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A Randomized Clinical Trial for Toddlers With ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01008800
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : September 3, 2020
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Social Communication Behavioral: Social communication Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parent-mediated vs Center-based Intervention for Toddlers With ASD: An RCT
Study Start Date : September 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Center-Based classroom intervention
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.
Behavioral: Social Communication
The Center-Based classroom intervention focuses on providing children with an invigorating, motivating learning environment in which emerging skills and knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement week may offer the children experiences that they would not otherwise have (Ramey & Ramey, 1998). Parent training sessions will focus on strategies aimed at improving child social engagement and communication and on topics related to autism characteristics, learning styles, interventions, and resources.

Active Comparator: Parent Training
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.
Behavioral: Social communication
Parent training sessions will focus on teaching parents strategies for enhancing their child's social engagement and communication. Since parents will be using these strategies across all activities throughout the day, there is an increased likelihood of generalization. For parents of minority and underserved children, this may be the first exposure to responsive interaction strategies (Rudy & Grusec, 2001).

Primary Outcome Measures :
  1. Communication and Symbolic Behavior Scales [ Time Frame: immediately after treatment ends and 6 months after treatment ends ]

Secondary Outcome Measures :
  1. Mullen Scales of Early Learning [ Time Frame: immediately after treatment ends and 6 months after treatment ends ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Months to 33 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01008800

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United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
HRSA/Maternal and Child Health Bureau
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Principal Investigator: Rebecca Landa, PhD, CCC-SLP Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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Responsible Party: Rebecca Landa, Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Identifier: NCT01008800    
Other Study ID Numbers: R40 MC 15594-01
NA_00030329 ( Other Identifier: Johns Hopkins Medicine IRB # )
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Keywords provided by Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
Autism Spectrum Disorder
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders