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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05731557
Enrollment
120
Registered
2023-02-16
Start date
2020-08-03
Completion date
2024-10-05
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Childhood Experiences

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.

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.

Interventions

None listed

Sponsors

The Cooper Health System
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Emergency Room Visits in the First Year of LifeAt 12 months of age of the babyEmergency 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.
Rate of adherence to AAP vaccination guideline in the First Year of LifeAt 12 months of age of the babyVaccination 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

MeasureTime frameDescription
Substance Use Program ContinuationDocumentation will be evaluated at 12 months postpartumWe will document if the mother continued with substance use treatment program as applicable
Custody of the child at dischargeAt time of neonatal dischargeWe will document whether the biological mother was discharged from the hospital with custody of the child
Custody of the child at 12 month of lifeDocumentation will be evaluated at 12 months post-partumWe will document whether the biological mother had custody of her child at 12 months post partum
Child development and growth over 2 yearsDocumentation will be evaluated at 12 and 24 months post-partumWe will document the development and growth of the child of the mother filling out ACE information at at 12 and 24 months post partum

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026