Clinical trial NCT05344378: Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism
Official title: Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Implementation Science
Mental Health
Behavioral Health
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: National Institute of Mental Health (NIMH)
First posted: 2022-04-25
Enrollment: 65
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for Primary Care Providers

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

Inclusion Criteria for Child/Caregiver Participants (Aim 3 only)

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.

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Distributed at study completion, an average of 1 year.
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Distributed at study completion, an average of 1 year.
measure: Appropriateness of Intervention Measure (AIM)
timeFrame: Distributed at study completion, an average of 1 year.
measure: the Navigation Satisfaction Tool (NAVSAT)
timeFrame: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
measure: Navigator Fidelity
timeFrame: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
measure: Eyberg Child Behavior Inventory (ECBI)
timeFrame: Measured at the start and completion of family navigation services for each family, approximately week 0 and 4 months after enrolling.
measure: Parent Activation Measure for Developmental Disabilities (PAM-DD)
timeFrame: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
measure: Parent Participation Engagement Measure
timeFrame: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD
state: California
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.