Skip to main content
OpenTrials
Completed

NCT Number: NCT05731557

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cooper University Hospital

Camden, New Jersey, 08103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of Emergency Room Visits in the First Year of Life

    Time frame: 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

    Time frame: 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 outcomes

  1. Substance Use Program Continuation

    Time frame: 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

    Time frame: 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

    Time frame: 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

  4. Child development and growth over 2 years

    Time frame: Documentation will be evaluated at 12 and 24 months post-partum

    We will document the development and growth of the child of the mother filling out ACE information at at 12 and 24 months post partum

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.