Autism Spectrum DisorderATTAIN NAVNCT05344378
Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism
A study testing ATTAIN NAV Technology-Enhanced Family Navigation Model in people with Autism Spectrum Disorder and Implementation Science, run by University of California, San Diego at 1 site in United States.
Trial summary
This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental… Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Implementation Science, Mental Health
- What is being tested?
- ATTAIN NAV Technology-Enhanced Family Navigation Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 30 Aug 2024
- 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 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Employed as staff at participating primary care practice
- Experience providing primary care to children with ASD
- For Aim 3 only: Has at least five eligible children on current caseload
- Inclusion Criteria for Child/Caregiver Participants (Aim 3 only)
- Child age 4-16 years.
- Child has a diagnosis of autism spectrum disorder documented in medical chart.
Show all 10Show fewer
- Child is receiving primary care at a participating primary care practice.
- Child screens in the clinically significant range on the Pediatric Symptom Checklist at baseline.
- Speaks English or Spanish.
- Caregiver of an eligible child.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.
Read the detailed description
Efficient and effective access to and engagement with evidence-based mental health (MH) services for children with autism spectrum disorder (ASD) is critically needed but requires a tailored approach. This project is critical in establishing integrated and sustainable local capacity to provide evidence-based MH care for children (ages 4-16 years) with ASD+ (i.e., children with ASD and co-occurring psychiatric disorders). Specifically, the overarching goal of this mixed methods proposal is to collaboratively adapt Family Navigation (FN) content, navigator activities and training for children with ASD+, identify and design technology enhancements to FN that will target key mechanisms to impact implementation, service and clinical outcomes, key interrelated outcomes for implementation research. The research team will leverage existing partnerships with primary care practices and lay health worker organizations in San Diego County to establish a community-academic partnership that will guide adaptations to FN for children with ASD+ (Aim 1), co-design of the navigator-facing technology enhancements (Aim 2) and trial the adapted and technology-enhanced FN (Aim 3).
- Being tested
- ATTAIN NAV Technology-Enhanced Family Navigation Model
- Medical subject headings
- Autism Spectrum Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTAIN NAV Technology-Enhanced Family Navigation ModelBehavioural
The purpose of ATTAIN NAV is to test the impact of family navigation in multiple primary care clinics in Southern California for children with autism who have additional mental health needs. Family navigation includes: screening and behavioral health referral, supporting access to behavioral health services, engaging in evidence-based treatment, monitoring to achieve family goals, family strengthening, and connecting to concrete resources.
| Study group | Role | What they receive |
|---|---|---|
| 1 Month Baseline Period | No intervention | Initial baseline period for rollout at 6 different clinics throughout the year-long intervention period using a step-wedge design. |
| Stage 1 Enrollment | Experimental | Enrollment of 2 clinics over 4 months including 5 PCPs per clinic (2 total clinics). Receives: Behavioral: ATTAIN NAV Technology-Enhanced Family Navigation Model |
| Stage 2 Enrollment | Experimental | Addition of 2 clinics with modifications over 4 months including 5 PCPs per clinic (4 total clinics). Receives: Behavioral: ATTAIN NAV Technology-Enhanced Family Navigation Model |
| Stage 3 Enrollment | Experimental | Addition of 2 clinics with modifications over 4 months including 5 PCPs per clinic (4 total clinics). Receives: Behavioral: ATTAIN NAV Technology-Enhanced Family Navigation Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
Eyberg Child Behavior Inventory (ECBI)
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:
- 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.
- 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.
Measured: Measured at the start (~Week 0) and completion (~Month 4) of family navigation services for each dyad.
Parent Activation Measure for Developmental Disabilities (PAM-DD)
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.
Measured: Measure was completed by caregivers at baseline and post.
Parent Participation Engagement Measure (PPEM)
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.
Measured: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
Parent Participant Engagement: Number of Contacts
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.
Measured: Contacts measured per dyad from referral to family navigation services (Baseline) to conclusion of study participation. (Approximately 4 months).
