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NCT05853861: PETAL

Promoting Early Intervention Timing and Attention to Language

Recruiting now NA Last updated 31 March 2026
What this trial tests

NA trial testing JASPER Babble in MONITOR in 140 participants. Currently enrolling.

Timeline
25 November 2024
Primary endpoint
31 December 2027
30 June 2028

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment140
Start date25 November 2024
Primary completion31 December 2027
Estimated completion30 June 2028
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

Adults 6 Months to 8 Months, any sex, with MONITOR or COACH. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University of California, Los Angeles trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing