Trial Outcomes & Findings for Expediting Access to Services for Equity (NCT NCT06291246)
NCT ID: NCT06291246
Last Updated: 2026-07-10
Results Overview
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).
TERMINATED
NA
33 participants
From enrollment up to 6 months post
2026-07-10
Participant Flow
Of the 33 participants (16 Family Units \[FU\]) who met initial eligibility and signed informed consent, 31 participants (15 FUs) completed Baseline and remained eligible for randomization. Of those eligible, 6 participants (3 FUs) did not continue following randomization and did not receive any exposure to a study intervention. Data are reported below for the 25 participants (12 FUs) exposed to a study intervention.
Participant milestones
| Measure |
Family Navigation
Family Units 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.
Virtual Family Navigation: Family Unit Caregivers 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
The comparison condition ("Educational Materials") consists of providing the Family Unit Caregiver information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Family Units in this condition will receive this information throughout 4 timepoints in the first 3 months after randomization.
Educational Materials: The comparison condition ("Educational Materials") consists of providing the Family Unit 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.
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|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
Caregivers
|
7
|
6
|
|
Overall Study
Children
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
| Measure |
Family Navigation
Family Units 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.
Virtual Family Navigation: Family Unit Caregivers 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
The comparison condition ("Educational Materials") consists of providing the Family Unit Caregiver information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Family Units in this condition will receive this information throughout 4 timepoints in the first 3 months after randomization.
Educational Materials: The comparison condition ("Educational Materials") consists of providing the Family Unit 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.
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|---|---|---|
|
Overall Study
Study terminated
|
13
|
12
|
Baseline Characteristics
Data are reported separately for Caregivers and Children.
Baseline characteristics by cohort
| Measure |
Family Navigation
n=13 Participants
Family Units 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.
Virtual Family Navigation: Family Unit Caregivers 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
n=12 Participants
The comparison condition ("Educational Materials") consists of providing the Family Unit Caregiver information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Family Units in this condition will receive this information throughout 4 timepoints in the first 3 months after randomization.
Educational Materials: The comparison condition ("Educational Materials") consists of providing the Family Unit 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.
|
Total
n=25 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Categorical
Caregivers · <=18 years
|
0 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Age, Categorical
Caregivers · Between 18 and 65 years
|
7 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
6 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
13 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Age, Categorical
Caregivers · >=65 years
|
0 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Age, Categorical
Children · <=18 years
|
6 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
6 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
12 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Age, Categorical
Children · Between 18 and 65 years
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Age, Categorical
Children · >=65 years
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Sex: Female, Male
Caregivers · Female
|
6 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
6 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
12 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Sex: Female, Male
Caregivers · Male
|
1 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
1 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Sex: Female, Male
Children · Female
|
4 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
4 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
8 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Sex: Female, Male
Children · Male
|
2 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
2 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
4 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
0 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
7 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
6 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
13 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Ethnicity (NIH/OMB)
Children · Hispanic or Latino
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Ethnicity (NIH/OMB)
Children · Not Hispanic or Latino
|
6 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
6 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
12 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Ethnicity (NIH/OMB)
Children · Unknown or Not Reported
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Caregivers · Asian
|
0 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
7 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
6 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
13 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Caregivers · White
|
0 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
0 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=7 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=13 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Children · American Indian or Alaska Native
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Children · Asian
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Children · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Children · Black or African American
|
6 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
5 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
11 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Children · White
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Children · More than one race
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
1 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
1 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Race (NIH/OMB)
Children · Unknown or Not Reported
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=6 Participants • Data are reported separately for Caregivers and Children.
|
0 Participants
n=12 Participants • Data are reported separately for Caregivers and Children.
|
|
Region of Enrollment
United States · Caregivers
|
7 Participants
n=13 Participants
|
6 Participants
n=12 Participants
|
13 Participants
n=25 Participants
|
|
Region of Enrollment
United States · Children
|
6 Participants
n=13 Participants
|
6 Participants
n=12 Participants
|
12 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: From enrollment up to 6 months postPopulation: Data are reported for 3 children in Family Navigation and 2 children in Educational Materials who had initiated community-based services at the time the study was terminated. Therefore, these data are right-censored at 180 days.
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).
Outcome measures
| Measure |
Family Navigation
n=3 Participants
Family Units 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
n=2 Participants
Family Units randomized to the Educational Materials condition will receive up to 4 information packets throughout 4 timepoints in the first 3 months after randomization. This packets include information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations.
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|---|---|---|
|
Time to Initiation of Autism Specific Intervention
|
103 days
Interval 24.0 to 156.0
|
71 days
Interval 21.0 to 120.0
|
SECONDARY outcome
Timeframe: 6 months post enrollmentPopulation: Data are reported for the 2 caregivers in each condition who provided data by the time the study was terminated.
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).
Outcome measures
| Measure |
Family Navigation
n=2 Participants
Family Units 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
n=2 Participants
Family Units randomized to the Educational Materials condition will receive up to 4 information packets throughout 4 timepoints in the first 3 months after randomization. This packets include information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations.
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|---|---|---|
|
Caregiver Well-Being Score
|
62.5 score on a scale
Interval 42.0 to 83.0
|
72 score on a scale
Interval 65.0 to 79.0
|
SECONDARY outcome
Timeframe: 18 months post enrollmentPopulation: No participants made it to this timepoint in the study, due to premature study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 months post enrollmentPopulation: No participants made it to this timepoint in the study, due to premature study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after enrollmentPopulation: This outcome was intended to be collected once at approximately 6 months post enrollment during facilitated live interviews with research staff. Unlike other Month 6 outcomes collected via emailed surveys, this assessment required a live interview visit. Study termination occurred before the interview protocol was finalized and any scheduled live interview visits were cancelled. As a result, no participants completed this assessment and no data were collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after enrollmentPopulation: This outcome was intended to be collected once at approximately 6 months post enrollment during facilitated live interviews with research staff. Unlike other Month 6 outcomes collected via emailed surveys, this assessment required a live interview visit. Study termination occurred before the interview protocol was finalized and any scheduled live interview visits were cancelled. As a result, no participants completed this assessment and no data were collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after enrollmentPopulation: This outcome was intended to be collected once at approximately 6 months post enrollment during facilitated live interviews with research staff. Unlike other Month 6 outcomes collected via emailed surveys, this assessment required a live interview visit. Study termination occurred before the interview protocol was finalized and any scheduled live interview visits were cancelled. As a result, no participants completed this assessment and no data were collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
Family Navigation Caregivers
Family Navigation Children
Educational Materials Caregivers
Educational Materials Children
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kelly Caravella, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place