Navigator Fidelity
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 May 2022
- Primary completion30 Jul 2024
- Study completion30 Aug 2024
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.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The investigators used a stepped wedge cluster randomized hybrid Type I effectiveness-implementation design to test the effects of technology-enhanced FN on service and clinical outcomes while gathering information on FN implementation (feasibility and acceptability). This design will also facilitate the early identification of technology enhancements that may require redesign to allow for testing of the redesigned enhancements during the subsequent step.
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nicole Stadnick, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344378
- Sponsor's protocol ID
- 200147
- Other IDs
- 1R34MH120190-01A1
- Acronym
- ATTAIN NAV
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2022
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Broder-Fingert S, Stadnick NA, Hickey E, Goupil J, Diaz Lindhart Y, Feinberg E. Defining the core components of Family Navigation for autism spectrum disorder. Autism. 2020 Feb;24(2):526-530. doi: 10.1177/1362361319864079. Epub 2019 Jul 16.
PubMed 31311287Stadnick NA, Penalosa MG, Martinez K, Brookman-Frazee L, Gizzo DP, Sahms T, Kuelbs CL, Aarons GA. Pre-Implementation Organizational Environment Associated with Pediatric Integrated Care Readiness in Primary Care. Evid Based Pract Child Adolesc Ment Health. 2022;7(1):5-11. doi: 10.1080/23794925.2021.1875344. Epub 2021 Feb 5.
PubMed 35284636Stadnick NA, Martinez K, Aarons GA, Lee DA, Van Cleave J, Brookman-Frazee L. Pediatric Primary Care Perspectives on Integrated Mental Health Care for Autism. Acad Pediatr. 2020 Nov-Dec;20(8):1140-1147. doi: 10.1016/j.acap.2020.03.006. Epub 2020 Mar 20.
PubMed 32205263Stadnick NA, Martinez K, Navarro F, Gomez-Patino P, Holmquist K, Negriff S, Roesch S, Bouchard I, Walpole S, Espinosa R, Broder-Fingert S, Barnett M, Brookman-Frazee L. Mixed Methods Findings from a Stepped Wedge Hybrid Implementation Trial of ATTAIN NAV: A Mental Health Family Navigation Intervention for Autistic Youth. J Autism Dev Disord. 2025 May 8. doi: 10.1007/s10803-025-06851-7. Online ahead of print.
PubMed 40338511
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism
- ClinicalTrials.gov ID
- NCT05344378
- Acronym / sponsor ID
- ATTAIN NAV / 200147
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Kaiser Permanente, National Institute of Mental Health (NIMH)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.
Detailed description
Efficient and effective access to and engagement with evidence-based mental health (MH) services for children with autism spectrum disorder (ASD) is critically needed but requires a tailored approach. This project is critical in establishing integrated and sustainable local capacity to provide evidence-based MH care for children (ages 4-16 years) with ASD+ (i.e., children with ASD and co-occurring psychiatric disorders). Specifically, the overarching goal of this mixed methods proposal is to collaboratively adapt Family Navigation (FN) content, navigator activities and training for children with ASD+, identify and design technology enhancements to FN that will target key mechanisms to impact implementation, service and clinical outcomes, key interrelated outcomes for implementation research. The research team will leverage existing partnerships with primary care practices and lay health worker organizations in San Diego County to establish a community-academic partnership that will guide adaptations to FN for children with ASD+ (Aim 1), co-design of the navigator-facing technology enhancements (Aim 2) and trial the adapted and technology-enhanced FN (Aim 3).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The investigators used a stepped wedge cluster randomized hybrid Type I effectiveness-implementation design to test the effects of technology-enhanced FN on service and clinical outcomes while gathering information on FN implementation (feasibility and acceptability). This design will also facilitate the early identification of technology enhancements that may require redesign to allow for testing of the redesigned enhancements during the subsequent step.
