Three-Tier Support Model for Adverse Childhood Experiences

Overseen By Ariane Marie-Mitchell, MD, PhD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Congenital medical problems, Previous parenting program, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

340 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the Three-Tier Model treatment for adverse childhood experiences?

The systematic review of trials suggests that interventions in pediatric health care can help prevent poor outcomes associated with adverse childhood experiences, indicating that structured support models like the Three-Tier Model may be effective in improving child outcomes. ^{1 2 3 4 5}

How does the Three-Tier Model treatment for adverse childhood experiences differ from other treatments?

The Three-Tier Model is unique because it offers a structured approach to addressing adverse childhood experiences (ACEs) by focusing on different levels of support, which may include individual, family, and community interventions. This model is distinct from other treatments as it aims to provide comprehensive support tailored to the specific needs of individuals affected by ACEs, rather than a one-size-fits-all solution. ^{1 6 7 8 9}

Research Team

Ariane Marie-Mitchell, MD, PhD, MPH

Principal Investigator

Loma Linda University

Eligibility Criteria

This trial is for children aged 3-11 who have experienced adverse childhood events (ACEs) and are generally healthy. They must have recently had a well-child visit at a participating clinic. Children with significant congenital medical issues, those outside the age range, siblings already in the study, or those enrolled in a parenting program within the last year cannot participate.

Inclusion Criteria

I am between the ages of 3 and 11.

Seen for a well-child visit at a participating pediatric clinic

Exclusion Criteria

I am either younger than 3 years old or older than 11 years old.

Previous participation in parenting program (last 12 months)

Sibling enrollment in current study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline Assessment

Initial assessment of Child-ACE scores and biomarkers of toxic stress

1 week

1 visit (in-person)

Intervention

Multi-component intervention involving pediatricians, community health workers, and parenting educators

12 months

4 visits (in-person) at 2 weeks, 3 months, 6 months, and 12 months

Follow-up

Participants are monitored for changes in toxic stress and health outcomes

12 months

4 visits (in-person) at 2 weeks, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• Three-Tier Model

Trial Overview The 'Building Resilient Families' trial tests a Three-Tier Model intervention to help families with ACEs by using pediatricians, community health workers, and parenting educators trained in resilience-building curriculum. It's a randomized controlled trial comparing this model against usual care to see if it reduces toxic stress and improves health outcomes over time.

Participant Groups

Group I: Three-Tier Model Experimental Treatment 1 Intervention

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

Group II: Comparison Group Active Control 1 Intervention

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

Group III: Control Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Findings from Research

In a study of 1,037 urban Emergency Department patients, 53% of males and 60% of females reported experiencing one or more adverse childhood experiences (ACEs), highlighting a significant prevalence of trauma in this population.

The research found that females with a history of maternal domestic violence had higher odds of at-risk drinking, and cumulative ACEs were linked to increased cannabis and illicit drug use among females, indicating a stronger association between ACEs and substance use in women compared to men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse childhood experiences are associated with at-risk drinking, cannabis and illicit drug use in females but not males: an Emergency Department study. Cunradi, CB., Caetano, R., Alter, HJ., et al.[2021]

Cognitive-behavioral therapy (CBT) has the strongest evidence for effectively improving outcomes in children aged 3-18 who have experienced Adverse Childhood Experiences (ACEs), particularly those related to abuse.

Overall, while some psychological therapies and parent training show positive results, many interventions lack conclusive evidence, and there is a significant gap in addressing the broader social factors that contribute to the negative impacts of ACEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to support people exposed to adverse childhood experiences: systematic review of systematic reviews. Lorenc, T., Lester, S., Sutcliffe, K., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

An algorithm using administrative data to measure adverse childhood experiences (ADM-ACE). [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A Systematic Review of Trials to Improve Child Outcomes Associated With Adverse Childhood Experiences. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Adverse childhood experiences are associated with at-risk drinking, cannabis and illicit drug use in females but not males: an Emergency Department study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Interventions to support people exposed to adverse childhood experiences: systematic review of systematic reviews. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Exploring the Relationship Between Adverse Childhood Experiences and Hope. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The Impact of Attachment-Disrupting Adverse Childhood Experiences on Child Behavioral Health. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Modeling life course pathways from adverse childhood experiences to adult mental health. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

A Scoping Review on Adverse Childhood Experiences Studies Using Latent Class Analysis: Strengths and Challenges. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Modeling the Adverse Childhood Experiences Questionnaire-International Version. [2022]