Three-Tier Support Model for Adverse Childhood Experiences

AM
Overseen ByAriane Marie-Mitchell, MD, PhD, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Loma Linda University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new support model, the Three-Tier Model, to assist children aged 3 to 11 who have experienced adverse childhood experiences (ACEs). The goal is to determine if a combined effort by pediatricians, community health workers, and parenting educators can improve children's health and reduce stress from difficult early life events. Participating families will receive extra support and follow-up assessments over a year. Ideal candidates for this trial are children who have recently had a well-child visit and have faced challenging early experiences. As an unphased trial, this study offers families the chance to contribute to innovative research that could shape future support systems for children facing similar challenges.

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 prior data suggests that this Three-Tier Model is safe for children with ACEs?

Research has shown that programs like the Three-Tier Model can improve the health of children who have faced difficult experiences. This model involves a team of doctors, community health workers, and parenting educators who collaborate to provide families with essential resources and support.

Regarding safety, the program does not involve medications, so risks remain very low. It focuses on offering education and support, which is generally safe and well-received. Families receive guidance and information to help them manage better, with little risk of harm.

Similar studies have not reported any major negative effects from these types of programs. They primarily aim to enhance the well-being of children and families. While staying informed and asking questions is always important, current research suggests the program's safety is reassuring.12345

Why are researchers excited about this trial?

Researchers are excited about the Three-Tier Support Model for Adverse Childhood Experiences (ACEs) because it offers a structured, early intervention approach that prioritizes the holistic well-being of children. Unlike standard well-child care, this model involves training providers to specifically address and mitigate the impacts of ACEs on children, potentially reducing long-term negative health outcomes. By focusing on personalized care and early support, this model aims to break the cycle of trauma and foster resilience, setting it apart from traditional methods that may not directly target the root causes of behavioral and emotional challenges stemming from ACEs.

What evidence suggests that the Three-Tier Model is effective for improving health outcomes in children with ACEs?

This trial will evaluate the effectiveness of the Three-Tier Model in supporting children with adverse childhood experiences (ACEs). Research has shown that building resilience in children can significantly improve their mental health, particularly for those with challenging backgrounds. Studies have found that focusing on resilience can reduce the long-term negative effects of these experiences, such as mental health issues and ongoing health problems. Key factors include effective emotion management and having supportive individuals around. Previous evidence suggests that combining community support, like assistance from doctors and teachers, effectively strengthens these protective factors. This approach aims to reduce stress and enhance the overall health of children facing these challenges.26789

Who Is on the Research Team?

AM

Ariane Marie-Mitchell, MD, PhD, MPH

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

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
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Three-Tier ModelExperimental Treatment1 Intervention
Group II: Comparison GroupActive Control1 Intervention
Group III: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials
322
Recruited
267,000+

Published Research Related to This Trial

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

Citations

The effect of multiple adverse childhood experiences on ...The outcomes most strongly associated with multiple ACEs represent ACE risks for the next generation (eg, violence, mental illness, and substance use). To ...
Comparing the relationship between three resilience ...Comparing the relationship between three resilience frameworks and mental health outcomes among children who experienced multiple adverse childhood experiences.
Adverse childhood experiences: a meta‐analysis of ...Adverse childhood experiences: a meta‐analysis of prevalence and moderators among half a million adults in 206 studies
Adverse childhood experiences and chronic health outcomes ...Recent evidence suggests a significant association between adverse childhood experience (ACE) and chronic health outcomes among U.S. adults.
Adverse Childhood Experiences, Protective Factors, and ...The strongest protective factors against childhood obesity were strong self-regulation, mastery/after-school activities, and living in a supportive ...
About Adverse Childhood ExperiencesThis page defines adverse childhood experiences, presents the latest data, and describes outcomes.
Comparison of Three Models of Adverse Childhood ...According to the DMAP approach, distinct types of adversity experiences have unique effects on the development of emotional, cognitive, and ...
Evaluating the effects of adverse childhood experiences ...ACEs can lead to subsequent negative physical and mental health outcomes for both youth and adults, including a 1200 % increased risk of suicide (Ross et al., ...
Youth Risk Behavior Survey, United States, 2023 | MMWRThis report describes adverse childhood experiences among U.S. high school students.
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