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Completed

NCT Number: NCT05344378

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

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.

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Key information

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD

San Diego, California, 92093, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for Primary Care Providers

  • 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.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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:

    • 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Kaiser Permanente
  • National Institute of Mental Health (NIMH)

Registry information

Acronym: ATTAIN NAV

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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