Parent-mediated Developmental Behavioral Intervention (PDBI)

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

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 Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Long-distance developmental behavioral intervention; Behavioral: Developmental behavioral intervention

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yen-Tzu Wu, PhD; Phone Number: 886-2-33668136; Email: yenwu@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • School and Graduate Institute of Physical Therapy, National Taiwan University
    • Contact: Yen-Tzu Wu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: ASD; Development; Early intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 201809001RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No