| NCT ID | NCT05388864 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Loma Linda University |
| Condition | Adverse Childhood Experiences |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2022-05-24 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 340 participants in total. It began in 2022-05-24 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Ages 3-11 * Seen for a well-child visit at a participating pediatric clinic Exclusion Criteria: * \< 3 years or \>11 years of age * Significant congenital medical problems * Previous participation in parenting program (last 12 months) * Sibling enrollment in current study
Contact & Investigator
Ariane Marie-Mitchell, MD, PhD, MPH
PRINCIPAL INVESTIGATOR
Loma Linda University
Frequently Asked Questions
Who can join the NCT05388864 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 11 Years, studying Adverse Childhood Experiences. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05388864 currently recruiting?
Yes, NCT05388864 is actively recruiting participants. Contact the research team at amariemitchell@llu.edu for enrollment information.
Where is the NCT05388864 trial being conducted?
This trial is being conducted at Loma Linda, United States.
Who is sponsoring the NCT05388864 clinical trial?
NCT05388864 is sponsored by Loma Linda University. The principal investigator is Ariane Marie-Mitchell, MD, PhD, MPH at Loma Linda University. The trial plans to enroll 340 participants.