A Randomized Clinical Trial for Toddlers With ASD

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

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Social communication; Behavioral: Social Communication

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01008800

R40 MC 15594-01

NA_00030329 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 22 to 33 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Center-Based classroom intervention

Experimental group

Description:

Four days a week for 2.5 hours a day the child will participate in a classroom with peers in an attempt to increase social communication, language abilities, and other skills. Parents will also receive education sessions 1-3 times per month for 1-2 hours each. Treatment will last for 6 months.

Treatment:

Behavioral: Social Communication

Parent Training

Active Comparator group

Description:

Parents are taught strategies on how to interact with their children to increase their skills. Parent training sessions are given 2 times a month at our center and once a month at home for 60-90 minutes each. Treatment will last for 6 months.

Treatment:

Behavioral: Social communication