Clinical trial NCT05388864: Building Resilient Families
Official title: A Multi-Component Intervention to Strengthen Families With Adverse Childhood Experiences (ACEs)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adverse Childhood Experiences
Keywords: adverse childhood experiences
pediatrics
prevention
preventive health services
quality improvement
childhood abuse and neglect
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 340
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pediatric providers are randomized to training on the intervention or usual well-child care. Three groups of patients are recruited to evaluate the efficacy of the intervention: 1) Usual well-child care for children with no ACEs; 2) Usual well-child care for children with ACEs; and 3) Well-child care by providers trained in the intervention.
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Child Allostatic Load Index
timeFrame: Change between baseline and visit 4 (1-year post-enrollment)
Secondary outcomes:
measure: Pediatric Symptom Checklist (PSC)
timeFrame: Change between baseline and visit 4 (1-year post-enrollment)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Ariane Marie-Mitchell, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: