Building Resilient Families

Loma Linda University (LLU)

Status: Enrolling

Conditions: Adverse Childhood Experiences

Treatments: Behavioral: Three-Tier Model

Study type: Interventional

Funder types: Other

Identifiers

NCT05388864

5180358

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 3 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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340 participants in 3 patient groups

Three-Tier Model

Experimental group

Description:

130 children with ACEs who received well-child care by a trained provider will be enrolled in this group.

Treatment:

Behavioral: Three-Tier Model

Comparison Group

No Intervention group

Description:

80 children without ACEs who received usual well-child care will be enrolled in this group.

Control Group

No Intervention group

Description:

130 children with ACEs who received usual well-child care will be enrolled in this group.