NCT05853861 Promoting Early Intervention Timing and Attention to Language
| NCT ID | NCT05853861 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | MONITOR |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2024-11-25 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05853861 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 8 Months, studying MONITOR. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05853861 currently recruiting?
Yes, NCT05853861 is actively recruiting participants. Contact the research team at kasari@gseis.ucla.edu for enrollment information.
Where is the NCT05853861 trial being conducted?
This trial is being conducted at Los Angeles, United States, Worcester, United States.
Who is sponsoring the NCT05853861 clinical trial?
NCT05853861 is sponsored by University of California, Los Angeles. The trial plans to enroll 140 participants.