Trial Outcomes & Findings for Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism (NCT NCT05344378)

NCT ID: NCT05344378

Last Updated: 2026-07-08

Results Overview

22 item questionnaire assess satisfaction with the relationship with the navigator and with the referred services to which the navigator facilitated access. Response scale: 1= Extremely Dissatisfied 2=Dissatisfied 3=Fairly Dissatisfied 4= Not dissatisfied nor satisfied 5= Fairly Satisfied 6= Satisfied 7= Extremely Satisfied. Higher scores indicate a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

151 participants

Primary outcome timeframe

Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.

Results posted on

2026-07-08

Participant Flow

Mixed method, modified cluster randomized stepped wedge hybrid type 1 effectiveness implementation trial design to test the effects of technology-enhanced vs standard FN on service and clinical outcomes while gathering information on FN implementation. Clinics (6) were assigned to a FN condition (2 every 3 months). Seq. 1 - 3) until all clinics were in a FN condition. 65 caregiver-child dyads were enrolled.

Clinics were enrolled across three sequences (2 clinics per sequence). 6 total clinics. 65 caregiver/adolescent dyads (65 caregivers, 65 adolescents) and 21 primary care providers were enrolled in the study. Total Individual Participants Enrolled: 151. 56 caregiver/adolescent dyads (56 caregivers, 56 adolescents), and 21 providers completed the study. Total Individual Participants Completed: 133.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure
Sequence 1: Standard Family Navigation
Clinics were randomized in three sequences, two clinics per sequence. In Sequence 1, one clinic was assigned to standard family navigation, and one clinic was assigned to technology enhanced family navigation. This arm reflects information for Sequence 1, Clinic 1 (Standard Family Navigation). This clinic had one month of observation followed by 22 months of standard family navigation. 9 caregiver/adolescent dyads from this clinic were enrolled, and 6 caregiver/adolescent dyads completed the study. 5 providers from this clinic were enrolled in the study, and 5 providers completed the study.
Sequence 1: Technology Enhanced Family Navigation
Clinics were randomized in three sequences, two clinics per sequence. In Sequence 1, one clinic was assigned to standard family navigation, and one clinic was assigned to technology enhanced family navigation. This arm reflects information for Sequence 1, Clinic 2 (Technology Enhanced Family Navigation). This clinic had two months of observation followed by 21 months of Technology-Enhanced Family Navigation. 15 caregiver/adolescent dyads from this clinic were enrolled, and 14 caregiver/adolescent dyads completed the study. 4 providers from this clinic were enrolled in the study, and 4 providers completed the study.
Sequence 2: Standard Family Navigation
Clinics were randomized in three sequences, two clinics per sequence. In Sequence 2, one clinic was assigned to standard family navigation, and one clinic was assigned to technology enhanced family navigation. This arm reflects information for Sequence 2, Clinic 1 (Standard Family Navigation). This clinic had nine months of observation followed by 14 months of standard family navigation. 8 caregiver/adolescent dyads from this clinic were enrolled, and 6 caregiver/adolescent dyads completed the study. 4 providers from this clinic were enrolled in the study, and 4 providers completed the study.
Sequence 2: Technology-Enhanced Family Navigation
Clinics were randomized in three sequences, two clinics per sequence. In Sequence 2, one clinic was assigned to standard family navigation, and one clinic was assigned to technology enhanced family navigation. This arm reflects information for Sequence 2, Clinic 2 (Technology-Enhanced Family Navigation). This clinic had four months of observation followed by 19 months of Technology-Enhanced Family Navigation. 12 caregiver/adolescent dyads from this clinic were enrolled, and 11 caregiver/adolescent dyads completed the study. 3 providers from this clinic were enrolled in the study, and 3 providers completed the study.
Sequence 3: Standard Family Navigation
Clinics were randomized in three sequences, two clinics per sequence. In Sequence 3, one clinic was assigned to standard family navigation, and one clinic was assigned to technology enhanced family navigation. This arm reflects information for Sequence 3, Clinic 1 (Standard Family Navigation). This clinic had 11 months of observation followed by 12 months of Standard Family Navigation. 12 caregiver/adolescent dyads from this clinic were enrolled, and 10 caregiver/adolescent dyads completed the study. 2 providers from this clinic were enrolled in the study, and 2 providers completed the study.
Sequence 3: Technology-Enhanced Family Navigation
Clinics were randomized in three sequences, two clinics per sequence. In Sequence 3, one clinic was assigned to standard family navigation, and one clinic was assigned to technology enhanced family navigation. This arm reflects information for Sequence 3, Clinic 2 (Technology-Enhanced Family Navigation). This clinic had 12 months of observation followed by 11 months of Technology-Enhanced Family Navigation. 9 caregiver/adolescent dyads from this clinic were enrolled, and 9 caregiver/adolescent dyads completed the study. 3 providers from this clinic were enrolled in the study, and 3 providers completed the study.
Overall Study
STARTED
23 1
34 1
20 1
27 1
26 1
21 1
Overall Study
Provider Participants: Started
5 1
4 1
4 1
3 1
2 1
3 1
Overall Study
Caregiver Participants: Started
9 1
15 1
8 1
12 1
12 1
9 1
Overall Study
Child Participants: Started
9 1
15 1
8 1
12 1
12 1
9 1
Overall Study
Provider Participants: Completed
5 1
4 1
4 1
3 1
2 1
3 1
Overall Study
Caregiver Participants: Completed
6 1
14 1
6 1
11 1
10 1
9 1
Overall Study
Child Participants: Completed
6 1
14 1
6 1
11 1
10 1
9 1
Overall Study
COMPLETED
17 1
32 1
16 1
25 1
22 1
21 1
Overall Study
NOT COMPLETED
6 0
2 0
4 0
2 0
4 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participant Age (Years). Reported as condition x participant type. Data from the 56 caregiver/child dyads that completed the study analyzed. Data from 21 providers analyzed. Total: 133 individual participants (56 children, 56 caregivers, 21 providers).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard Family Navigation: Child Participants
