Virtual Family Navigation for Autism
(ROOTS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether virtual Family Navigation can help toddlers in rural North Carolina begin autism treatment more quickly and improve their development. Families will either receive virtual guidance from a trained navigator to access autism services or receive only educational materials. The trial will compare both groups to determine if guided support results in faster treatment and better outcomes for the toddlers and their caregivers. It suits families with toddlers recently diagnosed with autism who live in rural North Carolina and have phone or internet access. As an unphased trial, this study allows families to contribute to innovative research that could enhance autism care in rural areas.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that Virtual Family Navigation is safe for toddlers with autism?
Research has shown that Family Navigation (FN) services for families with children who have autism are generally well-received. Studies indicate that these services help parents become more involved and reduce their stress, with no major negative effects reported. This suggests that FN is safe for families, especially since it is an online service and doesn't involve medication or physical procedures. FN primarily provides support and information to help families access autism intervention services. This support has improved care and outcomes for children and their families.12345
Why are researchers excited about this trial?
Researchers are excited about Virtual Family Navigation for autism because it offers a new way to support families through personalized virtual guidance. Unlike traditional methods that typically provide static educational materials, this approach involves up to four interactive sessions with a trained navigator, conducted via phone or Zoom. This direct, individualized assistance helps caregivers effectively identify and access early intervention services, potentially leading to better outcomes for children with autism. The virtual format also makes it more accessible for families who may face geographic or time constraints, setting it apart from more conventional in-person support options.
What evidence suggests that Virtual Family Navigation is effective for autism?
Research shows that Family Navigation (FN) programs, a treatment in this trial, can assist families dealing with autism spectrum disorder (ASD). Studies have found that FN leads to earlier ASD diagnosis, particularly for children from low-income or minority families. Evidence also suggests that FN services increase parents' confidence and involvement in their child's care. Additionally, FN reduces stress for caregivers and enhances the overall well-being of families managing autism. These findings highlight how FN supports families in obtaining early help for their children with autism.12367
Who Is on the Research Team?
Kelly Caravella, PhD
Principal Investigator
Carolina Institute for Developmental Disabilities
Are You a Good Fit for This Trial?
This trial is for caregivers and their toddlers up to 4 years old living in rural North Carolina, who have a new autism diagnosis or are awaiting one. Caregivers must be over 18 and speak fluent English.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Family Navigation
Caregivers receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All sessions are delivered virtually via phone/Zoom.
Follow-up
Participants are monitored for developmental outcomes and caregiver well-being at 6 months and 18 months post-diagnosis.
What Are the Treatments Tested in This Trial?
Interventions
- Virtual Family Navigation
Trial Overview
The study tests if telehealth-based Family Navigation can speed up enrollment in autism interventions for toddlers after diagnosis, improve developmental outcomes, and enhance caregiver well-being compared to just receiving educational materials.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.
The comparison condition ("Educational Materials") consists of providing the child's caregivers with information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations). Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
The Foundation of Hope for Research and Treatment of Mental Illness
Collaborator
Citations
1.
publications.aap.org
publications.aap.org/pediatrics/article/155/4/e2024067947/201180/Family-Navigation-Programs-for-Children-WithFamily Navigation Programs for Children With Autism ...
This scoping review aimed to map the current evidence to describe the characteristics and synthesize the effectiveness of FN programs for children with ASD.
Effect of Family Navigation on Diagnostic Ascertainment ...
Family navigation is a promising approach to improve early ASD diagnosis among children from low-income, racial/ethnic minority families.
Project AFECT (Autism Family Empowerment Coaching ...
This is a prospective clinical effectiveness study of Project AFECT, an intervention combining parent coaching and family navigation. Parents who meet inclusion ...
Virtual Family Navigation for Autism (EASE Trial)
Family navigation (FN) services for families of children with autism spectrum disorder (ASD) showed improvements in parent activation and reduced caregiver ...
A mixed-methods process evaluation of Family Navigation ...
The aim of this study was to identify potential failures in implementing Family Navigation for children with autism spectrum disorder, using a failure modes and ...
Family navigation to increase evaluation for autism ...
Family navigation (FN), an adaptation of patient navigation that incorporates a family systems approach, improves preventive care delivery in low-income ...
Family Navigation Implementation Strategies: Improving ...
The Autism Project has learned that it is critical to have navigators who are bilingual, because having support and receiving information in a family's native ...
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