ACE, Resilience, and Substance Use Disorder: Maternal and Baby Outcomes in the First Year of Life

Sponsor
The Cooper Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT05731557
Collaborator
(none)
100
1
57.4
1.7

Study Details

Study Description

Brief Summary

The purpose of this study is to understand maternal factors, including ACE and 7Cs Tool scores, and how they contribute to the health of mothers and their infant. The study will evaluate whether or not the outcomes of maternal and baby health can be identified early through the Adverse Childhood Experiences (ACE) questionnaire, 7Cs Tool questionnaire, and Maternal Health Questionnaire.

Additionally, the study will ask questions regarding current maternal social factors that could influence labor and delivery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Adverse Childhood Experiences (ACEs) are traumatic or life-threatening events that occurred to an individual during the ages 0-17 and are measured with the ACE Score questionnaire. These experiences include being a victim of physical and sexual abuse, neglect, and exposure to household dysfunction such as parental substance abuse or incarceration1. Multiple studies have shown that the number of ACEs an individual experiences correlates with his or her risk in developing chronic health issues such as diabetes, asthma, and hypertension later in life 2-4. In addition, ACEs correlate with a higher risk of engaging in risky behaviors such as substance use5. A recent survey conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA) showed that 5.4% of pregnant mothers had used illicit drugs including marijuana, opioids, and cocaine in the past month6. Moreover, ACE scores of pregnant women have been linked to poor coping mechanisms such as illicit drug use during pregnancy7. These scores also impact prenatal, perinatal, and post-natal health8. For example, babies who were exposed to opioids in utero had significant associations with poorer health outcomes and delays in developmental stages9. Another study concluded that mothers suffering from substance use disorder engage in poor parenting practices such as "limited or absent parental monitoring and lower levels of parental involvement."10 Currently, many medical practices are using ACE scores as a general screening tool to help identify health risks and provide individualized care and family support11. Recent studies show that identifying positive childhood experiences is important when evaluating the impact of ACEs. Protective factors, such as resilience, can offset the negative health impacts of trauma12,13. Described as good outcomes in the face of a threat to wellbeing13, resilience can be quantified by using a questionnaire called the 7Cs tool14. The 7Cs tool, which examines an individual's competence, confidence, character, connection, contribution, coping and control, is a valid method to measure resilience. Currently, the 7Cs tool is internally validated for adolescents that have experienced trauma, and it has shown a correlation between better outcomes with a higher resilience score despite having higher ACE scores. Overall, there is limited information regarding ways to identify and determine the health impact of maternal resilience. More research is necessary to understand how ACEs and resilience affect postpartum outcomes in mothers with SUD and their child.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Other
    Official Title:
    ACE, Resilience, and Substance Use Disorder: Maternal and Baby Outcomes in the First Year of Life
    Actual Study Start Date :
    Aug 3, 2020
    Anticipated Primary Completion Date :
    Aug 2, 2024
    Anticipated Study Completion Date :
    May 15, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Emergency Room Visits in the First Year of Life [At 12 months of age of the baby]

      Emergency Room Visits over the first year will be evaluated at 12 months after the child's birth and will note the number of emergency room visits during the year.

    2. Rate of adherence to AAP vaccination guideline in the First Year of Life [At 12 months of age of the baby]

      Vaccination Adherence over the first year will be evaluated at 12 months after the child's birth and will note adherence to the AAP guideline for 2, 4, 6 month vaccines.

    Secondary Outcome Measures

    1. Substance Use Program Continuation [Documentation will be evaluated at 12 months postpartum]

      We will document if the mother continued with substance use treatment program as applicable

    2. Custody of the child at discharge [At time of neonatal discharge]

      We will document whether the biological mother was discharged from the hospital with custody of the child

    3. Custody of the child at 12 month of life [Documentation will be evaluated at 12 months post-partum]

      We will document whether the biological mother had custody of her child at 12 months post partum

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women between 12 weeks 0 days of pregnancy and 1 month postpartum AND 18 years and older
    Exclusion Criteria:
    • Women younger than 18 and/ or non-English speaking patients who cannot give informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cooper University Hospital Camden New Jersey United States 08103

    Sponsors and Collaborators

    • The Cooper Health System

    Investigators

    • Principal Investigator: Leslie Abraham, Cooper Medical School of Rowan University
    • Principal Investigator: Hsiao-wei M Banks, Cooper Medical School of Rowan University

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Alla Kushnir, Associate Professor of Pediatrics, Principal Investigator, The Cooper Health System
    ClinicalTrials.gov Identifier:
    NCT05731557
    Other Study ID Numbers:
    • 20-025
    First Posted:
    Feb 16, 2023
    Last Update Posted:
    Feb 16, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 16, 2023