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

NCT05344378 | Completed Results DMC

• 2 other identifiers: 2001471R34MH120190-01A1
• Study Type: interventional
• Target: 151
• 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 (6)

• 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.

• 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: 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.

  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.

  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 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.

  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.

  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).

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 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Nicole Stadnick, PhD, MPH
• Organization: University of California, San Diego

nstadnic@health.ucsd.edu

858-249-0342

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Associate 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: July 8, 2026
• Results First Posted: July 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)