Back to resultsParent-mediated Developmental Behavioral Intervention (PDBI)
Primary Purpose
Autism Spectrum Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Long-distance developmental behavioral intervention
Developmental behavioral intervention
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring ASD, Early intervention, Development
Eligibility Criteria
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).
Sites / Locations
- School and Graduate Institute of Physical Therapy, National Taiwan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Long-distance developmental behavioral intervention
Developmental behavioral intervention
Arm Description
Long-distance learning program combined parent-mediated developmental behavioral intervention
only parent-mediated developmental behavioral intervention
Outcomes
Primary Outcome Measures
The Autism Diagnostic Observation Schedule
measurement of autism status and severity level
Child Behavior Checklist Ages 1.5-5
measurement of child's behavioral syndrome and problems
Pediatric Evaluation of Disability Inventory
measurement of child's daily living function
Mullen Scale of Early Learning
measurement of child's cognitive and motor development
Movement Assessment Battery for Children
measurement of child's motor coordination
3D Gait Assessment Foot-worn Inertial Sensor
measurement of gait performance
Peabody Developmental Motor Scales, Second Edition
measurement of multiple fine and gross motor functions
Secondary Outcome Measures
Parenting Stress Index
measurement of parenting stress for parents
Parenting Sense of Competence Scale
measurement of the parent's self-efficacy and satisfaction as being parents
Full Information
NCT ID
NCT03812068
First Posted
January 17, 2019
Last Updated
January 18, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03812068
Brief Title
Parent-mediated Developmental Behavioral Intervention
Acronym
PDBI
Official Title
The Effectiveness of a Parent-mediated Developmental Behavioral Intervention for Children With Autism Spectrum Disorder and Developmental Delay: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
ASD, Early intervention, Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Long-distance developmental behavioral intervention
Arm Type
Experimental
Arm Description
Long-distance learning program combined parent-mediated developmental behavioral intervention
Arm Title
Developmental behavioral intervention
Arm Type
Active Comparator
Arm Description
only parent-mediated developmental behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Long-distance developmental behavioral intervention
Intervention Description
Long-distance learning program combined parent-mediated developmental behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Developmental behavioral intervention
Intervention Description
Parent-mediated developmental behavioral intervention
Primary Outcome Measure Information:
Title
The Autism Diagnostic Observation Schedule
Description
measurement of autism status and severity level
Time Frame
3 months
Title
Child Behavior Checklist Ages 1.5-5
Description
measurement of child's behavioral syndrome and problems
Time Frame
3 months
Title
Pediatric Evaluation of Disability Inventory
Description
measurement of child's daily living function
Time Frame
3 months
Title
Mullen Scale of Early Learning
Description
measurement of child's cognitive and motor development
Time Frame
3 months
Title
Movement Assessment Battery for Children
Description
measurement of child's motor coordination
Time Frame
3 months
Title
3D Gait Assessment Foot-worn Inertial Sensor
Description
measurement of gait performance
Time Frame
3 months
Title
Peabody Developmental Motor Scales, Second Edition
Description
measurement of multiple fine and gross motor functions
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Parenting Stress Index
Description
measurement of parenting stress for parents
Time Frame
3 months
Title
Parenting Sense of Competence Scale
Description
measurement of the parent's self-efficacy and satisfaction as being parents
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yen-Tzu Wu, PhD
Phone
886-2-33668136
Email
yenwu@ntu.edu.tw
Facility Information:
Facility Name
School and Graduate Institute of Physical Therapy, National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen-Tzu Wu, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Parent-mediated Developmental Behavioral Intervention
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