What side effects are associated with this type of intervention?

Common treatments for child development issues, particularly those influenced by caregiver ACEs, include psychological and behavioral interventions such as trauma-focused cognitive behavioral therapy (TF-CBT) and parent-child interaction therapy (PCIT). Known side effects of these treatments are generally minimal but can include temporary increases in distress or anxiety as traumatic memories are processed. Additionally, there may be challenges in maintaining engagement and adherence to therapy, which can impact the overall effectiveness of the treatment.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of conditions that can impact child development, particularly those related to neuropsychiatric disorders. For instance, drugs like atomoxetine and guanfacine have been approved for ADHD, which can be influenced by adverse childhood experiences. Additionally, SSRIs such as fluoxetine and sertraline have been approved for treating anxiety and depression in children, conditions that can also be exacerbated by ACEs. These treatments aim to mitigate the impact of early adverse experiences on child development by addressing the resultant behavioral and emotional disorders.

What other types of research exist?

Promising alternatives to provider-led discussions on caregiver ACEs for child development patients include: 1) Technology-based interventions such as mobile apps and online platforms that provide resources and support for caregivers. 2) Community-based support programs that offer peer support and group counseling. 3) Integrative health approaches that incorporate mindfulness, stress reduction techniques, and complementary therapies to address caregiver well-being.

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Provider Training for ACE Discussions in Child Development

N/A

Waitlist Available

Led By Abigail Lott, PhD, ABPP

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Caregivers who are under the age of 18 years will also be excluded

Caregivers will be excluded if they are unable to speak and read either English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 week post-intervention, 6 months follow up, 18 months follow up

Awards & highlights

No Placebo-Only Group

Summary

This study will see if asking caregivers about their difficult childhood experiences and discussing these with doctors can help improve the health of their infants. The study focuses on caregivers of infants at a clinic serving mostly Hispanic families. The goal is to see if understanding and talking about past hardships can lead to better parenting and healthier children.

Who is the study for?

This study is for caregivers bringing children to specific well-child checkups (4, 6, 9, 15, or 18 months) at the MCC. Participants should be able to speak and read English or Spanish fluently. Caregivers under age 18 or previously enrolled with another child are excluded.

What is being tested?

The trial tests if caregiver training on Adverse Childhood Experiences (ACEs) can reduce their children's emergency visits and missed appointments by increasing awareness of ACEs' impact on child health.

What are the potential side effects?

Since this trial involves educational training rather than medical interventions, traditional side effects are not applicable. However, discussing ACEs may cause emotional discomfort.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am over 18 years old.

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I can speak and read either English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 week post-intervention, 6 months follow up, 18 months follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 week post-intervention, 6 months follow up, 18 months follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week post-intervention, 6 months follow up, 18 months follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of emergency department (ED) visits documented in chart at 18 months post-intervention

Number of medical visits at Mercy Care at 18 months post-intervention

Number or urgent care (UC) visits documented in chart at 18 months post-intervention

Secondary study objectives

Attendance at well child check (WCC) visits at 18 months post-intervention

Change in Brief Resilience Scale score from baseline

Change in Parenting Questionnaire (PQ) warmth subscale (PQ-warmth) score from Baseline

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

Intervention providers will undergo training for ACEs screening and discussion. Eligible families will be enrolled into the study at the intake of their child's 4-month, 6-month, 9-month, 15-month, or 18-month well child check. Caregivers will complete the intake surveys including demographics, caregiver ACEs, resilience, warmth, PTSD, and depression. The providers will lead a discussion regarding the impact of caregiver ACEs. Patients will be contacted 1-week, 6-months, and 18-months following their enrollment to obtain repeat measures of the survey instruments. At the 18-month time point, the electronic medical record (EMR) will be queried to obtain outcome measures.

Group II: Standard of Care ArmActive Control1 Intervention

During the study period, standard of care providers will continue to provide standard of care treatment(s); however, families receiving care from the standard of care providers will complete all study surveys. Instead of ACEs training, standard of care providers will undergo training on study procedures including obtaining survey instruments from caregivers and proper storage of survey instruments. This training will stress the importance of not reviewing caregiver ACE scores and minimizing possible treatment contamination. However, standard of care providers will still be able to provide resources to the families as part of standard of care.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Provider-led discussions on caregiver Adverse Childhood Experiences (ACEs) aim to increase caregiver awareness of their own past traumas, which can influence their parenting practices and stress levels. By addressing these issues, caregivers can develop healthier coping mechanisms and provide a more supportive environment for their children. This, in turn, can lead to fewer emergency department visits, reduced urgent care needs, and fewer missed primary care appointments for the child. The mechanism of action here involves breaking the cycle of trauma and stress, thereby promoting better mental and physical health outcomes for children.

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