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Baby Navigator Intervention for Social Communication Disorder (CD-R21 Trial)

N/A
Recruiting
Led By Amy Wetherby, PhD
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and 6-12 months after start of intervention
Awards & highlights

CD-R21 Trial Summary

This trial will test a new technology-supported platform with three parent-mediated intervention components for babies with early communication delays using mobile technology.

Who is the study for?
This trial is for toddlers aged 12-18 months with communication delays, as identified by a screening tool and home video observation. Parents must speak English or Spanish, agree to participate in the study and be recorded. Children showing strong signs of autism or living outside the U.S., or over 18 months old are excluded.Check my eligibility
What is being tested?
The trial tests a technology-supported platform aimed at improving early communication skills through three components: an app with social communication milestones (Growth Charts), public webinars (Baby Navigator Webinar), and personalized weekly telehealth coaching sessions.See study design
What are the potential side effects?
Since this intervention involves educational tools and parent coaching without medical treatments, there are no direct physical side effects expected from participating in this clinical trial.

CD-R21 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child screened positive for communication delay between 12-18 months.
Select...
My child scored below the 10th percentile on the CSBS CQ at 12-18 months.

CD-R21 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and 6-12 months after start of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and 6-12 months after start of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child social communication change over time
Parent contingent responsiveness change over time
Secondary outcome measures
Child behavior and vocabulary checklist
Standardized assessment of language

CD-R21 Trial Design

2Treatment groups
Active Control
Group I: Baby Navigator Bundle + Individual-ESIActive Control2 Interventions
At 18-21months of age, slow responders (communication delay still below the 10th percentile) will be randomized to continue the Baby Navigator Bundle with or without Individual-ESI, and responders (communication above the 10th percentile) will continue with Baby Navigator Bundle. For Individual ESI, trained coaches or family navigators will coach families using the Early Social Interaction (ESI) model. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places. Family navigators will also engage the family in the How-to Guide for Families online course. The family navigator will use zoom or other telehealth platform to meet with parents 1 time per week for 30-60 minutes per session for 6 months.
Group II: Baby Navigator BundleActive Control1 Intervention
Parent and child measures, including a home observation video, will be collected at baseline, after which study staff will use Motivational Interviewing techniques to engage families to access resources and support (Baby Navigator Bundle) when parents first learn their child has social communication/language delay. Families may use the Baby Navigator Bundle as little or as much as desired. The Baby Navigator Bundle includes: Social Communication Growth Charts and the Baby Navigator webinar series.

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
199 Previous Clinical Trials
31,611 Total Patients Enrolled
Duquesne UniversityOTHER
30 Previous Clinical Trials
2,348 Total Patients Enrolled
Amy Wetherby, PhDPrincipal InvestigatorFlorida State University Autism Institute
2 Previous Clinical Trials
321 Total Patients Enrolled

Media Library

Baby Navigator Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05215145 — N/A
Social Communication Disorder Research Study Groups: Baby Navigator Bundle + Individual-ESI, Baby Navigator Bundle
Social Communication Disorder Clinical Trial 2023: Baby Navigator Intervention Highlights & Side Effects. Trial Name: NCT05215145 — N/A
Baby Navigator Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05215145 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited to participate in this clinical trial?

"Affirmative. The details posted on clinicaltrials.gov indicate that this research endeavour is actively seeking to recruit participants, having been initially uploaded on July 14th 2021 and last refreshed on July 11th 2022. They are looking for 80 individuals from one medical site."

Answered by AI

Are there available slots for individuals to join this research?

"Affirmative. According to the clinical trial registration on clinicialtrials.gov, this medical study is actively accepting participants since July 14th 2021 and was last updated on July 11th 2022. The recruitment process aims to source 80 candidates from a single location."

Answered by AI

What criteria must a person meet to join this research endeavor?

"To qualify for this research program, subjects must be between 12 and 18 months of age with some form of social communication. Currently there is a need to recruit roughly 80 participants."

Answered by AI

Is there an upper age limit for participants enrolled in this experiment?

"The regulations of this clinical trial stipulate that the minimum age for inclusion is 12 Months, while 18 months is the maximum."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays
Amy M. Wetherby 2021. "Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05215145.
~21 spots leftby Apr 2025
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