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Parent-mediated and Telehealth Intervention for Children With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Telehealth Early Intervention Program (TEIP)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism spectrum disorder, telehealth, holistic health care

Eligibility Criteria

24 Months - 72 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: child's age within 24-72 months parental age greater than 18 years parents have a minimum 9 years of education year that can read Chinese. Exclusion Criteria: Children with major sensory, motor or neurological impairment/disorder (e.g., uncorrected visual or hearing loss, or severe brain damage)

Sites / Locations

  • School and Graduate Institute of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telehealth Early Intervention Program (TEIP) group

Telephone group

Arm Description

The TEIP group will also receive a 16-week telehealth intervention with guidance, digital learning platform, teaching parents to learn intervention skills to improve children's attention and play ability, social communication, cognition, perceptual movement, and improve parents' management of children's behavior problems.

The telephone group will receive 16-weeks of care and child development counseling through phone calls.

Outcomes

Primary Outcome Measures

Mullen Scale of Early Learning (MSEL)
The MSEL assesses the child's developmental skills that provides standardized scores in five domains: Visual Reception, Receptive Language, Expressive Language, Fine Motor skills, and Gross Motor skills. The MSEL scores will be processed to examine the changes between the baseline and the post training.
Peabody Developmental Motor Scales, Second Edition (PDMS2)
The PDMS-2 is a norm-referenced assessment comprising 6 subscales, namely Reflexes, Locomotion, Object. The PDMS-2 scores will be processed to examine the changes between the baseline and the post training. Manipulation, Stationary, Grasping, and Visual-Motor Integration
Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)
The CBCL/1.5-5, a parental report of child behavioral, emotional and social functioning at ages 1.5-5 years, consists of 100 items. The CBCL/1.5-5 scores will be processed to examine the changes between the baseline and the post training.

Secondary Outcome Measures

Parenting Stress Index (PSI)
The PSI is a 120-item, 5-point parent-report measure assessing parenting stress factors. The PSI scores will be processed to examine the changes between the baseline and the post training.
Satisfaction Questionnaire
Participating parents will be asked to complete a questionnaire assessing their satisfaction with the training that is specifically created for the purpose of the proposed study. The satisfaction questionnaire will only be filled out by participating parents at the time when complete all intervention.

Full Information

First Posted
March 20, 2023
Last Updated
March 31, 2023
Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital Hsin-Chu Branch
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1. Study Identification

