ACTIVE_NOT_RECRUITING

Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays

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

A confluence of empirical research on poverty, environmental risk factors, and brain development shows that early experiences are uniquely powerful in the first years of life, providing further impetus for early detection and intervention. Measures of early-developing social communication skills offer a viable solution for earlier detection of children with language delays and subsequent educational challenges. The investigators propose testing a new technology-supported platform with three parent-mediated intervention components for babies with early communication delays using mobile technology: 1) the Social Communication Growth Charts, a self-guided app to explore video clips illustrating early milestones and to chart their child's development; 2) Baby Navigator Webinar, webinars open to the public designed as a companion to the Growth Charts; and 3) Mobile Coaching, individual weekly telehealth sessions to coach parents in their everyday activities. The investigators propose using a multiphase optimization strategy (MOST) as a framework for development, optimization, and evaluation of our dynamic web intervention platform. The Investigators will recruit 80 children with communication delays at 12-18 months of age. Families will be invited to the Social Communication Growth Charts bundled with the Baby Navigator Webinar. At 18-21 months, slow responders will be randomized to continue the bundle with or without Mobile Coaching, and responders will continue the bundle. This study will enhance the sustainability, scalability, and lead to transformative changes to efficiently and effectively improve healthcare delivery via the use of innovative technology, an implementation science methodology, and user-friendly tools and web platform.

Official Title

Effects of Technology-Supported Social Communication Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays: Preliminary Study

Quick Facts

Study Start:2021-07-14
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05215145

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:12 Months to 18 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * child over 18 months of age at beginning of study
  2. * child shows 5 or more red flags for autism based on the home observation video scored with the SORF (Systematic Observation of Red Flags) of ASD
  3. * parent/child dyad does not speak English or Spanish
  4. * family lives outside of the United States
  5. * parent does not agree to be video recorded as part of the study

Contacts and Locations

Principal Investigator

Amy Wetherby, PhD
PRINCIPAL_INVESTIGATOR
Florida State University Autism Institute

Study Locations (Sites)

Florida State University Autism Institute
Tallahassee, Florida, 32309
United States

Collaborators and Investigators

Sponsor: Florida State University

  • Amy Wetherby, PhD, PRINCIPAL_INVESTIGATOR, Florida State University Autism Institute

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 Date2021-07-14
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-07-14
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Social Communication
  • Pediatrics
  • Infant Development
  • Child Development

Additional Relevant MeSH Terms

  • Social Communication