n=22 Participants
Baseline data for child participants enrolled in standard family navigation clinics (3 clinics total).
Technology-Enhanced Family Navigation: Child Participants
n=34 Participants
Baseline data for child participants enrolled in technology-enhanced family navigation clinics (3 clinics total).
Standard Family Navigation: Caregiver Participants
n=22 Participants
Baseline data for caregiver participants enrolled in standard family navigation clinics (3 clinics total).
Technology-Enhanced Family Navigation: Caregiver Participants
n=34 Participants
Baseline data for caregiver participants enrolled in family navigation clinics (3 clinics total).
Standard Family Navigation: Provider Participants
n=11 Participants
Baseline data for provider participants enrolled in standard family navigation clinics (3 clinics total).
Technology-Enhanced Family Navigation: Provider Participants
n=10 Participants
Baseline data for provider participants enrolled in technology-enhanced family navigation clinics (3 clinics total).
Total
n=133 Participants
Total of all reporting groups
Sex: Female, Male
Male
17 Participants
n=9 Participants
29 Participants
n=27 Participants
3 Participants
n=267 Participants
4 Participants
n=265 Participants
4 Participants
n=568 Participants
2 Participants
n=22 Participants
59 Participants
n=23 Participants
Age, Continuous
7.50 Age (Years)
STANDARD_DEVIATION 2.50 • n=9 Participants • Participant Age (Years). Reported as condition x participant type. Data from the 56 caregiver/child dyads that completed the study analyzed. Data from 21 providers analyzed. Total: 133 individual participants (56 children, 56 caregivers, 21 providers).
7.68 Age (Years)
STANDARD_DEVIATION 2.91 • n=27 Participants • Participant Age (Years). Reported as condition x participant type. Data from the 56 caregiver/child dyads that completed the study analyzed. Data from 21 providers analyzed. Total: 133 individual participants (56 children, 56 caregivers, 21 providers).
41.4 Age (Years)
STANDARD_DEVIATION 6.34 • n=267 Participants • Participant Age (Years). Reported as condition x participant type. Data from the 56 caregiver/child dyads that completed the study analyzed. Data from 21 providers analyzed. Total: 133 individual participants (56 children, 56 caregivers, 21 providers).
44.7 Age (Years)
STANDARD_DEVIATION 5.26 • n=265 Participants • Participant Age (Years). Reported as condition x participant type. Data from the 56 caregiver/child dyads that completed the study analyzed. Data from 21 providers analyzed. Total: 133 individual participants (56 children, 56 caregivers, 21 providers).
46.7 Age (Years)
STANDARD_DEVIATION 8.75 • n=568 Participants • Participant Age (Years). Reported as condition x participant type. Data from the 56 caregiver/child dyads that completed the study analyzed. Data from 21 providers analyzed. Total: 133 individual participants (56 children, 56 caregivers, 21 providers).
51.3 Age (Years)
STANDARD_DEVIATION 5.97 • n=22 Participants • Participant Age (Years). Reported as condition x participant type. Data from the 56 caregiver/child dyads that completed the study analyzed. Data from 21 providers analyzed. Total: 133 individual participants (56 children, 56 caregivers, 21 providers).
27.1 Age (Years)
STANDARD_DEVIATION 17.3 • n=23 Participants • Participant Age (Years). Reported as condition x participant type. Data from the 56 caregiver/child dyads that completed the study analyzed. Data from 21 providers analyzed. Total: 133 individual participants (56 children, 56 caregivers, 21 providers).
Sex: Female, Male
Female
5 Participants
n=9 Participants
5 Participants
n=27 Participants
19 Participants
n=267 Participants
30 Participants
n=265 Participants
7 Participants
n=568 Participants
8 Participants
n=22 Participants
74 Participants
n=23 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
0 Participants
n=265 Participants
0 Participants
n=568 Participants
0 Participants
n=22 Participants
2 Participants
n=23 Participants
Race (NIH/OMB)
Asian
2 Participants
n=9 Participants
6 Participants
n=27 Participants
1 Participants
n=267 Participants
9 Participants
n=265 Participants
5 Participants
n=568 Participants
4 Participants
n=22 Participants
27 Participants
n=23 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=27 Participants
1 Participants
n=267 Participants
0 Participants
n=265 Participants
0 Participants
n=568 Participants
0 Participants
n=22 Participants
1 Participants
n=23 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=9 Participants
2 Participants
n=27 Participants
0 Participants
n=267 Participants
2 Participants
n=265 Participants
1 Participants
n=568 Participants
1 Participants
n=22 Participants
6 Participants
n=23 Participants
Race (NIH/OMB)
White
5 Participants
n=9 Participants
10 Participants
n=27 Participants
10 Participants
n=267 Participants
13 Participants
n=265 Participants
4 Participants
n=568 Participants
3 Participants
n=22 Participants
45 Participants
n=23 Participants
Race (NIH/OMB)
More than one race
5 Participants
n=9 Participants
6 Participants
n=27 Participants
2 Participants
n=267 Participants
2 Participants
n=265 Participants
1 Participants
n=568 Participants
1 Participants
n=22 Participants
17 Participants
n=23 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants
n=9 Participants
10 Participants
n=27 Participants
8 Participants
n=267 Participants
8 Participants
n=265 Participants
0 Participants
n=568 Participants
1 Participants
n=22 Participants
35 Participants
n=23 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
17 Participants
n=9 Participants
9 Participants
n=27 Participants
16 Participants
n=267 Participants
8 Participants
n=265 Participants
1 Participants
n=568 Participants
1 Participants
n=22 Participants
52 Participants
n=23 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=9 Participants
23 Participants
n=27 Participants
6 Participants
n=267 Participants
26 Participants
n=265 Participants
10 Participants
n=568 Participants
9 Participants
n=22 Participants
78 Participants
n=23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=9 Participants
2 Participants
n=27 Participants
0 Participants
n=267 Participants
0 Participants
n=265 Participants
0 Participants
n=568 Participants
0 Participants
n=22 Participants
3 Participants
n=23 Participants

