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NCT05388864 · ClinicalTrials.gov registry record · NA
Building Resilient Families
A NA study of Adverse Childhood Experiences, sponsored by Loma Linda University.
- Recruiting
- Registry status
- NA
- Development phase
- 340
- Enrollment target
- 1
- Study location
NCT05388864: Recruiting NA study of Adverse Childhood Experiences, sponsored by Loma Linda University.
NCT05388864 is a NA study of Adverse Childhood Experiences that is actively recruiting participants, run by Loma Linda University. The registered enrollment target is 340 participants, above the 304-participant average among 13 other Adverse Childhood Experiences trials with a reported enrollment target (12% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05388864, a NA study of Adverse Childhood Experiences, is actively recruiting participants, sponsored by Loma Linda University.
- RECRUITING
- Registry status
- NA
- Development phase
- 340 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
A composite measurement that combines biometric data, neuroendocrine and immune markers, and executive function to determine whether the intervention lowers physiologic stress for children with ACEs. Each group will be followed over one year and growth curves will be analyzed to compare change in physiologic stress between baseline and final follow-up.
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 |
What NCT05388864 shows while recruiting
NCT05388864 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, above the 304-participant average among 13 other Adverse Childhood Experiences trials with a reported enrollment target (12% higher).
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.
NCT05388864 reports a single indexed study location in California.
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.
What interventions are being tested in trial NCT05388864?
The interventions under investigation include: Three-Tier Model (BEHAVIORAL).
Who is sponsoring clinical trial NCT05388864?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05388864's enrollment target sits among peer trials
340 3rd of 13 higher than 11 of 13 other Adverse Childhood Experiences trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adverse Childhood Experiences trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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