NCT03812068

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

January 22, 2019

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

January 17, 2019

Last Update Submit

January 18, 2019

Conditions

Autism Spectrum Disorder

Keywords

ASDEarly interventionDevelopment

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (2)

  • Parenting Stress Index

    3 months

  • Parenting Sense of Competence Scale

    3 months

Study Arms (2)

Long-distance developmental behavioral intervention

EXPERIMENTAL

Long-distance learning program combined parent-mediated developmental behavioral intervention

Behavioral: Long-distance developmental behavioral intervention

Developmental behavioral intervention

ACTIVE COMPARATOR

only parent-mediated developmental behavioral intervention

Behavioral: Developmental behavioral intervention

Interventions

Long-distance developmental behavioral interventionBEHAVIORAL

Long-distance learning program combined parent-mediated developmental behavioral intervention

Long-distance developmental behavioral intervention
Developmental behavioral interventionBEHAVIORAL

Parent-mediated developmental behavioral intervention

Developmental behavioral intervention

Eligibility Criteria

Age30 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Yen-Tzu Wu, PhD

CONTACT

886-2-33668136yenwu@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 22, 2019

Study Start

September 30, 2018

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

January 22, 2019

Record last verified: 2018-10

Locations

TW(1)