Baby Navigator Intervention for Social Communication Disorder

(CD-R21 Trial)

Overseen By Amy Wetherby, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Over 18 months, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to evaluate a new technology-supported platform, the Baby Navigator Intervention, designed to assist parents of babies with early communication delays in engaging with their child's development. The platform includes an app featuring video clips of developmental milestones, webinars, and personalized weekly coaching via telehealth. The researchers aim to determine how these tools can improve early detection and intervention for communication delays, potentially benefiting children's education and social skills. Families with children aged 12-18 months who show early signs of communication delay may be suitable candidates for this trial. As an unphased trial, participants contribute to innovative research that may enhance early childhood development strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intervention is safe for babies with early communication delays?

Research has shown that the Baby Navigator Intervention is safe and easy to use. It employs mobile technology and includes tools like Social Communication Growth Charts and webinars to help parents monitor and support their child's development. These tools integrate into daily routines, making them stress-free for families.

Early results suggest that families find the intervention manageable. Parents can choose their level of participation, which enhances their comfort. No reports of negative effects have been directly linked to the Baby Navigator tools, likely because the focus is on education and support rather than medical treatments.

Overall, the Baby Navigator Intervention appears to be a safe choice for families wanting to support their child's social communication development. Its emphasis on parental involvement and flexible use has been well-received by users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Baby Navigator Intervention because it focuses on empowering parents to support their child's social communication development in a uniquely interactive way. Unlike traditional therapies that might rely more on clinical settings, this intervention uses the Early Social Interaction (ESI) model, where trained coaches guide parents to integrate communication-building activities into everyday routines and environments. Additionally, the use of telehealth platforms for weekly sessions makes it more accessible, flexible, and convenient for families to engage in the treatment process, potentially leading to more consistent and personalized support for each child.

What evidence suggests that this trial's treatments could be effective for social communication disorder?

Research has shown that the Baby Navigator Intervention, which participants in this trial may receive, could significantly improve social communication in young children with delays. The Social Communication Growth Charts, part of the Baby Navigator Bundle, enable parents to track their child's progress using video examples of early milestones. The FIRST WORDS® Project, recognized for its success in early detection of communication issues, created this tool. Studies of similar parent-focused programs have demonstrated that involving parents in daily activities can greatly enhance children’s language and social skills. Although this new platform uses technology, early feedback indicates it is easy to use and effective in helping families support their child's development. ^{1 3 4 5 6}

Who Is on the Research Team?

Amy Wetherby, PhD

Principal Investigator

Florida State University Autism Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child screened positive for communication delay between 12-18 months.

My child scored below the 10th percentile on the CSBS CQ at 12-18 months.

agrees to be in the intervention study

Exclusion Criteria

I do not consent to being video recorded for the study.

A child shows at least 5 signs of autism based on a video taken at home and evaluated using the SORF (Systematic Observation of Red Flags) of ASD.

family lives outside of the United States

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Baseline Assessment

Baseline assessments including home observation video and caregiver questionnaire

1-2 weeks

1 visit (virtual)

Intervention

Participants engage with the Baby Navigator Bundle, including Social Communication Growth Charts and webinars. Slow responders may receive additional Mobile Coaching.

6-12 months

Weekly virtual sessions

Follow-up

Participants are monitored for changes in social communication skills and parent responsiveness

6-12 months

Periodic virtual assessments

What Are the Treatments Tested in This Trial?

Interventions

• Baby Navigator Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Baby Navigator Bundle + Individual-ESI Active Control 2 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 Bundle Active Control 1 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.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Duquesne University

Collaborator

Trials

33

Recruited

2,500+

Published Research Related to This Trial

Early communication impairments are common concerns for parents of young children with autism spectrum disorder (ASD), and this study identified different growth trajectories in language and gesture acquisition among high-risk and low-risk siblings during the first 2 years of life.

The findings suggest that slower language and gesture development in infants who later receive an ASD diagnosis is linked to early developmental skills and behavioral symptoms, highlighting the importance of monitoring communication milestones in high-risk infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in Verbal and Nonverbal Communication in Infants at Risk for Autism Spectrum Disorder: Predictors and Outcomes. Franchini, M., Duku, E., Armstrong, V., et al.[2019]

The Map4speech mobile application effectively trains parents in naturalistic language interventions for children with autism, showing over 85% procedural integrity in parents' techniques after training.

Children of parents using the app demonstrated increased spontaneous word and gesture use, indicating that mobile technology can enhance communication outcomes in young children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of behavior modeling training in a mobile app parent training program to improve functional communication of young children with autism spectrum disorder. Law, GC., Neihart, M., Dutt, A.[2019]

The Early Communication Indicator (ECI) effectively tracks the development of communication skills in infants and toddlers aged 6 to 42 months, highlighting unique growth patterns in key skills like gestures and vocalizations.

