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).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

From enrollment up to 6 months post

Results posted on

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

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.
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

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.
Overall Study
Study terminated
13
12

Baseline Characteristics

Data are reported separately for Caregivers and Children.

Baseline characteristics by cohort

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
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 post

Population: 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

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.
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 enrollment

Population: 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

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.
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 enrollment

Population: 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 enrollment

Population: 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 enrollment

Population: 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 enrollment

Population: 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 enrollment

Population: 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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Family Navigation Children

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Educational Materials Caregivers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Educational Materials Children

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 919-891-2613

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place