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

NCT06079632 | Unknown

• 1 other identifier: 202301189RINA
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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

Keywords

Sensory Processing Disorder; Parent-mediated intervention; Autism Spectrum Disorder; Parent Coaching via Telehealth

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• The social functioning and adaptive behavior of the child

  up to 25 weeks

• The 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

  through study completion, an average of 4 months

• The child's performance in social communication

  up to 25 weeks

• The parent's self-perceived parental competence

  up to 25 weeks

Other Outcomes (4)

• The parent's satisfaction with the online intervention

  1 week

• The parent's satisfaction with the online intervention

  1 week

• The coach's satisfaction with the online intervention

  1 week

Study Arms (3)

Single subject experiment

EXPERIMENTAL

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

RCT, Treatment group

EXPERIMENTAL

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

Behavioral: parent coaching via telehealth

RCT, Active Comparator

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

Interventions

parent coaching via telehealth BEHAVIORAL

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

RCT, Treatment group; Single subject experiment

weekly self-learning materials and group discussion session BEHAVIORAL

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

RCT, Active Comparator

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council: collaborator
• National Taiwan University: collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Mei-Hui Tseng, phD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Hui Tseng, phD

CONTACT

886 2-3366-8175; mhtseng@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 12, 2023
• Study Start: October 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-09