Early intervention for infants at risk for autism
Promoting Early Intervention Timing and Attention to Language
NA · University of California, Los Angeles · NCT05853861
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 6 Months to 8 Months |
| Sex | All |
| Sponsor | University of California, Los Angeles (other) |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT05853861 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants aged 6-8 months who are younger siblings of children with autism and come from low-income families.
Not a fit: Patients who have seizures, associated physical disorders, or other significant health issues may not benefit from this study.
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 performed: Other studies have shown promise in early intervention approaches for autism, but this specific timing and methodology is relatively novel.
Eligibility criteria
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 this trial is running
Los Angeles, California and 1 other locations
- UCLA — Los Angeles, California, United States (RECRUITING)
- University of Massachusetts Medical Center — Worcester, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Connie Kasari, PhD
- Email: kasari@gseis.ucla.edu
- Phone: 310-825-8342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MONITOR, COACH, autism, siblings, JASPER, speech, intervention