Status:

COMPLETED

Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families

Lead Sponsor:

Emory University

Collaborating Sponsors:

National Institute of Mental Health (NIMH)

Conditions:

Autism Spectrum Disorder

Eligibility:

All Genders

6-6 years

Phase:

NA

Brief Summary

This early treatment project is designed to address two significant public health challenges - the need for validated, manualized, treatments for young children with Autism Spectrum Disorder (ASD) tha...

Detailed Description

Most children with autism spectrum disorders (ASD) require special education at school age at staggering expenses to the educational system. The average annual cost for educating a child with ASD, bas...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for Stage 1:
  • Have an ASD sibling who is in the Emory Autism Center of Excellence.
  • Inclusion Criteria for Stage 2:
  • Nonresponse to Stage 1 intervention; a "nonresponder" is defined as infants who show early signs of autism and communication delay.
  • Shows early signs of ASD, defined by a positive score on the Infant-Toddler Checklist (ITC) and at least two of the following autism screening tools: Early Screening for Autism and Communication Disorders (ESAC), Systematic Observation of Red Flags of ASD (SORF) Clinic, or SORF-Home.
  • Exclusion Criteria:
  • Parent/caregiver declines to participate.

Exclusion

    Key Trial Info

    Start Date :

    February 1 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 8 2024

    Estimated Enrollment :

    269 Patients enrolled

    Trial Details

    Trial ID

    NCT03307057

    Start Date

    February 1 2018

    End Date

    October 8 2024

    Last Update

    December 19 2025

    Active Locations (1)

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    Marcus Autism Center

    Atlanta, Georgia, United States, 30329