Building Resilient Families

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-24

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implementation of Adverse Childhood Experiences (ACEs) Policy

NCT04916587

Adverse Childhood Experiences

COMPLETED NA

Mitigating ACEs in Pediatric Primary Care

NCT03058861

Violence Parenting

COMPLETED NA

Helping Families Pilot of a Family Resilience Program for Families Experiencing Homelessness

NCT04273126

Family Relationship Coping Skills

COMPLETED NA

The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children

NCT05129501

Adverse Childhood Experiences Domestic Violence

COMPLETED NA

Resilient Families Open Pilot: Dyadic Resiliency Intervention

NCT06239571

Parents

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adverse Childhood Experiences

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

The pediatric patients, their caregivers and teachers are blinded to arm type.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Three-Tier Model

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

Group Type EXPERIMENTAL

Three-Tier Model

Intervention Type BEHAVIORAL

Families in the intervention will be counseled by a pediatric provider about ACEs, resilience, stress management, and healthy relationships. Families will also be referred to community health workers and parenting educators.

Comparison Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Three-Tier Model

Families in the intervention will be counseled by a pediatric provider about ACEs, resilience, stress management, and healthy relationships. Families will also be referred to community health workers and parenting educators.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes