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Clinical Trials/NCT03812068
NCT03812068UnknownNot Applicable

The Effectiveness of a Parent-mediated Developmental Behavioral Intervention for Children With Autism Spectrum Disorder and Developmental Delay: A Randomized Controlled Trial

National Taiwan University Hospital2 sites in 1 country120 target enrollmentStarted: September 30, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
120
Locations
2
Primary Endpoint
Peabody Developmental Motor Scales, Second Edition

Study Overview

Brief Summary

This study explores the effectiveness of two intervention programs: "Long-distance developmental behavioral intervention" and "developmental behavioral interventions" for children with autism spectrum disorder or multiple developmental delays.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
30 Months to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Child's age between 30-84 months old.
  • Children have a diagnosis of autism spectrum disorder or multiple developmental delays.
  • Children without physical disabilities or major health problems, such as congenital limb defects.
  • One of the fathers or mothers involved in the study shall be the primary caregiver of the child.
  • The father or mother participating in the study has at least 9 education years and can read and understand Chinese.
  • The father or mother participating in the study is willing to allow the child to undergo a comprehensive development assessment and is willing to video during the training process.

Exclusion Criteria

  • Absence of chromosome abnormalities, congenital anomalies, and major neurological or sensory impairments or disorders (e.g., cerebral palsy, microcephalus, macrocephalus, severe brain damage, uncorrected vision, or hearing loss).

Arms & Interventions

Long-distance developmental behavioral intervention

Experimental

Long-distance learning program combined parent-mediated developmental behavioral intervention

Intervention: Long-distance developmental behavioral intervention (Behavioral)

Developmental behavioral intervention

Active Comparator

only parent-mediated developmental behavioral intervention

Intervention: Developmental behavioral intervention (Behavioral)

Outcomes

Primary Outcomes

Peabody Developmental Motor Scales, Second Edition

Time Frame: 3 months

measurement of multiple fine and gross motor functions

The Autism Diagnostic Observation Schedule

Time Frame: 3 months

measurement of autism status and severity level

Child Behavior Checklist Ages 1.5-5

Time Frame: 3 months

measurement of child's behavioral syndrome and problems

3D Gait Assessment Foot-worn Inertial Sensor

Time Frame: 3 months

measurement of gait performance

Pediatric Evaluation of Disability Inventory

Time Frame: 3 months

measurement of child's daily living function

Movement Assessment Battery for Children

Time Frame: 3 months

measurement of child's motor coordination

Mullen Scale of Early Learning

Time Frame: 3 months

measurement of child's cognitive and motor development

Secondary Outcomes

  • Parenting Sense of Competence Scale(3 months)
  • Parenting Stress Index(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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