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Clinical Trials/NCT06079632
NCT06079632
Not Yet Recruiting
N/A

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

National Taiwan University Hospital0 sites68 target enrollmentOctober 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sensory Processing Disorder
Sponsor
National Taiwan University Hospital
Enrollment
68
Primary Endpoint
The child's social communication ability
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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, 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.

Registry
clinicaltrials.gov
Start Date
October 2023
End Date
July 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The child's social communication ability

Time Frame: 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. The score could range from 0 to 38, with higher scores implied greater social communication ability.

The performance and satisfaction with the child's daily participation

Time Frame: up to 25 weeks

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.

The parent's parent-child interaction strategy utilization

Time Frame: 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 score could range from 20 to 80, with higher scores implied greater parent-child interaction strategy utilization.

Secondary Outcomes

  • The social functioning and adaptive behavior of the child(up to 25 weeks)
  • The child's performance in social communication(up to 25 weeks)
  • The parent's self-perceived parental competence(through study completion, an average of 4 months)
  • The parent's self-perceived life quality within the last two weeks(up to 25 weeks)
  • The child's social communication ability(up to 25 weeks)
  • The attainment of the selected goal related to issues with the child's sensory processing disorder(through study completion, an average of 4 months)
  • The parent's self-perceived stress within the family system(up to 25 weeks)
  • The parent's parent-child interaction strategy utilization(up to 25 weeks)
  • The performance and satisfaction with the child's daily participation(through study completion, an average of 4 months)

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