject experiment. The score could range from -2 to 2, with higher scores implied greater attainment of the selected goal related to issues with the child's sensory processing disorder. | through study completion, an average of 4 months | 
| The child's performance in social communication | Measured by the Brief Observation of Social Communication Change in the RCT experiment. The score could range from 0 to 85, with higher scores implied greater social communication performance. | up to 25 weeks | 
| The parent's self-perceived parental competence | Measured by the Parenting Sense of Competence Scale in the RCT experiment. The score could range from 17 to 102, with higher scores implied greater self-perceived parental competence. | up to 25 weeks | 
| The parent's self-perceived parental competence | Measured by the Parenting Sense of Competence Scale in the single subject experiment. The score could range from 17 to 102, with higher scores implied greater self-perceived parental competence. | through study completion, an average of 4 months | 
| The parent's self-perceived stress within the family system | Measured by the Parenting Stress Index - Short Form in the RCT experiment. The score could range from 35 to 175, with higher scores implied greater self-perceived stress within the family system | up to 25 weeks | 
| The parent's self-perceived life quality within the last two weeks | Measured by the WHOQOL-BREF - Taiwan version in the RCT experiment. The score could range from 4 to 20 in each domain, with higher scores implied greater self-perceived life quality within the last two weeks | up to 25 weeks | 
| The child's social communication ability | Measured by the self-developed measurement - the Social Communication Rating Scale for young children in the RCT experiment. The score could range from 0 to 38, with higher scores implied greater social communication ability | up to 25 weeks | 
| The parent's parent-child interaction strategy utilization | Measured by the self-developed measurement - the Parental Parent-Child Interaction Strategy Rating Scale in the RCT experiment. The score could range from 20 to 80, with higher scores implied greater parent-child interaction strategy utilization. | up to 25 weeks | 
| The performance and satisfaction with the child's daily participation | Measured by the Canadian Occupational Performance Measure in the single subject experiment. The score could range from 1 to 10, with higher scores implied greater performance or higher satisfaction with the child's daily participation. | through study completion, an average of 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensory Processing Disorder, Parent-mediated intervention, Autism Spectrum Disorder, Parent Coaching via Telehealth