Promoting Early Intervention Timing and Attention to Language

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 8 months
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UCLA
RECRUITING
Los Angeles
Massachusetts
University of Massachusetts Medical Center
RECRUITING
Worcester
Contact Information
Primary
Connie Kasari, PhD
kasari@gseis.ucla.edu
310-825-8342
Backup
Consuelo Garcia, BS
cogarcia@mednet.ucla.edu
562-301-6141
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 140
Treatments
No_intervention: MONITOR
Participants in this arm will be provided with information to track the early development of their infants, along with specific developmentally targeted activities.
Experimental: COACH
Participants will be provided with a blended intervention of two evidence tested intervention, JASPER and Babble Bootcamp along with continued monitoring.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: University of Massachusetts, Worcester

This content was sourced from clinicaltrials.gov