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

NCT ID: NCT06079632

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-07-31

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.

Conditions

Sensory Processing Disorder; Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

parent coaching via telehealth

Intervention Type: BEHAVIORAL

Participants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention.

RCT, Treatment group

Participant receive 12 weeks of sensory processing strategy coaching and parent-child interaction strategy coaching intervention.

Group Type: EXPERIMENTAL

parent coaching via telehealth

Intervention Type: BEHAVIORAL

Participants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention.

RCT, Active Comparator

Participant will be provided with weekly self-learning materials and group discussion session for 12 weeks.

Group Type: ACTIVE_COMPARATOR

weekly self-learning materials and group discussion session

Intervention Type: BEHAVIORAL

Participants receive 1-hour self-learning materials, including parent-child interaction and sensory processing strategies, and 1-hour remote group discussion session weekly.

Interventions

parent coaching via telehealth

Participants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council

FED

Sponsor Role: collaborator

National Taiwan University

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mei-Hui Tseng, phD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Central Contacts

Mei-Hui Tseng, phD

Role: CONTACT

mhtseng@ntu.edu.tw

886 2-3366-8175

Other Identifiers

202301189RINA

Identifier Type: -

Identifier Source: org_study_id