NCT05853861Recruiting
Promoting Early Intervention Timing and Attention to Language
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
The proposed study (PETAL: Promoting Early intervention Timing and Attention to Language) aims to determine the timing of intervention among infants with Increased Likelihood for Autism (ILA; at risk for autism by virtue of having an older sibling with autism) on communication and language outcomes at 24 months. Results of this study will determine when (9 vs 12 vs 15 months), and based on which measures (brain, language, or their combination) to augment parental support with a specialized parent-mediated coaching intervention for optimal outcomes on communication and language at 24 months. Children will be recruited at 6-8 months of age and will begin with entry assessments. All children will first begin with the MONITOR condition (using Ages \& Stages Questionnaire (ASQ-3) and activity cards. Then when the child is 9 months, they will be randomized to continue with MONITOR condition or COACH condition (i.e. JASPER Babble) after second set of assessments. There are a total of 6 assessment timepoints (6-8 months of age, 9 months of age, 12 months of age, 15 months of age, 18 months of age, and 24 months of age). At time points of 9months and 12 months, the child will be randomized to COACH or MONITOR conditions. Once the child is randomized to COACH condition, they will continue with that condition until they terminate the study at 24 months. At the 15 months timepoint, there will no longer be a randomization. Children that were in the MONITOR condition will change to the COACH condition until they terminate the study.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 25 Apr 2023
- Start date
- 25 Nov 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Autism
- NCT number
- NCT05853861
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 25 Nov 2024 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Infant is expected to have surgery over the next year
Other illness
- Infants who have seizures and are not stable on anti-seizure medication
- 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).
Age
- In addition, infants who are premature or less than 34 weeks (gestational age \<34 weeks) will be excluded.
Who the study is looking for
- 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.
Age in the registry: 6 months to 8 months · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Massachusetts Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.