Intervention to help toddlers with communication delays
Effects of Technology-Supported Social Communication Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays: Preliminary Study
This study is testing a new program that helps toddlers with communication delays by providing parents with an app, webinars, and coaching to improve their child's language skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 12 Months to 18 Months |
| Sex | All |
| Sponsor | Florida State University Academic / other |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT05215145 on ClinicalTrials.gov |
What this trial studies
This intervention aims to improve outcomes for toddlers with communication delays by utilizing a technology-supported platform that includes three components: a self-guided app with social communication growth charts, public webinars, and individual telehealth coaching sessions for parents. The program targets early detection and intervention for children showing signs of language delays, particularly focusing on families from lower socioeconomic backgrounds. By engaging parents in their child's development through these resources, the study seeks to enhance communication skills and prepare children for educational success.
Who should consider this trial
Good fit: Ideal candidates for this study are parent-child dyads where the child is between 12-18 months old and has been screened positive for communication delays.
Not a fit: Patients who may not benefit include children over 18 months of age or those showing significant red flags for autism.
Why it matters
Potential benefit: If successful, this intervention could significantly improve communication skills in toddlers, leading to better educational outcomes.
How similar studies have performed: Other studies have shown success with similar early intervention approaches, emphasizing the importance of timely support for communication development.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for parent/child dyads: * parent completes the SoCo CheckUp (available at https://babynavigator.com) screening at 12-18 months of age and child has a positive screen for communication delay * parent completes the CSBS CQ and child falls below the 10th percentile at 12-18 months * parent records and submits/uploads a home observation video at 12-18 months * speaks English or Spanish at home * agrees to be in the intervention study Exclusion Criteria: * child over 18 months of age at beginning of study * 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 * parent/child dyad does not speak English or Spanish * family lives outside of the United States * parent does not agree to be video recorded as part of the study
Where this trial is running
Tallahassee, Florida
- Florida State University Autism Institute — Tallahassee, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Amy Wetherby, PhD — Florida State University Autism Institute
- Study coordinator: Sherrie Hajek, MA
- Email: sherrie.hajek@med.fsu.edu
- Phone: 850-488-4072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.