Clinical trial NCT06079632: Telehealth Parent Coaching to Improve Activity Participation for Young Children With ASD and SPD
Official title: Telehealth Parent Coaching to Improve Activity Participation for Young Children With Autism Spectrum Disorder and Sensory Processing Disorders: A Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sensory Processing Disorder
Autism Spectrum Disorder
Keywords: Sensory Processing Disorder
Parent-mediated intervention
Autism Spectrum Disorder
Parent Coaching via Telehealth
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
name: National Taiwan University
First posted: 2023-10-12
Enrollment: 68
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The performance and satisfaction with the child's daily participation
timeFrame: up to 25 weeks
measure: The parent's parent-child interaction strategy utilization
timeFrame: through study completion, an average of 4 months
measure: The child's social communication ability
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
measure: The social functioning and adaptive behavior of the child
timeFrame: up to 25 weeks
measure: The attainment of the selected goal related to issues with the child's sensory processing disorder
timeFrame: up to 25 weeks
measure: The attainment of the selected goal related to issues with the child's sensory processing disorder
timeFrame: through study completion, an average of 4 months
measure: The child's performance in social communication
timeFrame: up to 25 weeks
measure: The parent's self-perceived parental competence
timeFrame: up to 25 weeks
measure: The parent's self-perceived parental competence
timeFrame: through study completion, an average of 4 months
measure: The parent's self-perceived stress within the family system
timeFrame: up to 25 weeks
measure: The parent's self-perceived life quality within the last two weeks
timeFrame: up to 25 weeks
measure: The child's social communication ability
timeFrame: up to 25 weeks
measure: The parent's parent-child interaction strategy utilization
timeFrame: up to 25 weeks
measure: The performance and satisfaction with the child's daily participation
timeFrame: through study completion, an average of 4 months
Other outcomes:
measure: The parent's satisfaction with the online intervention
timeFrame: 1 week
measure: The parent's satisfaction with the online intervention
timeFrame: 1 week
measure: The coach's satisfaction with the online intervention
timeFrame: 1 week
measure: The coach's satisfaction with the online intervention
timeFrame: 1 week
Locations:
Study officials:
affiliation: National Taiwan University
name: Mei-Hui Tseng, phD
role: PRINCIPAL_INVESTIGATOR
References: