Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays

NCT05215145 | Completed

• 2 other identifiers: STUDY00001641R21DC018128
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Communication

Keywords

Social Communication; Pediatrics; Infant Development; Child Development

Outcome Measures

Primary Outcomes (2)

• Parent contingent responsiveness change over time

  Parent contingent responsiveness will be periodically assessed using the Measure of Active Engagement and Transactional Supports (MAETS), a rating of a video-recorded home observation of parent-child interaction during everyday activities. The MAETS includes 8 AE components: participation and a productive role; predictable activities; language that follows the child's focus of attention; child initiations; balance of communicative turns; messages to support child comprehension; verbal and nonverbal models; and appropriate expectations and demands. These components align with the Research Domain Criteria (RDoC) constructs. Parents use of evidenced-based intervention strategies to promote AE comprise the TS subscale. Both subscales form a MAETS composite. Each component is scored on a 4-point scale where 0 = Absent, 1 = Emerging, 2 = Practicing, and 3 = Mastery. Total scores range from 0 to 48 and higher scores indicate that the level of parent support is better.

  Baseline, and 6-12 months after start of intervention

• Child social communication change over time

  Change in social communication skills will be periodically measured with the Communication and Symbolic Behavior Scales (CSBS) Caregiver Questionnaire. The caregiver will complete the questionnaire by reporting on their child's social communication skills. The raw scores will be summed to form a social, speech, and symbolic composite. The social composite includes emotion and eye gaze and communication and gestures; and possible composite scores range from 0 to 48. The speech composite includes sounds and words, and possible composite scores range from 0 to 40. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 51. The total summed score for all 3 composites ranges from 0 to 139. Higher scores on the composites and total indicate better social communication skills.

  Baseline, and 6-12 months after start of intervention

Secondary Outcomes (2)

• Standardized assessment of language

  Baseline, and 6-12 months after start of intervention

• Child behavior and vocabulary checklist

  Baseline, and 6-12 months after start of intervention

Study Arms (2)

Baby Navigator Bundle

ACTIVE COMPARATOR

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.

Behavioral: Baby Navigator Bundle

Baby Navigator Bundle + Individual-ESI

ACTIVE COMPARATOR

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.

Behavioral: Baby Navigator Bundle; Behavioral: Baby Navigator Bundle + Individual-ESI

Interventions

Baby Navigator Bundle BEHAVIORAL

The Baby Navigator Bundle includes 1) Baby Navigator, an online collection of resources: videos, growth charts, milestones, short articles, checklists, tools, and tips to help families promote early learning. Tools are customized to the child's age (in months). Baby Navigator can be found at https://babynavigator.com. 2) Social Communication (SoCo) Growth Charts is a self-guided app for parents of babies from birth to 24 months. Parents can watch video clips of early milestones and chart their child's social communication development. 3) Baby Navigator Webinars are held twice a month. Parents can learn how to support their child's growth from birth to 24 months. Content and videos focus on social communication milestones. Expert-led sessions cover a range of topics: gestures and sounds babies need to learn to talk, everyday activities that encourage learning, getting ahead of the Terrible Twos, and how Baby Navigator can help families.

Baby Navigator Bundle; Baby Navigator Bundle + Individual-ESI

Baby Navigator Bundle + Individual-ESI BEHAVIORAL

Continued Baby Navigator Bundle. Addition of ESI mobile coaching. ESI program planning entails identifying goals and objectives for the child and teaching strategies and supports for parents. Each session includes the following components: 1) setting the stage to develop that session's agenda and gather updates; 2) intervention implementation that must include the following steps to coach the parent: a) review the objective, b) use modeling, guided/caregiver practice, or video review to teach the strategy, c) provide specific feedback to the parent, and d) problem solving and plan for next time; steps a-d are repeated for 3-5 activities per session; and 3) summarize plans for parent implementation between sessions. Families are also invited to and guided through the Autism Navigator How-To Guide for Families online course.

Baby Navigator Bundle + Individual-ESI

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• Florida State University: lead
• Duquesne University: collaborator

Study Sites (1)

Florida State University Autism Institute

Tallahassee, Florida, 32309, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Amy Wetherby, PhD

  Florida State University Autism Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinician administering the Preschool Language Scales will be blind to group assignment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Research Professor

Model Details: The investigators are using a multiphase optimization strategy (MOST) as a framework for development, optimization, and evaluation of the feasibility and effects of our dynamic web intervention platform. The investigators will recruit 80 children (parent-child dyads) with communication delays (below the 10th percentile) 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 (communication delay still below the 10th percentile) will be randomized to continue the bundle or add Mobile Coaching, and responders will continue the bundle.

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: July 14, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)