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

NCT05344378 | Completed DMC

• 2 other identifiers: 2001471R34MH120190-01A1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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 health and community services for children with autism and their families.

Conditions

Mental Health; Autism Spectrum Disorder; Implementation Science; Behavioral Health

Outcome Measures

Primary Outcomes (8)

• Acceptability of Intervention Measure (AIM)

  4-item questionnaire measure adapted for the ATTAIN NAV study to assess acceptability of the overall adapted FN intervention. Four-item measures of implementation outcomes that are considered indicators of implementation success. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Higher scores indicate a better outcome.

  Distributed at study completion, an average of 1 year.

• Feasibility of Intervention Measure (FIM)

  4-item questionnaire measure adapted for the ATTAIN NAV study to assess feasibility of the overall adapted FN intervention. Four-item measures of implementation outcomes that are considered indicators of implementation success. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Higher scores indicate a better outcome.

  Distributed at study completion, an average of 1 year.

• Appropriateness of Intervention Measure (AIM)

  4-item questionnaire measure adapted for the ATTAIN NAV study to assess appropriateness of the overall adapted FN intervention. Four-item measures of implementation outcomes that are considered indicators of implementation success. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Higher scores indicate a better outcome.

  Distributed at study completion, an average of 1 year.

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

• Navigator Fidelity

  The investigators will adapt fidelity procedures (observational and self-report) from the navigator training curriculum used in MOST. Fidelity will be defined as demonstrating mastery on at least 80% of all components (e.g., navigator introduces purpose of navigation during initial contact, conducts assessment on barriers to attendance of first MH appointment). Fidelity will be measured at the completion of the navigator protocol for each family.

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

• Eyberg Child Behavior Inventory (ECBI)

  The ECBI is a 36-item caregiver-report measure that assesses the frequency and intensity of child behavior problems. It has shown sensitivity to change over time. There are two scores: an Intensity score (frequency of behaviors) and a Problem (number of challenging behaviors) score. Both are converted into t-scores (M =50; SD=10). Scoring: on a 1-7 scale: How often does this occur with your child? ranging from (1) Never to (7) Always. There is a secondary scale that asks is this a problem for you? Yes/No.

  Measured at the start and completion of family navigation services for each family, approximately week 0 and 4 months after enrolling.

• Parent Activation Measure for Developmental Disabilities (PAM-DD)

  This 13-item measure will be used to examine changes in caregiver knowledge, skill and confidence to manage their child. The PAM-DD also includes a rating scale of perceived caregiver activation level. The scale ranges from (1) strongly disagree to (4) strongly agree. A higher score indicates a more positive rating.

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

• Parent Participation Engagement Measure

  A 5-item parent-report measure of active caregiver engagement in youth mental health services. 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 on a 5-point scale ranging from (1) Not at all to (5) very much. To additionally capture family engagement, the investigators will track the number of contacts between the navigator and family during the interval between the PCP referral to navigation and the first completed MH appointment.

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

Study Arms (4)

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).

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).

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).

Behavioral: ATTAIN NAV Technology-Enhanced Family Navigation Model

Interventions

ATTAIN NAV Technology-Enhanced Family Navigation Model 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 1 Enrollment; Stage 2 Enrollment; Stage 3 Enrollment

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Child age 4-16 years.
• Child has a diagnosis of autism spectrum disorder documented in medical chart.
• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of California, San Diego: lead
• Kaiser Permanente: collaborator

Study Sites (1)

UCSD

San Diego, California, 92093, United States

Location

Related Publications (4)

• 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.

  PMID: 31311287 BACKGROUND

• 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.

  PMID: 35284636 BACKGROUND

• 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.

  PMID: 32205263 BACKGROUND

• 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.

  PMID: 40338511 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 25, 2022
• Study Start: May 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)