ACE, Resilience, and Substance Use Disorder: Maternal and Baby Outcomes in the First Year of Life
Conditions: Adverse Childhood Experiences
Sponsor: The Cooper Health System

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ACE, Resilience, and Substance Use Disorder: Maternal and Baby Outcomes in 
the First Year of Life 
Investigator: Dr. Alla Kushnir, MD 
Co-Investigators: Leslie Abraham, Hsiao-wei Banks, John P. Gaughan, MS, PhD, MBA, 
Laura Park, MA 
2/19/2020 
1. 
Objective/ Purpose 
The purpose of this study is to understand the maternal factors that contribute to 
the health of an infant born to a mother with substance use disorder (SUD). We 
will evaluate whether or not the outcomes of maternal and baby health can be 
identified early through maternal screening tools, including the Adverse 
Childhood Experience (ACE) questionnaire and the 7Cs Resiliency Tool. 
2. 
Hypothesis 
Mothers with SUDs that have higher maternal ACE scores will have children with 
poor outcomes, including difficulty reaching developmental milestones, poorer 
adherence to vaccination schedule guidelines, and more frequent ER visits in the 
first year of life. However, high maternal resilience scores may counter the high 
ACE scores and allow for improvement of poor health outcomes in these 
populations.  
3. 
Background 
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, 

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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. 
Significance of the Research 
Currently, little research has been conducted to study the relationship between 
ACEs and maternal resilience and the health outcomes of mothers with SUDs 
and their newborn baby. Understanding factors that show a strong correlation 
with maternal and fetal health outcomes would allow health care providers to 
identify risks earlier, offer prenatal interventional care, and provide tailored 
resources for mothers and their infant.
4. 
Study Design 
This is a prospective observational study that will require the initial administration 
of both the ACEs questionnaire and 7Cs resilience tool, followed by one year of 
chart reviews and/or phone calls to follow-up with patients regarding the 
identified outcome measures.  
5. 
Proposed research Plan 
A. Subjects 
Number of subjects: 100 

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Inclusion criteria: Pregnant mother past her 1st trimester of pregnancy 
who is being seen at Cooper University Hospital Addiction Medicine clinic 
or Labor and Delivery or Maternal Fetal Medicine Unit. The subject is 
diagnosed with substance use disorder. 
Exclusion criteria: Mothers under the age of 18. 
Recruiting Methods: Subjects will be recruited through the Addiction 
Medicine clinic at Cooper Hospital. Staff at the clinic will ask any pregnant 
mothers, past their first trimester, if they are interested in participating in 
this study. Interested participants will be contacted by study co-
investigators to learn more about the study. If all inclusion criteria is met, 
the pregnant woman will be invited to participate in the study.  
Informed Consent Process: Prospective subjects will meet with either of 
the study co-investigators named earlier in the proposal. Additionally, 
prospective subjects may meet with the clinical psychologist on the study, 
Laura Park. All subjects will be given a copy of the informed consent to 
read along with the study co-investigators. Potential subjects will be 
invited to a private room away from distractions and will be allowed 
adequate lime to ask questions and read the consent forms.  
Vulnerable Subjects: This study will include vulnerable subjects, namely 
pregnant women and their child. 
Compensation to Subjects: No financial or other compensation will be 
offered to the subjects in exchange for participating in this study. 
Treatment for Research-Related Injuries: No research-related injuries are 
anticipated in relation to participating in this study. If any research-related 
injuries are sustained during the course of this study, the subject may 
reach out to the research investigator or co-investigators to determine the 
appropriate course of action. While conducting ACEs and resilience 
interviews, re-traumatization will be a concern which would be handled by 
the current resources available through the Addiction Medicine clinic and 
Cooper Hospital. 
B. Research Methods and Procedures 
General description of methods and procedures: After consenting to 
participate in this study, pregnant mothers will be provided a modified 
survey based off of the Adverse Childhood Experiences (ACE) 

