Status:
ACTIVE_NOT_RECRUITING
Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays
Lead Sponsor:
Florida State University
Collaborating Sponsors:
Duquesne University
Conditions:
Social Communication
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
A confluence of empirical research on poverty, environmental risk factors, and brain development shows that early experiences are uniquely powerful in the first years of life, providing further impetu...
Detailed Description
BACKGROUND AND AIMS: About one in three children in the U.S. enter kindergarten unprepared to learn and lacking sufficient communication skills. Despite the federal mandate for early intervention (EI...
Eligibility Criteria
Inclusion
- Inclusion Criteria for parent/child dyads:
- parent completes the SoCo CheckUp (available at https://babynavigator.com) screening at 12-18 months of age and child has a positive screen for communication delay
- parent completes the CSBS CQ and child falls below the 10th percentile at 12-18 months
- parent records and submits/uploads a home observation video at 12-18 months
- speaks English or Spanish at home
- agrees to be in the intervention study
- Exclusion Criteria:
- child over 18 months of age at beginning of study
- child shows 5 or more red flags for autism based on the home observation video scored with the SORF (Systematic Observation of Red Flags) of ASD
- parent/child dyad does not speak English or Spanish
- family lives outside of the United States
- parent does not agree to be video recorded as part of the study
Exclusion
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05215145
Start Date
July 14 2021
End Date
December 31 2025
Last Update
September 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida State University Autism Institute
Tallahassee, Florida, United States, 32309