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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Baby Navigator Intervention treatment for Social Communication Disorder?

Research shows that mobile applications with feedback, like those used in the Baby Navigator Intervention, can effectively improve communication skills in children with autism. Additionally, interventions that involve parent training and coaching have been shown to enhance children's social and communication skills, suggesting potential benefits for similar approaches in the Baby Navigator Intervention. ^{1 2 3 4 5}

How is the Baby Navigator Intervention treatment different from other treatments for social communication disorder?

The Baby Navigator Intervention is unique because it combines social communication growth charts, webinars, and mobile coaching to help parents understand and support their child's early social-communication development, which is not typically offered in standard treatments for social communication disorders. ^{1 2 6 7 8}

Research Team

Amy Wetherby, PhD

Principal Investigator

Florida State University Autism Institute

Eligibility Criteria

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

I speak English or Spanish at home.

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.

Exclusion Criteria

My child is older than 18 months.

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evidence of a Continuum in Foundational Expressive Communication Skills. [2021]

2. England 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. [2019]

3. United States 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Exploring social stages of play through eye to I© intervention model. [2023]

5. United States 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Study protocol for an evaluation of ASDetect - a Mobile application for the early detection of autism. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Variability in Verbal and Nonverbal Communication in Infants at Risk for Autism Spectrum Disorder: Predictors and Outcomes. [2019]

8. England 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. [2019]