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questionnaire and 7C Resilience Tool. After giving birth, patient charts will 
be monitored for maternal commitment to treatment, child custody status, 
the number of times the child was admitted to the emergency room, 
adherence to recommended pediatric vaccination schedules, and infant 
developmental milestones. These measurements will be taken over the 
course of 1 year after child birth. 
Summary of visit procedures: Pregnant mothers will meet with any of the 
co-investigators prenatally to complete the ACE questionnaire and 7C 
Resilience Tool. After the initial intake, outcome measures will be 
collected via chart review or verbally through phone call with the mother. 
Data will be collected at birth, 2 months, 4 months, 6 months, and 1 year 
after birth. 
Procedures just for research purposes: The ACEs questionnaire and 7C 
Resilience Tool are not included in standard prenatal care and are solely 
being administered for research purposes. If the subjects were not 
enrolled in this study, the only difference in care would be the absence of 
either screening tool being administered prenatally.  
How participation differs from standard of care/ study duration: As an 
observational study, participating subjects will be provided the appropriate 
standard-of-care.  
Study Duration: Pregnant mothers will be enrolled between March 1, 2020 
to August 1, 2020. All mothers will be followed for one year postpartum. 
The total duration of the project for the individual will be the duration of the 
pregnancy as well as the child’s first year of life. This study will be 
conducted between March 1, 2020 - January 31, 2020.  
Data Analysis Plan, Statistical Tests, and Sample Size Rationale 
Outcome measures being followed at birth of baby, and at 2, 4, 6 and 12 
months after birth: 
1. Is the mother still parenting and have custody of the baby? 
2. Is the mother receiving treatment for substance use disorder? 
3. Has the baby reached expected developmental and health 
milestones after delivery?  
4. How many Emergency Room visits did the baby have postnatally? 
5. Does the child meet vaccination schedule as proposed by the 
CDC?  

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Sample size.  The key outcomes of the study will include binary 
measurements (parenting, custody, continued treatment, etc.) measured 
at 2, 4, 6 and 12 months after birth. These outcomes will be related to the 
pre-natal scores of the ACE and 7C survey tools.  Based on a repeated 
measures design, a sample size of 100 will provide >90% power to detect 
an odds ratio of 2 or greater for each standard deviation above the mean 
of the ACE scale (1-10) assuming a mean of 3.7 and a standard deviation 
of 2.7 and a response proportion of 0.50. 
Data Analysis. The checking, assessment and analysis of the data will be 
carried out in a blinded fashion. Demographic and clinical characteristics 
will be presented using means with standard deviation for continuous 
variables and counts with proportions for categorical variables. The 
statistical analysis will be carried out using “intention-to treat” and “per-
protocol” approaches.  The primary outcomes (parenting, custody, 
continued treatment, etc.) will be analyzed using generalized estimating 
equations (GEE) appropriate for repeated measures over time. Odds 
ratios with 95% confidence intervals for the relationships of ACE and 7C 
with the clinical outcomes will be presented. 
6. 
Risks and benefits 
A. Potential Risks due to Study Participation: No study treatments will be 
included in this observational study. However, in some cases, re-
traumatization is a possibility and necessary resources will be made 
available to the subject.  
B. Minimizing Risks: Risks to subjects will be minimized by the study design, 
which is observational and not anticipated to be risky towards the mother 
or fetus. Subjects being seen at the Addiction Medicine clinic and Labor 
and Delivery Ward will have normal access to treatment and follow-up 
visits, which follows normal standard of care at Cooper Hospital.  
C. Potential Benefits; Potential benefits of this study would be increased 
adherence to substance use disorder (SUD) treatment, appropriate follow-
up with pediatricians per recommended vaccination schedule, and 
identifying risk factors during pregnancy to initiate early intervention 
practices. Society may benefit from this research by understanding the 
risks of ACEs and resilience scores of pregnant mothers suffering from 
SUD and how it affects the care of their newborn child. The findings of this 

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study may benefit the resources and management of mothers with SUD 
during pregnancy and postpartum. 
D. Risk: Benefit Ratio: Due to the absence of risks associated with this study, 
the ratio of risks to benefits is reasonable to individual subjects and 
society.  
7. 
Plans for Monitoring Subject Safety 
Subjects are being enrolled in an observational study, there are no anticipated 
adverse events during the course of this study. However, in some cases, re-
traumatization may be possible and necessary resources will be made available 
to the subject.  
8. 
Procedures to Maintain Privacy and Confidentiality 
All information obtained in this study will be strictly confidential, except, as may 
be required by law. Each mother and infant will be assigned a number and 
patient’s name and identifying information with that number will be kept in a 
separate locked cabinet. We will use only the assigned number to the infants on 
the data sheet. All the files and records created for this study will be stored in Dr. 
Kushnir’s office at 755 Dorrance and Cooper Hospital in a locked cabinet or in a 
computer with a password. Any publication resulting from this study will refer to 
the patient by a pre-assigned number. No published data will disclose the identity 
of any patient. 
References 
1. Center for Disease Control and Prevention. (2019, December 31, 2019). 
Preventing Adverse Childhood Experiences. Retrieved from
https://www.cdc.gov/violenceprevention/childabuseandneglect/aces/fastfact.html
?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fviolenceprevention%2Fc
hildabuseandneglect%2Facestudy%2Faboutace.html
2. Bellis, M. A., Hughes, K., Leckenby, N., Hardcastle, K. A., Perkins, C., & Lowey, 
H. (2015). Measuring mortality and the burden of adult disease associated with 
adverse childhood experiences in England: a national survey. J Public Health 
(Oxf), 37(3), 445-454. doi:10.1093/pubmed/fdu065 

