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OpenTrials
Completed

NCT Number: NCT01008800

A Randomized Clinical Trial for Toddlers With ASD

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.

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Key information

Age range

22 month–33 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Communication

Behavioral

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.

Primary outcomes

  1. Communication and Symbolic Behavior Scales

    Time frame: immediately after treatment ends and 6 months after treatment ends

Secondary outcomes

  1. Mullen Scales of Early Learning

    Time frame: immediately after treatment ends and 6 months after treatment ends

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 6, 2009
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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