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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder; Sensory Processing Disorder
• Intervention / Treatment: Behavioral: parent coaching via telehealth; Behavioral: weekly self-learning materials and group discussion session

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mei-Hui Tseng, phD; Phone Number: 886 2-3366-8175; Email: mhtseng@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single subject experiment; 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; Participants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention.
Experimental: RCT, Treatment group; Participant receive 12 weeks of sensory processing strategy coaching and parent-child interaction strategy coaching intervention.	Behavioral: parent coaching via telehealth; Participants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention.
Active Comparator: RCT, Active Comparator; 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; Participants receive 1-hour self-learning materials, including parent-child interaction and sensory processing strategies, and 1-hour remote group discussion session weekly.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The parent's satisfaction with the online intervention	Measured by self-developed questionnaire used to assess parental parent's satisfaction with the online intervention in the RCT experiment. The score could range from 17 to 68, with higher scores implied higher satisfaction with the online intervention.	1 week
The parent's satisfaction with the online intervention	Measured by self-developed questionnaire used to assess parental parent's satisfaction with the online intervention in the single subject experiment. The score could range from 17 to 68, with higher scores implied higher satisfaction with the online intervention.	1 week
The coach's satisfaction with the online intervention	Measured by self-developed questionnaire used to assess the coach's satisfaction with the online intervention in the RCT experiment. The score could range from 11 to 44, with higher scores implied higher satisfaction with the online intervention.	1 week
The coach's satisfaction with the online intervention	Measured by self-developed questionnaire used to assess the coach's satisfaction with the online intervention in the single subject experiment. The score could range from 11 to 44, with higher scores implied higher satisfaction with the online intervention.	1 week

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Taiwan University; National Science and Technology Council
• Investigators: Principal Investigator: Mei-Hui Tseng, phD, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Autism Spectrum Disorder; Parent-mediated intervention; Sensory Processing Disorder; Parent Coaching via Telehealth
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 202301189RINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No