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

NCT05731557 | Completed

• 1 other identifier: 20-025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Childhood Experiences

Outcome Measures

Primary Outcomes (2)

• Rate of Emergency Room Visits in the First Year of Life

  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.

  At 12 months of age of the baby

• Rate of adherence to AAP vaccination guideline in the First Year of Life

  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.

  At 12 months of age of the baby

Secondary Outcomes (4)

• Substance Use Program Continuation

  Documentation will be evaluated at 12 months postpartum

• Custody of the child at discharge

  At time of neonatal discharge

• Custody of the child at 12 month of life

  Documentation will be evaluated at 12 months post-partum

• Child development and growth over 2 years

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be English-speaking women between 12 weeks 0 days of pregnancy and 1 month postpartum who are 18 years and older, and their child, newborn, or neonate (newborn) of uncertain viability who are being seen at Cooper University Hospital.

You may qualify if:

• Women between 12 weeks 0 days of pregnancy and 1 month postpartum AND 18 years and older

You may not qualify if:

• Women younger than 18 and/ or non-English speaking patients who cannot give informed consent

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Related Publications (4)

• Bellis MA, Hughes K, Leckenby N, Hardcastle KA, Perkins C, Lowey H. Measuring mortality and the burden of adult disease associated with adverse childhood experiences in England: a national survey. J Public Health (Oxf). 2015 Sep;37(3):445-54. doi: 10.1093/pubmed/fdu065. Epub 2014 Aug 30.

  PMID: 25174044 RESULT

• Exley D, Norman A, Hyland M. Adverse childhood experience and asthma onset: a systematic review. Eur Respir Rev. 2015 Jun;24(136):299-305. doi: 10.1183/16000617.00004114.

  PMID: 26028641 RESULT

• Su S, Wang X, Pollock JS, Treiber FA, Xu X, Snieder H, McCall WV, Stefanek M, Harshfield GA. Adverse childhood experiences and blood pressure trajectories from childhood to young adulthood: the Georgia stress and Heart study. Circulation. 2015 May 12;131(19):1674-81. doi: 10.1161/CIRCULATIONAHA.114.013104. Epub 2015 Apr 9.

  PMID: 25858196 RESULT

• Stein MD, Conti MT, Kenney S, Anderson BJ, Flori JN, Risi MM, Bailey GL. Adverse childhood experience effects on opioid use initiation, injection drug use, and overdose among persons with opioid use disorder. Drug Alcohol Depend. 2017 Oct 1;179:325-329. doi: 10.1016/j.drugalcdep.2017.07.007. Epub 2017 Aug 5.

  PMID: 28841495 RESULT

Related Links

• Related Info

Study Officials

• Leslie Abraham

  Cooper Medical School of Rowan University

  PRINCIPAL INVESTIGATOR

• Hsiao-wei M Banks

  Cooper Medical School of Rowan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, Principal Investigator

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: February 16, 2023
• Study Start: August 3, 2020
• Primary Completion: June 2, 2024
• Study Completion: October 5, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)