A Randomized Clinical Trial for Toddlers With ASD



Status:Completed
Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:11/22/2018
Start Date:September 2009
End Date:February 2013

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

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.


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)

Exclusion Criteria:

- Head injury prior to enrollment in the study

- Major hearing or visual impairment after correction

- Non-febrile seizures

- PKU (Phenylketonuria)

- Congenital Rubella (German measles)

- Neurofibromatosis

- Tuberous Sclerosis

- Fragile X

- A fall resulting in a loss of consciousness or other severe head injury

- Velo-Cardio Facial Syndrome

- Any other known genetic syndrome

- No foster children may participate

- The child must not be adopted
We found this trial at
1
site
707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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mi
from
Baltimore, MD
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