The Effectiveness of a Parent-mediated Developmental Behavioral Intervention for Children With Autism Spectrum Disorder and Developmental Delay: A Randomized Controlled Trial
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
Long-distance learning program combined parent-mediated developmental behavioral intervention
Intervention: Long-distance developmental behavioral intervention (Behavioral)
Developmental behavioral intervention
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)