Clinical trial Recruiting at 2 sites Interventional Ages 6 Months to 8 Months

Early intervention for infants at risk for autism

Official title: Promoting Early Intervention Timing and Attention to Language

Run by University of California, Los Angeles · NCT05853861 · Data updated 2026-11-12

This study is testing the best time to start helping babies who might be at risk for autism because they have an older sibling with the condition, to see if early coaching can improve their communication skills.

Quick facts

Study typeInterventional
Ages6 Months to 8 Months
SexAll
Enrollment140 (estimated)
SponsorUniversity of California, Los Angeles
Academic / other
Locations2 sites (Los Angeles, California and 1 other locations)
StatusRecruiting
StartedNovember 25, 2024
Main results expectedDecember 31, 2027
Study endsJune 30, 2028
Registry record updatedMarch 31, 2026
Trial IDNCT05853861 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are infants aged 6-8 months who are younger siblings of children with autism and come from low-income families.

Probably not a fit

Patients who have seizures, associated physical disorders, or other significant health issues may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine the optimal timing for intervention among infants at increased likelihood for autism due to having an older sibling with autism. Infants aged 6-8 months will be recruited and assessed before being randomized to either a monitoring condition or a coaching intervention that incorporates JASPER and Babble Bootcamp. The study will utilize a Sequential Multiple Assignment Randomized Trial (SMART) design to evaluate communication and language outcomes at 24 months based on different intervention timings. The goal is to inform clinical decision-making regarding the best time to transition to more intensive interventions.

Why it matters

Potential benefit: If successful, this study could enhance communication and language outcomes for infants at risk for autism.

How similar studies have gone: Other studies have shown promise in early intervention approaches for autism, but this specific timing and methodology is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* This study will recruit approximately 140 infants ages 6-8 months of age who are younger siblings of children with ASD.
* Both males and females are eligible for study participation and will be recruited.
* Family income is under the very low income described under the Department of Housing and Community DevelopmentDivision of Housing Policy Agreement for the city of Los Angeles.

Exclusion Criteria:

* Infants who have seizures and are not stable on anti-seizure medication
* Infant is expected to have surgery over the next year
* Infant has associated physical disorders, and/or co-morbid with other syndromes or diseases.
* All of the children will be free of additional sensory or motor impairments (e.g., Visual or hearing impairment) and othergenetic syndromes (e.g., Down Syndrome).
* In addition, infants who are premature or less than 34 weeks (gestational age \<34 weeks) will be excluded.

Where it's running

  • UCLA
    Los Angeles, California, United States
    Recruiting
  • University of Massachusetts Medical Center
    Worcester, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.