Parent-mediated Developmental Behavioral Intervention

Autism Spectrum Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03812068
• Other study ID #: 201809001RINC
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2018
• Source: National Taiwan University Hospital
• Contact: Yen-Tzu Wu, PhD
• Phone: 886-2-33668136
• Email: yenwu[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Months and older

Eligibility

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).

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• Long-distance developmental behavioral intervention
Long-distance learning program combined parent-mediated developmental behavioral intervention
• Developmental behavioral intervention
Parent-mediated developmental behavioral intervention

Locations

Country	Name	City	State
Taiwan	School and Graduate Institute of Physical Therapy, National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Autism Diagnostic Observation Schedule	measurement of autism status and severity level	3 months
Primary	Child Behavior Checklist Ages 1.5-5	measurement of child's behavioral syndrome and problems	3 months
Primary	Pediatric Evaluation of Disability Inventory	measurement of child's daily living function	3 months
Primary	Mullen Scale of Early Learning	measurement of child's cognitive and motor development	3 months
Primary	Movement Assessment Battery for Children	measurement of child's motor coordination	3 months
Primary	3D Gait Assessment Foot-worn Inertial Sensor	measurement of gait performance	3 months
Primary	Peabody Developmental Motor Scales, Second Edition	measurement of multiple fine and gross motor functions	3 months
Secondary	Parenting Stress Index	measurement of parenting stress for parents	3 months
Secondary	Parenting Sense of Competence Scale	measurement of the parent's self-efficacy and satisfaction as being parents	3 months