Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism

NCT ID: NCT05344378

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-08-30

Brief Summary

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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

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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).

Conditions

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Autism Spectrum Disorder Implementation Science Mental Health Behavioral Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1 Month Baseline Period

Initial baseline period for rollout at 6 different clinics throughout the year-long intervention period using a step-wedge design.

Group Type NO_INTERVENTION

No interventions assigned to this group

Stage 1 Enrollment

Enrollment of 2 clinics over 4 months including 5 PCPs per clinic (2 total clinics).

Group Type EXPERIMENTAL

ATTAIN NAV Technology-Enhanced Family Navigation Model

Intervention Type BEHAVIORAL

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.

Stage 2 Enrollment

Addition of 2 clinics with modifications over 4 months including 5 PCPs per clinic (4 total clinics).

Group Type EXPERIMENTAL

ATTAIN NAV Technology-Enhanced Family Navigation Model

Intervention Type BEHAVIORAL

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.

Stage 3 Enrollment

Addition of 2 clinics with modifications over 4 months including 5 PCPs per clinic (4 total clinics).

Group Type EXPERIMENTAL

ATTAIN NAV Technology-Enhanced Family Navigation Model

Intervention Type BEHAVIORAL

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.

Interventions

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ATTAIN NAV Technology-Enhanced Family Navigation Model

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Employed as staff at participating primary care practice
2. Experience providing primary care to children with ASD
3. For Aim 3 only: Has at least five eligible children on current caseload


1. Child age 4-16 years.
2. Child has a diagnosis of autism spectrum disorder documented in medical chart.
3. Child is receiving primary care at a participating primary care practice.
4. Child screens in the clinically significant range on the Pediatric Symptom Checklist at baseline.
5. Speaks English or Spanish.
6. Caregiver of an eligible child.
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Nicole Stadnick

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCSD

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31311287 (View on PubMed)

Stadnick 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.

Reference Type BACKGROUND
PMID: 35284636 (View on PubMed)

Stadnick 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.

Reference Type BACKGROUND
PMID: 32205263 (View on PubMed)

Stadnick 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.

Reference Type DERIVED
PMID: 40338511 (View on PubMed)

Other Identifiers

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1R34MH120190-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

200147

Identifier Type: -

Identifier Source: org_study_id

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