Parent-mediated vs Center-based Intervention for Toddlers With ASD: An RCT

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.1 site in 1 country196 target enrollmentSeptember 2009

ConditionsAutism Spectrum Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Autism Spectrum Disorder
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Enrollment: 196
Locations: 1
Primary Endpoint: Communication and Symbolic Behavior Scales
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This research is being done to test the effectiveness of two treatments aimed at increasing language and social skills in children with autism spectrum disorder. If children show improvement in these treatments, we hope that the availability of public services for minority and low income families will be increased. Minority and low income families with children between 22 and 33 months of age with Autism Spectrum Disorders may join.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

February 2013

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Responsible Party

Principal Investigator

Rebecca Landa

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Eligibility Criteria

Inclusion Criteria

•Participants must be 22 to 33 months old
•Children must meet criteria for ASD or autism on the ADOS plus receive a clinical judgment of PDD-NOS or autism by the study team
•Children must have an age equivalent of 8 months or greater for non-verbal ability based on the Mullen Visual Reception and Fine Motor scales
•Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
•The parent (or other primary caregiver, such as grandparent) in the Parent-Mediated condition must agree to attend the training sessions three times per month
•Parents must be between the ages of 16 and 50 years old
•Families who qualify for medical assistance and/or have racial/ethnic minority backgrounds will be prioritized for recruitment and participation in this study. On the TSI, we will ask participants if they qualify for medical assistance or if they are of a racial minority or have a first degree relative of a racial minority. Families who do not fit these criteria will be notified that they may be eligible to participate if additional space is available.
•It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home)