Autism Spectrum DisorderEASENCT06291246
Expediting Access to Services for Equity
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 Black toddlers under the age of 4 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
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2024to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, or who are waiting for a diagnosis of autism AND their caregiver.
- Live in Georgia or North Carolina
- Caregiver must be over the age of 18
- Their child with autism must identify as Black/African-American
- 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.
United States1 site
Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, 27510
About this study
Official title: Expediting Enrollment Into Autism-specific Intervention for Black Toddlers: A Telehealth-based Family Navigation Approach
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 Black toddlers under the age of 4 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 Black 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 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. 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 2) of autism-specific intervention will be the date that families report the first session with a therapist following the diagnosis (date 1). Time will be calculated as the number of days elapsed between these two dates (date 2 - date 1).
Measured: From enrollment up to 6 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).
Measured: 6 months post enrollment
Child's Developmental Functioning Score
The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning. The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger performance.
Measured: 18 months post enrollment
Child's Adaptive Functioning Score
The Adaptive Behavior Assessment Scale, Third Edition (ABAS-3) will be used to measure adaptive functioning. The ABAS-3 assesses 3 domains of adaptive behavior, including Conceptual, Social, and Practical. The General Adaptive Composite (GAC) is a composite score derived from the 4 domains. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger adaptive behavior skills.
Measured: 18 months post enrollment
Appropriateness of Intervention Score
The Intervention Appropriateness Measure (IAM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's appropriateness. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness.
Measured: 6 months after enrollment
Feasibility of Intervention Score
The Feasibility of Intervention Measure (FIM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's feasibility. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness.
Measured: 6 months after enrollment
Acceptability of Intervention Score
The Acceptability of Intervention Measure (AIM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's acceptability. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness.
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start19 Nov 2024
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Why it stopped: Study was prematurely terminated by funder.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Kelly Caravella, PhD, Principal investigator, UNC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291246
- Sponsor's protocol ID
- 23-1823
- Other IDs
- K12TR004416-01
- Acronym
- EASE
- Status last verified
- Jul 2025
- First submitted
- 26 Feb 2024
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expediting Enrollment Into Autism-specific Intervention for Black Toddlers: A Telehealth-based Family Navigation Approach
- ClinicalTrials.gov ID
- NCT06291246
- Acronym / sponsor ID
- EASE / 23-1823
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was prematurely terminated by funder.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Posted 10 Jul 2026
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 Black toddlers under the age of 4 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 Black 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 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. |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Children up to 48 months who have a new diagnosis of autism, or who are waiting for a diagnosis of autism AND their caregiver.
- Live in Georgia or North Carolina
- Caregiver must be over the age of 18
- Their child with autism must identify as Black/African-American
- 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: From enrollment up to 6 months post
The date of initiation (date 2) of autism-specific intervention will be the date that families report the first session with a therapist following the diagnosis (date 1). 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 enrollment
Child's Developmental Functioning Score
Time frame: 18 months post enrollment
Child's Adaptive Functioning Score
Time frame: 18 months post enrollment
Appropriateness of Intervention Score
Time frame: 6 months after enrollment
Feasibility of Intervention Score
Time frame: 6 months after enrollment
Acceptability of Intervention Score
Time frame: 6 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Kelly Caravella, PhD principal investigator
UNC
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 5 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: stopped early, as of the sponsor's last update on 10 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Initiation of Autism Specific Intervention (time frame: From enrollment up to 6 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 10 Jul 2026.