Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05853861

Conditions

MONITOR

COACH

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

JASPER Babble

Study Details

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.

Conditions

MONITOR

COACH

Study ID

NCT05853861

Start date

Nov 25, 2024

Status verified date

Mar, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 9 month coaching

Participants receive JASPER Babble coaching at 9 months of age. Prior to 9 months, participants are just being monitored.

experimental: 12 month coaching

Participants receive JASPER Babble coaching at 12 months of age. Prior to 12 months, participants are just being monitored.

experimental: 15 month coaching

Participants receive JASPER Babble coaching at 15 months of age. Prior to 15 months, participants are just being monitored.

Interventions

JASPER Babble

JASPER Babble is an evidence based early intervention that focuses on the core social communication and engagement skills of young children that are important to improvements in communication and language.

Primary outcome measure

  • Mullen Early Learning Scales (MSEL) [ Time Frame: child's 6,9,12,15,18 and 24 months of age ]

Central Contacts and Locations

Central contacts

Connie Kasari, PhD

310-825-8342kasari@gseis.ucla.edu

Consuelo Garcia, BS

562-301-6141cogarcia@mednet.ucla.edu

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Connie Kasari, PhD

University of Massachusetts Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655-0002

Contacts

Sarabeth Broder-Fingert, MD

sarabeth.broderfingert1@umassmed.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • autism
  • siblings
  • JASPER
  • speech
  • intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-03-31.