PRIMARY outcome

Timeframe: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.

Population: Parent-reported satisfaction with family navigation using the Navigation Satisfaction Tool (NAVSAT).

22 item questionnaire assess satisfaction with the relationship with the navigator and with the referred services to which the navigator facilitated access. Response scale: 1= Extremely Dissatisfied 2=Dissatisfied 3=Fairly Dissatisfied 4= Not dissatisfied nor satisfied 5= Fairly Satisfied 6= Satisfied 7= Extremely Satisfied. Higher scores indicate a better outcome.

Outcome measures

Outcome measures
Measure
Technology-Enhanced Family Navigation (FN)
n=34 Participants
Technology-Enhanced Family Navigation. This condition included three components: a KP.org messaging (Patient-Facing) capabilities, Twilio/REDCap (Patient-Facing) messaging, and an enrollment dashboard (Provider-Facing).
Standard Family Navigation (FN)
n=22 Participants
Standard Family Navigation (FN). FN for this condition was delivered without the technology-enhanced components.
the Navigation Satisfaction Tool (NAVSAT)
6.17 Scores on a scale
Standard Deviation 0.93
6.52 Scores on a scale
Standard Deviation 0.76

PRIMARY outcome

Timeframe: Measured at the start (~Week 0) and completion (~Month 4) of family navigation services for each dyad.

Population: Baseline and Post: ECBI intensity scale raw score (Rows 1\&2) and ECBI problem scale raw score (Rows 3\&4) reported for child participants in the Standard FN condition and Tech Enhanced FN condition.

