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Building Resilient Families
NCT05388864 · View on ClinicalTrials.gov ↗
Study Summary
Prior research suggests that it is possible to improve health outcomes in children with ACEs through multi-component interventions. The challenge for most communities is that health and education systems are fragmented and fail to accommodate families based upon different levels of need. This study utilizes cross-sectoral partnerships to mobilize three vectors (pediatricians, community health workers and parenting educators) to optimize the delivery of vital information and resources to a diverse population of families with ACEs. All vectors are trained in an evidence-informed curriculum to strengthen families and build youth resilience. The study design is a randomized controlled trial of 340 families of children between the ages of 3 to 11 who are generally healthy and have recently seen a pediatrician for a well-child visit. To evaluate the efficacy of this intervention, pediatric patients are invited to participate in repeat evaluations within 2 weeks, 3 months, 6 months, and 12 months after their well-child visit. The study will evaluate the following: 1) the association between Child-ACE scores and biomarkers of toxic stress at baseline in children age 3-11 years old; 2) whether the intervention reduces toxic stress and child health and psychosocial problems at follow-up for children with ACEs compared to usual well-child care for children with ACEs; and 3) the impact of mediating and moderating variables. These results will demonstrate that for families with ACEs the intervention will decrease toxic stress associated with ACEs, improve health outcomes, and reduce health disparities.
Conditions Studied
Interventions
- BEHAVIORAL Three-Tier Model
Study Locations (1)
California
- Loma Linda University — Loma Linda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2022-05-24 |
| Est. Completion | 2027-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05388864
The ClinicalTrials.gov registry entry for NCT05388864 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 191 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Adverse Childhood Experiences appearing as the primary indexed condition, and to 1 intervention — of which Three-Tier Model is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05388864 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05388864 about?
NCT05388864 is a clinical study titled "Building Resilient Families". Prior research suggests that it is possible to improve health outcomes in children with ACEs through multi-component interventions. The challenge for most communities is that health and education systems are fragmented and fail to accommodate families based upon different levels of need. This study ...
What is the current status of trial NCT05388864?
This trial is currently recruiting. It is a NA study. The enrollment target is 340 participants. The study started on 2022-05-24. Estimated completion is 2027-05.
What conditions does trial NCT05388864 study?
This clinical trial studies the following conditions: Adverse Childhood Experiences. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05388864?
The interventions under investigation include: Three-Tier Model (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05388864?
This trial is sponsored by Loma Linda University, which has 191 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05388864 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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