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NCT05853861 · ClinicalTrials.gov registry record · NA
Promoting Early Intervention Timing and Attention to Language
A NA study of MONITOR and COACH, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 2
- Study locations
NCT05853861 is a NA study of MONITOR and COACH that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 140 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT05853861, a NA study of MONITOR and COACH, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 2
- Study locations
Study 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 (incorporates JASPER intervention and Babble Bootcamp) 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.
Interventions
- BEHAVIORAL JASPER
- BEHAVIORAL Babble Bootcamp
Study Locations (2)
California
- UCLA - Los Angeles
Massachusetts
- University of Massachusetts Medical Center - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2024-11-25 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05853861
The ClinicalTrials.gov registry entry for NCT05853861 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with MONITOR appearing as the primary indexed condition, and to 2 interventions - of which JASPER is the first listed.
NCT05853861 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05853861 about?
NCT05853861 is a clinical study titled "Promoting Early Intervention Timing and Attention to Language". 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 ...
What is the current status of trial NCT05853861?
This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2024-11-25. Estimated completion is 2028-06-30.
What conditions does trial NCT05853861 study?
This clinical trial studies the following conditions: MONITOR, COACH.
What interventions are being tested in trial NCT05853861?
The interventions under investigation include: JASPER (BEHAVIORAL), Babble Bootcamp (BEHAVIORAL).
Who is sponsoring clinical trial NCT05853861?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05853861 being conducted?
This trial has 2 study locations across California, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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