| Arm | Type | Receives |
|---|---|---|
| 1 Month Baseline Period | No intervention | –Initial baseline period for rollout at 6 different clinics throughout the year-long intervention period using a step-wedge design. |
| Stage 1 Enrollment | Experimental | Behavioral: ATTAIN NAV Technology-Enhanced Family Navigation ModelEnrollment of 2 clinics over 4 months including 5 PCPs per clinic (2 total clinics). |
| Stage 2 Enrollment | Experimental | Behavioral: ATTAIN NAV Technology-Enhanced Family Navigation ModelAddition of 2 clinics with modifications over 4 months including 5 PCPs per clinic (4 total clinics). |
| Stage 3 Enrollment | Experimental | Behavioral: ATTAIN NAV Technology-Enhanced Family Navigation ModelAddition of 2 clinics with modifications over 4 months including 5 PCPs per clinic (4 total clinics). |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Employed as staff at participating primary care practice
- Experience providing primary care to children with ASD
- For Aim 3 only: Has at least five eligible children on current caseload
- Inclusion Criteria for Child/Caregiver Participants (Aim 3 only)
- Child age 4-16 years.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ATTAIN NAV Technology-Enhanced Family Navigation ModelThe purpose of ATTAIN NAV is to test the impact of family navigation in multiple primary care clinics in Southern California for children with autism who have additional mental health needs. Family navigation includes: screening and behavioral health referral, supporting access to behavioral health services, engaging in evidence-based treatment, monitoring to achieve family goals, family strengthening, and connecting to concrete resources. | Behavioural | Stage 1 Enrollment, Stage 2 Enrollment, Stage 3 Enrollment |
Primary outcome
the Navigation Satisfaction Tool (NAVSAT)
Time frame: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
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.
Eyberg Child Behavior Inventory (ECBI)
Time frame: Measured at the start (~Week 0) and completion (~Month 4) of family navigation services for each dyad.
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.
Parent Activation Measure for Developmental Disabilities (PAM-DD)
Time frame: Measure was completed by caregivers at baseline and post.
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.
Parent Participation Engagement Measure (PPEM)
Time frame: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
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.
Parent Participant Engagement: Number of Contacts
Time frame: 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.
Navigator Fidelity
Time frame: 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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31311287Broder-Fingert S, Stadnick NA, Hickey E, Goupil J, Diaz Lindhart Y, Feinberg E. Defining the core components of Family Navigation for autism spectrum disorder. Autism. 2020 Feb;24(2):526-530. doi: 10.1177/1362361319864079. Epub 2019 Jul 16.
- Background: PubMed 35284636Stadnick NA, Penalosa MG, Martinez K, Brookman-Frazee L, Gizzo DP, Sahms T, Kuelbs CL, Aarons GA. Pre-Implementation Organizational Environment Associated with Pediatric Integrated Care Readiness in Primary Care. Evid Based Pract Child Adolesc Ment Health. 2022;7(1):5-11. doi: 10.1080/23794925.2021.1875344. Epub 2021 Feb 5.
- Background: PubMed 32205263Stadnick NA, Martinez K, Aarons GA, Lee DA, Van Cleave J, Brookman-Frazee L. Pediatric Primary Care Perspectives on Integrated Mental Health Care for Autism. Acad Pediatr. 2020 Nov-Dec;20(8):1140-1147. doi: 10.1016/j.acap.2020.03.006. Epub 2020 Mar 20.
- Results publication: PubMed 40338511Stadnick NA, Martinez K, Navarro F, Gomez-Patino P, Holmquist K, Negriff S, Roesch S, Bouchard I, Walpole S, Espinosa R, Broder-Fingert S, Barnett M, Brookman-Frazee L. Mixed Methods Findings from a Stepped Wedge Hybrid Implementation Trial of ATTAIN NAV: A Mental Health Family Navigation Intervention for Autistic Youth. J Autism Dev Disord. 2025 May 8. doi: 10.1007/s10803-025-06851-7. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATTAIN NAV Technology-Enhanced Family Navigation Model in people with Autism Spectrum Disorder and Implementation Science, run by University of California, San Diego 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 10 inclusion and 0 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: finished, as of the sponsor's last update on 8 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 8 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?
the Navigation Satisfaction Tool (NAVSAT) (time frame: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05344378, which also lists 4 linked publications.
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 8 Jul 2026.