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

NCT05810675 | Unknown DMC

• 1 other identifier: 202207134RINB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

autism spectrum disorder, telehealth, holistic health care

Outcome Measures

Primary Outcomes (3)

• 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.

  16 weeks

• 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

  16 weeks

• 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.

  16 weeks

Secondary Outcomes (2)

• Parenting Stress Index (PSI)

  16 weeks

• Satisfaction Questionnaire

  16 weeks

Study Arms (2)

Telehealth Early Intervention Program (TEIP) group

EXPERIMENTAL

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.

Behavioral: Telehealth Early Intervention Program (TEIP)

Telephone group

NO INTERVENTION

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

Interventions

Telehealth Early Intervention Program (TEIP) BEHAVIORAL

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.

Also known as: TEIP

Telehealth Early Intervention Program (TEIP) group

Eligibility Criteria

• Age: 24 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with major sensory, motor or neurological impairment/disorder (e.g., uncorrected visual or hearing loss, or severe brain damage)

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital Hsin-Chu Branch: collaborator

Study Sites (1)

School and Graduate Institute of Physical Therapy

Taipei, 10055, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded for the group of participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 12, 2023
• Study Start: August 19, 2022
• Primary Completion: August 18, 2024
• Study Completion: August 18, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)