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A Randomized Clinical Trial for Toddlers With ASD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01008800
Enrollment
196
Registered
2009-11-06
Start date
2009-09-30
Completion date
2013-02-28
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder, language, social, toddlers

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.

Interventions

BEHAVIORALSocial 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.

BEHAVIORALSocial 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).

Sponsors

HRSA/Maternal and Child Health Bureau
CollaboratorFED
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Months to 33 Months
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

Design outcomes

Primary

MeasureTime frame
Communication and Symbolic Behavior Scalesimmediately after treatment ends and 6 months after treatment ends

Secondary

MeasureTime frame
Mullen Scales of Early Learningimmediately after treatment ends and 6 months after treatment ends

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026