Understanding the specific trajectories of these foundational skills can enhance the sensitivity and utility of the ECI, aiding practitioners in making informed decisions about interventions for individual children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence of a Continuum in Foundational Expressive Communication Skills. Greenwood, CR., Walker, D., Buzhardt, J., et al.[2021]

The Eye to I© intervention model significantly improved social skills and communication in 11 children with autism, aged 2-6 years, as evidenced by increased scores on standardized assessments after the therapy.

Participants demonstrated greater engagement in more complex social play stages, indicating that the intervention effectively supported key areas of autism diagnosis related to communication and social interaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring social stages of play through eye to I© intervention model. Schuchert, SA., Khattar, S., Tekkar, P., et al.[2023]

The ASDetect mobile application, based on the Social Attention and Communication Surveillance (SACS) tool, shows strong psychometric properties for early detection of Autism Spectrum Conditions (ASC) in children aged 12 to 24 months, potentially bridging the gap in timely identification, especially in low-resourced settings.

The application not only helps in assessing the likelihood of ASC but also enhances parental knowledge and communication with health professionals, which can lead to better outcomes for children and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for an evaluation of ASDetect - a Mobile application for the early detection of autism. Barbaro, J., Yaari, M.[2021]

The study demonstrated that using an iPad® with Proloquo2Go™ can effectively teach multistep social-communication skills to children with autism spectrum disorder (ASD) and other developmental disabilities, as shown in three participants aged 7 to 10 years.

Systematic instruction led to varying degrees of success in skills such as making requests, expressing gratitude, and answering personal questions, highlighting the potential of augmentative and alternative communication (AAC) devices in enhancing social interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Systematic Instruction in Teaching Multistep Social-Communication Skills to Children with Autism Spectrum Disorder Using an iPad. Alzrayer, NM., Banda, DR., Koul, RK.[2019]

The Therapeutic Outcomes By You app, used in a three-month randomized controlled trial, led to significant improvements in language and social communication skills for children with autism spectrum disorder.

These improvements were maintained for at least 12 months after the intervention ended, indicating the long-term efficacy of the app in supporting children with autism in regional Australia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A twelve-month follow-up of an information communication technology delivered intervention for children with autism spectrum disorder living in regional Australia. Parsons, D., Vaz, S., Lee, H., et al.[2021]

The Social Communication Intervention Programme (SCIP) was effective for children aged 5-11 with Social (Pragmatic) Communication Disorder or High-Functioning Autism, as nearly all participants showed progress in their communication goals after 20 therapy sessions.

The study demonstrated the feasibility of using a parent preference-based outcome measure, with 82.5% of parent comments aligning with their ratings of progress, indicating that this approach could be valuable for assessing treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a parent preference-based outcome measure after intensive communication intervention for children with social (pragmatic) communication disorder and high-functioning autism spectrum disorder. Adams, C., Gaile, J.[2021]

Citations

1. trialx.com trialx.com/clinical-trials/listings/234469/baby-navigator-intervention-to-improve-outcomes-of-toddlers-with-communication-delays/

Baby Navigator Intervention to Improve Outcomes of ... Baby Navigator is a web platform with three parent-mediated intervention components using mobile technology: 1) the Social Communication Growth ...

2. scgc.babynavigator.com scgc.babynavigator.com/about

Social Communication Growth Charts - SCGC – Baby Navigator The Social Communication Growth Charts were developed by the FIRST WORDS® Project at Florida State University to teach families of infants and toddlers ...

3. reporter.nih.gov reporter.nih.gov/project-details/9863072

Validation of the Social Communication CheckUp and ... This new screening tool is designed for universal screening at well-child visits at 9, 12, 15, 18, 21, and 24 months of age to screen for communication delay ...

4. my.babynavigator.com my.babynavigator.com/pdf/en/Baby-Navigator-Portal-Research-Statement.pdf

FIRST WORDS® Project • College of Medicine - Baby Navigator We will use SoCo Growth Chart data, SoCo CheckUp scores, usage data from tools and resources accessed via the Baby Navigator Portal, and information from the ...

5. babynavigator.com babynavigator.com/assets/About-Baby-Navigator/About_Baby_Navigator_en.pdf

What every parent needs to know - Baby Navigator Chart your baby's social communication mile- stones every 2 months starting at 3 months to monitor which milestones they've reached and which ones to look for ...

6. scgc.babynavigator.com scgc.babynavigator.com/ages/11-12Months

Milestones that Matter Most: 11-12 Months Key milestones include using gestures, speech sounds, functional actions with objects, social sharing, and sharing enjoyment with transitions.