Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engag… (NCT05344378) | Clinical Trial Compass
CompletedNot Applicable
Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism
United States151 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range
4 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the Navigation Satisfaction Tool (NAVSAT)
Timeframe: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
2
Eyberg Child Behavior Inventory (ECBI)
Timeframe: Measured at the start (~Week 0) and completion (~Month 4) of family navigation services for each dyad.
3
Parent Activation Measure for Developmental Disabilities (PAM-DD)
Timeframe: Measure was completed by caregivers at baseline and post.
4
Parent Participation Engagement Measure (PPEM)
Timeframe: Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
5
Parent Participant Engagement: Number of Contacts
Timeframe: Contacts measured per dyad from referral to family navigation services (Baseline) to conclusion of study participation. (Approximately 4 months).
6
Navigator Fidelity
Timeframe: 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).