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3. Exley, D., Norman, A., & Hyland, M. (2015). Adverse childhood experience and 
asthma onset: a systematic review. European Respiratory Review, 24(136), 299-
305. doi:10.1183/16000617.00004114 
4. Su, S., Wang, X., Pollock, J. S., Treiber, F. A., Xu, X., Snieder, H., . . . Harshfield, 
G. A. (2015). Adverse childhood experiences and blood pressure trajectories 
from childhood to young adulthood: the Georgia stress and Heart study. 
Circulation, 131(19), 1674-1681. doi:10.1161/circulationaha.114.013104 
5. Stein, M. D., Conti, M. T., Kenney, S., Anderson, B. J., Flori, J. N., Risi, M. M., & 
Bailey, G. L. (2017). Adverse childhood experience effects on opioid use 
initiation, injection drug use, and overdose among persons with opioid use 
disorder. Drug Alcohol Depend, 179, 325-329. 
doi:10.1016/j.drugalcdep.2017.07.007 
6. Substance Abuse and Mental health Services Administration. (2018). 2018 
National Survey on Drug Use and Health:Women. Retrieved from
https://www.samhsa.gov/data/sites/default/files/reports/rpt23250/5_Women_2020
_01_14.pdf
7. Chung, E. K., Nurmohamed, L., Mathew, L., Elo, I. T., Coyne, J. C., & Culhane, 
J. F. (2010). Risky health behaviors among mothers-to-be: the impact of adverse 
childhood experiences. Acad Pediatr, 10(4), 245-251. 
doi:10.1016/j.acap.2010.04.003 
8. Racine, N., Plamondon, A., Madigan, S., McDonald, S., & Tough, S. (2018). 
Maternal Adverse Childhood Experiences and Infant Development. Pediatrics, 
141(4), e20172495. doi:10.1542/peds.2017-2495 
9. Azuine, R. E., Ji, Y., Chang, H.-Y., Kim, Y., Ji, H., DiBari, J., . . . Wang, X. (2019). 
Prenatal Risk Factors and Perinatal and Postnatal Outcomes Associated With 
Maternal Opioid Exposure in an Urban, Low-Income, Multiethnic US Population. 
JAMA Network Open, 2(6), e196405-e196405. 
doi:10.1001/jamanetworkopen.2019.6405 
10. Arria, A. M., Mericle, A. A., Meyers, K., & Winters, K. C. (2012). Parental 
substance use impairment, parenting and substance use disorder risk. J Subst 
Abuse Treat, 43(1), 114-122. doi:10.1016/j.jsat.2011.10.001 

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11. Leitch, L. (2017). Action steps using ACEs and trauma-informed care: a 
resilience model. Health Justice, 5(1), 5. doi:10.1186/s40352-017-0050-5 
12. Fuller, A. E., Garg, A., Brown, N. M., Tripodis, Y., Oyeku, S. O., & Gross, R. S. 
(2020). Relationships Between Material Hardship, Resilience, and Health Care 
Use. Pediatrics, e20191975. doi:10.1542/peds.2019-1975 
13. Masten, A. S. (2001). Ordinary magic: Resilience processes in development. 
American Psychologist, 56(3), 227-238. doi:10.1037/0003-066X.56.3.227 
14. Barger, J., Vitale, P., Gaughan, J. P., & Feldman-Winter, L. (2017). Measuring 
Resilience in the Adolescent Population: A Succinct Tool for Outpatient 
Adolescent Health. J Pediatr, 189, 201-206.e203. 
doi:10.1016/j.jpeds.2017.06.030