A Randomized Clinical Trial for Toddlers With ASD

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT01008800

Run by

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

People needed

196

Starts

2009-09-01

Expected to finish

2013-02-01

Last updated by the study team

2021-03-10

Who can join

Age: 2 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Kennedy Krieger Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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