Status:
RECRUITING
"Opt-In" Early Intervention Program for Children Waiting to Receive an Autism Diagnosis
Lead Sponsor:
Drexel University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Autism
Eligibility:
All Genders
16-48 years
Phase:
NA
Brief Summary
A growing body of literature documents the benefits of parent-mediated interventions for autism starting early in life . However, the median age of diagnosis in the US continues to be 49 months. Even ...
Detailed Description
BACKGROUND. The increasing prevalence of autism spectrum disorder (ASD), now at 1 in 36 children, highlights an urgent need for early interventions that are both effective and efficient, given the soc...
Eligibility Criteria
Inclusion Criteria:
- age between 16-48 months,
- parental consent
- being on a waitlist to receive a formal diagnostic evaluation at the time of parent consent due to autism concerns
- parents speak English
- an initial score of 8 or greater or Follow-Up score of 2 or greater on the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up (M-CHAT-R/F; Robins et al., 2014) as an indication of autism likelihood.
Exclusion Criteria:
- having already received a formal diagnosis of autism
- enrollment in early intervention programs delivering more than 5 h per week of evidence-based autism-specific interventions at the time of consent
- child has a gestational age less than 36 weeks associated with a birth weight less than 2500 g
- the child is not yet walking, or has severe hearing and/or vision impairment that is uncorrected with aids, or known neurological disorder or genetic syndrome (e.g., Down syndrome).
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07081724
Start Date
August 25 2025
End Date
December 1 2029
Last Update
January 28 2026
Active Locations (1)
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1
A.J. Drexel Autism Institute
Philadelphia, Pennsylvania, United States, 19104