Parent-mediated Developmental Behavioral Intervention

Study Overview
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Brief Summary
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Long-distance developmental behavioral intervention
* Behavioral: Developmental behavioral intervention


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 30 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long-distance developmental behavioral intervention<br>Long-distance learning program combined parent-mediated developmental behavioral intervention | Behavioral: Long-distance developmental behavioral intervention<br>* Long-distance learning program combined parent-mediated developmental behavioral intervention<br>|
| Active Comparator: Developmental behavioral intervention<br>only parent-mediated developmental behavioral intervention | Behavioral: Developmental behavioral intervention<br>* Parent-mediated developmental behavioral intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Autism Diagnostic Observation Schedule | measurement of autism status and severity level | 3 months | 
| Child Behavior Checklist Ages 1.5-5 | measurement of child's behavioral syndrome and problems | 3 months | 
| Pediatric Evaluation of Disability Inventory | measurement of child's daily living function | 3 months | 
| Mullen Scale of Early Learning | measurement of child's cognitive and motor development | 3 months | 
| Movement Assessment Battery for Children | measurement of child's motor coordination | 3 months | 
| 3D Gait Assessment Foot-worn Inertial Sensor | measurement of gait performance | 3 months | 
| Peabody Developmental Motor Scales, Second Edition | measurement of multiple fine and gross motor functions | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting Stress Index | measurement of parenting stress for parents | 3 months | 
| Parenting Sense of Competence Scale | measurement of the parent's self-efficacy and satisfaction as being parents | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASD, Early intervention, Development