Resources for Optimizing Outcomes in Toddlers on the Spectrum (ROOTS)

University of North Carolina (UNC)

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Educational Materials; Behavioral: Virtual Family Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT07086781

25-1164

Details and patient eligibility

About

The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for toddlers under the age of 4 living in Rural NC after their initial diagnosis of autism.

The main questions it aims to answer are:

Does Family Navigation decrease the time to initiation of intervention for rural toddlers with autism?

Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism?

Does Family Navigation improve caregiver well-being?

Caregivers in the Family Navigation condition will receive 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.

Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children up to 48 months who have a new diagnosis of autism (within the last month) or who are waiting for a diagnosis of autism AND their caregiver.
• Live in North Carolina, in one of the 78 rural counties.
• Caregiver must be over the age of 18
• The caregiver must speak conversationally fluent English.

Exclusion criteria

• No access to a telephone or internet connection for phone calls or video conferencing.
• Diagnosis of autism spectrum disorder is ruled out in the child.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Family Navigation

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Family Navigation

Educational Materials

Active Comparator group

Description:

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.

Treatment:

Behavioral: Educational Materials