The ECBI 36-item caregiver-report measure that assesses parent perceptions of frequency/severity of problem behaviors in their children/adolescent. There are two scales: 1. Intensity Scale: Measures the frequency behaviors reportedly occur. Items query "How often does X problem occur with your child? Responses rated on Likert scale from "(1) Never" to "(7) Always." Scoring: Responses to all 36 questions were added to derive the Raw intensity score (min.= 36, max.= 252). Cut-off for clinical significance: \>/= 131. 2. Problem Scale: Secondary scale that measures degree to which behavior is problematic. Parents prompted to answer "Is this a problem for you?" with "(1) yes" or "(0) no." Scoring: Total "Yes" responses for the 36 items were added derive the Raw problem score (min.=0, max=36). Cut-off for clinical significance: \>\\= 15. Because scores are weighted, higher scores that exceed identified clinical cutoffs reflect greater concern about the child's behaviors.

Outcome measures

Outcome measures
Measure
Technology-Enhanced Family Navigation (FN)
n=34 Participants
Technology-Enhanced Family Navigation. This condition included three components: a KP.org messaging (Patient-Facing) capabilities, Twilio/REDCap (Patient-Facing) messaging, and an enrollment dashboard (Provider-Facing).
Standard Family Navigation (FN)
n=22 Participants
Standard Family Navigation (FN). FN for this condition was delivered without the technology-enhanced components.
Eyberg Child Behavior Inventory (ECBI)
ECBI Intensity - Baseline
135.79 scores on a scale
Standard Deviation 31.95
144.77 scores on a scale
Standard Deviation 21.96
Eyberg Child Behavior Inventory (ECBI)
ECBI Intensity - Post
134.39 scores on a scale
Standard Deviation 34.43
121.90 scores on a scale
Standard Deviation 28.62
Eyberg Child Behavior Inventory (ECBI)
ECBI Problem - Baseline
17.52 scores on a scale
Standard Deviation 7.80
18.57 scores on a scale
Standard Deviation 4.35
Eyberg Child Behavior Inventory (ECBI)
ECBI Problem - Post
15.71 scores on a scale
Standard Deviation 7.90
11.82 scores on a scale
Standard Deviation 8.09

PRIMARY outcome

Timeframe: Measure was completed by caregivers at baseline and post.

Population: Multiple rows used to provide scores for PMADD at baseline and post. Subscales 1 and 2 reported separately.

The Parent Activation Measures for Developmental Disabilities (PAM-DD) is 13-item measure used to examine changes in caregiver knowledge, skill and confidence to manage their child. The first subscale includes items related to the motivation and ability to actively intervene for one's child (e.g., ability to reduce problems, handle services, implement home treatments, understand behavior causes, use available treatments, implement recommendations, prevent problems, figure out solutions, and maintain changes). The second subscale contains items related to parental knowledge, cooperation, and agreement with treatment (e.g., responsibility for child's behavior, participation with treatment role). Respondents rate each item from (1) strongly disagree to (4) strongly agree. A higher score indicates a more positive rating (i.e., greater parent activation). Scores below reflect averages across items for each subscale (1 - 4) at baseline and post.

Outcome measures

Outcome measures
Measure
Technology-Enhanced Family Navigation (FN)
n=34 Participants
Technology-Enhanced Family Navigation. This condition included three components: a KP.org messaging (Patient-Facing) capabilities, Twilio/REDCap (Patient-Facing) messaging, and an enrollment dashboard (Provider-Facing).
Standard Family Navigation (FN)
n=22 Participants
Standard Family Navigation (FN). FN for this condition was delivered without the technology-enhanced components.
Parent Activation Measure for Developmental Disabilities (PAM-DD)
PMADD Subscale 1 Baseline
3.45 scores on a scale
Standard Deviation 0.48
3.49 scores on a scale
Standard Deviation 0.65
Parent Activation Measure for Developmental Disabilities (PAM-DD)
PMADD Subscale 1 Post
3.59 scores on a scale
Standard Deviation 0.44
3.83 scores on a scale
Standard Deviation 0.29
Parent Activation Measure for Developmental Disabilities (PAM-DD)
PMADD Subscale 2 Baseline
3.24 scores on a scale
Standard Deviation 0.49
3.19 scores on a scale
Standard Deviation 0.67
Parent Activation Measure for Developmental Disabilities (PAM-DD)
PMADD Subscale 2 Post
3.43 scores on a scale
Standard Deviation 0.57
3.66 scores on a scale
Standard Deviation 0.46

PRIMARY outcome

Timeframe: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.

Population: Parent engagement was assessed at post using the 5-item, caregiver-report, PPEM (Haine-Schlagel et al., 2016). A mean score was used in analyses.

