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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06079632

Collaborator

National Science and Technology Council (U.S. Fed), National Taiwan University (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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, we 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.

Condition or Disease	Intervention/Treatment	Phase
Sensory Processing Disorder Autism Spectrum Disorder	Behavioral: parent coaching via telehealth Behavioral: weekly self-learning materials and group discussion session	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Parent Coaching Via Telehealth on Activity Participation in Young Children With Autism Spectrum Disorder Who Have Sensory Processing Disorders: A Preliminary Study

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The performance and satisfaction with the child's daily participation [up to 25 weeks]
Measured by the Canadian Occupational Performance Measure in the RCT experiment
The parent's parent-child interaction strategy utilization [through study completion, an average of 4 months]
Measured by the self-developed measurement - the Parental Parent-Child Interaction Strategy Rating Scale in the single subject experiment.
The child's social communication ability [through study completion, an average of 4 months]
Measured by the self-developed measurement - the Social Communication Rating Scale for young children in the single subject experiment.

Secondary Outcome Measures

The social functioning and adaptive behavior of the child [up to 25 weeks]
Measured by the Vineland Adaptive Behavior Scales - Third Edition in the RCT experiment
The attainment of the selected goal related to issues with the child's sensory processing disorder [up to 25 weeks]
Measured by the Goal Attainment Scale in the RCT experiment
The attainment of the selected goal related to issues with the child's sensory processing disorder [through study completion, an average of 4 months]
Measured by the Goal Attainment Scale in the single subject experiment
The child's performance in social communication [up to 25 weeks]
Measured by the Brief Observation of Social Communication Change in the RCT experiment
The parent's self-perceived parental competence [up to 25 weeks]
Measured by the Parenting Sense of Competence Scale in the RCT experiment
The parent's self-perceived parental competence [through study completion, an average of 4 months]
Measured by the Parenting Sense of Competence Scale in the single subject experiment
The parent's self-perceived stress within the family system [up to 25 weeks]
Measured by the Parenting Stress Index - Short Form in the RCT experiment
The parent's self-perceived life quality within the last two weeks [up to 25 weeks]
Measured by the WHOQOL-BREF - Taiwan version in the RCT experiment
The child's social communication ability [up to 25 weeks]
Measured by the self-developed measurement - the Social Communication Rating Scale for young children in the RCT experiment
The parent's parent-child interaction strategy utilization [up to 25 weeks]
Measured by the self-developed measurement - the Parental Parent-Child Interaction Strategy Rating Scale in the RCT experiment
The performance and satisfaction with the child's daily participation [through study completion, an average of 4 months]
Measured by the Canadian Occupational Performance Measure in the single subject experiment

Other Outcome Measures

The parent's satisfaction with the online intervention [1 week]
Measured by self-developed questionnaire used to assess parental parent's satisfaction with the online intervention in the RCT experiment
The parent's satisfaction with the online intervention [1 week]
Measured by self-developed questionnaire used to assess parental parent's satisfaction with the online intervention in the single subject experiment
The coach's satisfaction with the online intervention [1 week]
Measured by self-developed questionnaire used to assess the coach's satisfaction with the online intervention in the RCT experiment
The coach's satisfaction with the online intervention [1 week]
Measured by self-developed questionnaire used to assess the coach's satisfaction with the online intervention in the single subject experiment

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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