Unique Protocol Identification Number
NCT05810675
Brief Title
Parent-mediated and Telehealth Intervention for Children With Autism Spectrum Disorder
Official Title
Parent-mediated and Telehealth Intervention for Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
August 18, 2024 (Anticipated)
Study Completion Date
August 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital Hsin-Chu Branch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study has two purposes: Aim 1: To develop a Telehealth Early Intervention Program (TEIP) for children with ASD that will be carried out by parents at home when interact with their children; and to train parents in delivering developmental and behavioral techniques to their children. The participating families will be randomized in parallel to treatment and comparison groups for teaching the knowledge and techniques: (1) Treatment group: providing the training of TEIP for parents via telehealth modalities as they learn critical skills with their child with the goal of increasing multidimensional child developments. Intervention provider will provide the training for parent-child dyad interaction to work with parents to implement these strategies at home environment; and (2) Comparison group: provide general care consultation of child development for parents. Aim 2: To evaluate this program's effectiveness by measuring changes in a child's developments and behaviors. Investigator will evaluate child outcomes on the symptoms of ASD and multidimensional developmental functioning. Furthermore, investigator will measure the changes in the parent's knowledge and behaviors of parent-child interaction. Moreover, investigator will determine if parental participation in the intervention is associated with an improvement in parenting competences and decreased levels of stress.
Detailed Description
In recent years, due to the rapid increase in the prevalence of autism spectrum disorder (ASD), early detection of these children is helpful for early diagnosis and intervention and better prognosis. Recent research supports the intervention in the daily life of children with autism in a naturalized way. Parents learn intervention skills and implement them in their lives, providing positive effects on children with autism. This type of intervention is called parent-mediated intervention. Pivot Response Training (PRT) is a home-based parent-child intervention model that uses "Applied Behavior Analysis" to integrate into children's daily life situations and teach children to respond appropriately to the many learning opportunities and social interactions in natural situations, reducing reliance on therapist supervision, and care services that hinder children from natural situations. However, there are many obstacles at present. In addition to insufficient resources, long waiting time for accessing services, and the COVID-19 Pandemic or future emerging infections interrupting in-person face-to-face services, remote guidance of parents to implement the intervention at home (telehealth) is another way to help children and families with developmental disabilities. This way of giving patients holistic health care is a new trend in providing early intervention services. Therefore, this study plans to first conduct team education and discussion, and then use our highly reliable screening tool to screen children aged 24-72 months for autism screening in the community and institutes. Those screened with a positive result will be referred to our early intervention center for comprehensive child development and behavioral follow-up. A total of 60 children over 24 months old diagnosed with ASD will participate in the telehealth intervention program. They will be randomly assigned to the intervention group or the comparison group. The intervention group (the telehealth group) will also receive a 16-week telehealth intervention with guidance, digital learning platform, teaching parents to learn intervention skills to improve children's attention and play ability, social communication, cognition, perceptual movement, and improve parents' management of children's behavior problems. The comparison group (telephone group) will receive 16-weeks of child development counseling through phone calls. This project aims to enhance the education and cooperation of the team, increase the awareness and understanding of ASD in the community, strengthen the use of relevant screening tools, provide an easy-accessed E-learning platform for parents, daycare or kindergarten caregivers or professionals to learn, and establish an evidence-based telehealth early intervention for autistic children. In this way, parents of autistic children would have more confidence and support to go for screening and intervention to achieve patient- and family-centered holistic care and enhance their compliance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism spectrum disorder, telehealth, holistic health care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention group (the telehealth group) will also receive a 16-week telehealth intervention with guidance, digital learning platform, teaching parents to learn intervention skills to improve children's attention and play ability, social communication, cognition, perceptual movement, and improve parents' management of children's behavior problems. The comparison group (telephone group) will receive 16-weeks of care and child development counseling through phone calls.
Masking
Outcomes Assessor
Masking Description
Outcome assessor will be blinded for the group of participants
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telehealth Early Intervention Program (TEIP) group
Arm Type
Experimental
Arm Description
The TEIP group will also receive a 16-week telehealth intervention with guidance, digital learning platform, teaching parents to learn intervention skills to improve children's attention and play ability, social communication, cognition, perceptual movement, and improve parents' management of children's behavior problems.
Arm Title
Telephone group
Arm Type
No Intervention
Arm Description
The telephone group will receive 16-weeks of care and child development counseling through phone calls.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Early Intervention Program (TEIP)
Other Intervention Name(s)
TEIP
Intervention Description
The Telehealth Early Intervention Program (TEIP) that will be carried out by parents at home when interact with their children; and to train parents in delivering developmental and behavioral techniques to their children. The participating families will be randomized in parallel to treatment and comparison groups for teaching the knowledge and techniques: (1) Treatment group: providing the training of TEIP for parents via telehealth modalities as they learn critical skills with their child with the goal of increasing multidimensional child developments. Intervention provider will provide the training for parent-child dyad interaction to work with parents to implement these strategies at home environment.
Primary Outcome Measure Information:
Title
Mullen Scale of Early Learning (MSEL)
Description
The MSEL assesses the child's developmental skills that provides standardized scores in five domains: Visual Reception, Receptive Language, Expressive Language, Fine Motor skills, and Gross Motor skills. The MSEL scores will be processed to examine the changes between the baseline and the post training.
Time Frame
16 weeks
Title
Peabody Developmental Motor Scales, Second Edition (PDMS2)
Description
The PDMS-2 is a norm-referenced assessment comprising 6 subscales, namely Reflexes, Locomotion, Object. The PDMS-2 scores will be processed to examine the changes between the baseline and the post training. Manipulation, Stationary, Grasping, and Visual-Motor Integration
Time Frame
16 weeks
Title
Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)
Description
The CBCL/1.5-5, a parental report of child behavioral, emotional and social functioning at ages 1.5-5 years, consists of 100 items. The CBCL/1.5-5 scores will be processed to examine the changes between the baseline and the post training.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Parenting Stress Index (PSI)
Description
The PSI is a 120-item, 5-point parent-report measure assessing parenting stress factors. The PSI scores will be processed to examine the changes between the baseline and the post training.
Time Frame
16 weeks
Title
Satisfaction Questionnaire
Description
Participating parents will be asked to complete a questionnaire assessing their satisfaction with the training that is specifically created for the purpose of the proposed study. The satisfaction questionnaire will only be filled out by participating parents at the time when complete all intervention.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: child's age within 24-72 months parental age greater than 18 years parents have a minimum 9 years of education year that can read Chinese. Exclusion Criteria: Children with major sensory, motor or neurological impairment/disorder (e.g., uncorrected visual or hearing loss, or severe brain damage)
Facility Information:
Facility Name
School and Graduate Institute of Physical Therapy
City
Taipei
ZIP/Postal Code
10055
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen-Tzu Wu, PhD
Phone
886-963663269
Email
yenwu@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Parent-mediated and Telehealth Intervention for Children With Autism Spectrum Disorder

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