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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079632
• Other study ID #: 202301189RINA
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: July 2025

Study information

• Verified date: September 2023
• Source: National Taiwan University Hospital
• Contact: Mei-Hui Tseng, phD
• Phone: 886 2-3366-8175
• Email: mhtseng[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Sensory Processing Disorder

Intervention

Behavioral:
• parent coaching via telehealth
Participants receive 12 weeks of parent-child interaction strategy coaching and sensory processing strategy coaching intervention.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science and Technology Council, National Taiwan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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