Autism Spectrum DisorderROOTSNCT07086781
Resources for Optimizing Outcomes in Toddlers on the Spectrum
A study testing Virtual Family Navigation and Educational Materials in people with Autism Spectrum Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Virtual Family Navigation and Educational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, 27510
Kelly Caravella, PhD, 2035244349, kelly_caravella@med.unc.edu
About this study
Official title: Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study
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:
Read more
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Virtual Family Navigation, Educational Materials
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Family NavigationBehavioural
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 MaterialsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Family Navigation | Experimental | 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. Receives: Behavioral: Virtual Family Navigation |
| Educational Materials | Active comparator | 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. Receives: Behavioral: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initiation of autism specific intervention
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).
Measured: Diagnosis to 18 months post
Secondary outcomes (6)
Caregiver Well-Being Score
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.
Measured: 6 months post diagnosis
Change in Raw Scores on Visual Reception domain of the MSEL
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.
Measured: Baseline and 18 months post diagnosis
Change in Raw Scores on Expressive Language domain of the MSEL
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.
Measured: Baseline and 18 months post diagnosis
Change in Raw Scores on Receptive Language domain of the MSEL
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.
Measured: Baseline and 18 months post diagnosis
Change in Raw Scores on Fine Motor domain of the MSEL
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.
Measured: Baseline and 18 months post diagnosis
Change in Raw Scores on ABAS-3 Conceptual, Social and Practical Domains
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
Measured: Baseline and 18 months post diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start19 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Responsible party
- Sponsor
- Investigators
- Kelly Caravella, PhD, Principal investigator, Carolina Institute for Developmental Disabilities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086781
- Sponsor's protocol ID
- 25-1164
- Acronym
- ROOTS
- Status last verified
- Oct 2025
- First submitted
- 18 Jul 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study
- ClinicalTrials.gov ID
- NCT07086781
- Acronym / sponsor ID
- ROOTS / 25-1164
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Study start
- 19 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Navigation | Experimental | Behavioral: Virtual Family NavigationParticipants 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 | Active comparator | Behavioral: Educational MaterialsThe 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. |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Family NavigationParticipants 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. | Behavioural | Family Navigation |
| Educational MaterialsThe 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. | Behavioural | Educational Materials |
Primary outcome
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).
6 secondary outcomes
Caregiver Well-Being Score
Time frame: 6 months post diagnosis
Change in Raw Scores on Visual Reception domain of the MSEL
Time frame: Baseline and 18 months post diagnosis
Change in Raw Scores on Expressive Language domain of the MSEL
Time frame: Baseline and 18 months post diagnosis
Change in Raw Scores on Receptive Language domain of the MSEL
Time frame: Baseline and 18 months post diagnosis
Change in Raw Scores on Fine Motor domain of the MSEL
Time frame: Baseline and 18 months post diagnosis
Change in Raw Scores on ABAS-3 Conceptual, Social and Practical Domains
Time frame: Baseline and 18 months post diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Caravella, PhD principal investigator
Carolina Institute for Developmental Disabilities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Family Navigation and Educational Materials in people with Autism Spectrum Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly E Caravella, PhD (203-524-4349, kelly_caravella@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to initiation of autism specific intervention (time frame: Diagnosis to 18 months post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.