The PPEM is a 5-item parent-report measure of active caregiver engagement in youth mental health services (Haine-Schlagel et al., 2016). Each item assesses the frequency that a parent engaged in a participation behavior (e.g., asked questions, provided input, agreed with the plan) during a MH appointment. Items are rated on a 5-point scale ranging from (1) Not at all to (5) very much.

Outcome measures

Outcome measures
Measure
Technology-Enhanced Family Navigation (FN)
n=34 Participants
Technology-Enhanced Family Navigation. This condition included three components: a KP.org messaging (Patient-Facing) capabilities, Twilio/REDCap (Patient-Facing) messaging, and an enrollment dashboard (Provider-Facing).
Standard Family Navigation (FN)
n=22 Participants
Standard Family Navigation (FN). FN for this condition was delivered without the technology-enhanced components.
Parent Participation Engagement Measure (PPEM)
4.23 scores on a scale
Standard Deviation 0.48
4.35 scores on a scale
Standard Deviation 0.65

PRIMARY outcome

Timeframe: Contacts measured per dyad from referral to family navigation services (Baseline) to conclusion of study participation. (Approximately 4 months).

To additionally capture family engagement, the number of contact attempts (e.g., navigation sessions, texts, voicemail messages) between the navigator and each family during the interval between PCP referral to ATTAIN NAV (wherein a dyad was enrolled in family navigation following observation period) and the conclusion of ATTAIN NAV (end of a dyad's study participation) was calculated. These data were abstracted from the family navigation contact logs and include unsuccessful attempts.

Outcome measures

Outcome measures
Measure
Technology-Enhanced Family Navigation (FN)
n=34 Participants
Technology-Enhanced Family Navigation. This condition included three components: a KP.org messaging (Patient-Facing) capabilities, Twilio/REDCap (Patient-Facing) messaging, and an enrollment dashboard (Provider-Facing).
Standard Family Navigation (FN)
n=22 Participants
Standard Family Navigation (FN). FN for this condition was delivered without the technology-enhanced components.
Parent Participant Engagement: Number of Contacts
29.78 Number of contacts
Standard Deviation 14.13
18.79 Number of contacts
Standard Deviation 5.80

PRIMARY outcome

Timeframe: Navigators provided fidelity ratings for dyads at three points: (1) First session (Baseline), (2) Follow-up session at midpoint of family navigation (Approx. Month 2), and (3) Final session (Approx. Month 4).

Population: Navigators were not considered participants in this research study. Scores for navigator fidelity were provided at 3 time points for each family/dyad. A mean fidelity rating across the three sessions was computed for each family. Data reported here reflects the average navigator fidelity for the two study conditions.

Navigator fidelity was assessed using fidelity procedures (observational and self-report) from the navigator training curriculum used in previous autism-specific family navigation studies (Broder-Fingert et al., 2019, 2020). Navigators provided self-report fidelity ratings at three time-points: the Family Plan Development session (first navigation session), a follow-up session at the midpoint of family navigation, and the final session. Range: 0% - 100% "Fidelity" was defined as demonstrating mastery on at least 80% of components (e.g., navigator introduces purpose of navigation during initial contact, conducts assessment of barriers to attendance of first mental health appointment). A mean fidelity rating across the three sessions was computed for each family at post. Overall average for both conditions is reported here.

Outcome measures

Outcome measures
Measure
Technology-Enhanced Family Navigation (FN)
n=34 Participants
Technology-Enhanced Family Navigation. This condition included three components: a KP.org messaging (Patient-Facing) capabilities, Twilio/REDCap (Patient-Facing) messaging, and an enrollment dashboard (Provider-Facing).
Standard Family Navigation (FN)
n=22 Participants
Standard Family Navigation (FN). FN for this condition was delivered without the technology-enhanced components.
Navigator Fidelity
93.39 Percent of fidelity components mastered
Standard Deviation 6.59
95.57 Percent of fidelity components mastered
Standard Deviation 5.31

Adverse Events

Standard Family Navigation (FN): Child Participants

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

Technology-Enhanced Family Navigation (FN): Child Participants

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

Control/No Intervention: Child Participants

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

Standard Family Navigation (FN): Parent Participants

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

Technology-Enhanced Family Navigation (FN): Parent Participants

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

Control/No Intervention: Parent Participants

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

Standard Family Navigation (FN): Provider Participants

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

Technology-Enhanced Family Navigation (FN): Provider Participants

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

Control/No Intervention: Provider Participants

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

Nicole Stadnick, PhD, MPH

University of California, San Diego

Phone: 858-249-0342

Results disclosure agreements

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