RECRUITING

Promoting Early Intervention Timing and Attention to Language

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 (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.

Official Title

Promoting Early Intervention Timing and Attention to Language

Quick Facts

Study Start:2024-07-01
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05853861

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 8 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * This study will recruit approximately 140 infants ages 6-8 months of age who are younger siblings of children with ASD.
  2. * Both males and females are eligible for study participation and will be recruited.
  3. * 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.
  1. * Infants who have seizures and are not stable on anti-seizure medication
  2. * Infant is expected to have surgery over the next year
  3. * Infant has associated physical disorders, and/or co-morbid with other syndromes or diseases.
  4. * 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).
  5. * In addition, infants who are premature or less than 34 weeks (gestational age \<34 weeks) will be excluded.

Contacts and Locations

Study Contact

Connie Kasari, PhD
CONTACT
310-825-8342
kasari@gseis.ucla.edu
Consuelo Garcia, BS
CONTACT
562-301-6141
cogarcia@mednet.ucla.edu

Study Locations (Sites)

UCLA
Los Angeles, California, 90095
United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655-0002
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

  • autism
  • siblings
  • JASPER
  • speech
  • intervention

Additional Relevant MeSH Terms

  • MONITOR
  • COACH