Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05731557
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2022-03-07
Brief Title:
ACE Resilience and Substance Use Disorder Maternal and Baby Outcomes in the First Year of Life
Sponsor:
The Cooper Health System
Organization:
The Cooper Health System
Study Overview
Official Title:
ACE Resilience and Substance Use Disorder Maternal and Baby Outcomes in the First Year of Life
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 54 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 involvement10 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 trauma1213 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 individuals 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None