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NCT Number: NCT07086781

Resources for Optimizing Outcomes in Toddlers on the Spectrum

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

1 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolina Institute for Developmental Disabilities

Carrboro, North Carolina, 27510, United States

Location status: Recruiting

Location contact

Kelly Caravella, PhD

CONTACT

[email protected]

2035244349

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Family Navigation

Behavioral

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.

Educational materials

Behavioral

The comparison condition ("Educational Materials") consists of providing the participant's caregivers 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.

Primary outcomes

  1. Time to initiation of autism specific intervention

    Time frame: Diagnosis to 18 months post

    The date of initiation (date 1) of autism-specific intervention will be the date that families report the first session with a therapist following the diagnosis (date 2). Time will be calculated as the number of days elapsed between these two dates (date 2 - date 1).

Secondary outcomes

  1. Caregiver Well-Being Score

    Time frame: 6 months post diagnosis

    Scores on the General Well-Being Schedule will be used to measure caregiver well-being. Total scores range from 0-110. Higher scores are indicative of more positive well-being. There are 3 proposed scoring cut-points: 0-60 reflects "severe distress", 61-72 reflects "moderate distress", and 73-110 reflects "positive well-being). The investigators will compare means and standard deviations between groups.

  2. Change in Raw Scores on Visual Reception domain of the MSEL

    Time frame: Baseline and 18 months post diagnosis

    This outcome will assess individual-level change in raw scores on the Mullen Scales of Early Learning (MSEL), Visual Reception domain. Raw scores will ne used instead of standard scores to detect meaningful change within-subject change. Standard scores in this population are known to exhibit floor effects in this population, which can obscure meaningful gains.

    Raw scores will be analyzed as continuous variables. The investigators will report change scores (follow-up minus baseline), individual trajectories, and summary statistics (mean, SD). Where appropriate, linear mixed-effects models or other growth modeling approaches will be used to account for within-subject variability.

    Higher scores on the MSEL indicate greater developmental progress. Raw scores on the Visual Reception domain range from 0-50.

  3. Change in Raw Scores on Expressive Language domain of the MSEL

    Time frame: Baseline and 18 months post diagnosis

    This outcome will assess individual-level change in raw scores on the Mullen Scales of Early Learning (MSEL), Expressive Language domain. Raw scores will be used instead of standard scores to detect meaningful change within-subject change. Standard scores in this population are known to exhibit floor effects in this population, which can obscure meaningful gains.

    Raw scores will be analyzed as continuous variables. The investigators will report change scores (follow-up minus baseline), individual trajectories, and summary statistics (mean, SD). Where appropriate, linear mixed-effects models or other growth modeling approaches will be used to account for within-subject variability.

    Higher scores on the MSEL indicate greater developmental progress. Raw scores on the Expressive Language domain range from 0 - 50.

  4. Change in Raw Scores on Receptive Language domain of the MSEL

    Time frame: Baseline and 18 months post diagnosis

    This outcome will assess individual-level change in raw scores on the Mullen Scales of Early Learning (MSEL), Receptive Language domain. Raw scores will be used instead of standard scores to detect meaningful change within-subject change. Standard scores in this population are known to exhibit floor effects in this population, which can obscure meaningful gains.

    Raw scores will be analyzed as continuous variables. The investigators will report change scores (follow-up minus baseline), individual trajectories, and summary statistics (mean, SD). Where appropriate, linear mixed-effects models or other growth modeling approaches will be used to account for within-subject variability.

    Higher scores on the MSEL indicate greater developmental progress. Raw scores on the Receptive Language domain range from 0 - 48.

  5. Change in Raw Scores on Fine Motor domain of the MSEL

    Time frame: Baseline and 18 months post diagnosis

    This outcome will assess individual-level change in raw scores on the Mullen Scales of Early Learning (MSEL), Fine Motor domain. Raw scores will be used instead of standard scores to detect meaningful change within-subject change. Standard scores in this population are known to exhibit floor effects in this population, which can obscure meaningful gains.

    Raw scores will be analyzed as continuous variables. The investigators will report change scores (follow-up minus baseline), individual trajectories, and summary statistics (mean, SD). Where appropriate, linear mixed-effects models or other growth modeling approaches will be used to account for within-subject variability.

    Higher scores on the MSEL indicate greater developmental progress. Raw scores on the Visual Reception domain range from 0 - 49.

  6. Change in Raw Scores on ABAS-3 Conceptual, Social and Practical Domains

    Time frame: Baseline and 18 months post diagnosis

    This outcome will assess change in raw scores for each of the three adaptive domains (Conceptual, Social and Practical) from the Adaptive Behavior Assessment System, Third Edition (ABAS-3). Raw scores offer greater sensitivity for detecting within-subject developmental changes over time. Each domain will be analyzed separately as a continuous variable. Where applicable, domain raw scores will also be summed to provide an exploratory composite.

    Higher scores indicate greater adaptive skill development.

    Conceptual domain raw score range: 0-222 Social domain raw score range: 0 - 144 Practical domain raw score range: 0-279

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly E Caravella, PhD

CONTACT

[email protected]

203-524-4349

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Foundation of Hope, North Carolina

Registry information

Official study title

Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study

Acronym: ROOTS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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