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Adverse Childhood ExperiencesNCT05731557

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

An observational study of Adverse Childhood Experiences, run by Cooper Norcross Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Adverse Childhood Experiences
How many people
120 participants
Where
1 siteUnited States
Study dates
3 Aug 2020to 5 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cooper University Hospital

    Camden, New Jersey, 08103

Other trials in United States

About this study

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 12 months of age of the baby

  2. 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.

    Measured: At 12 months of age of the baby

Secondary outcomes (4)

  1. Substance Use Program Continuation

    We will document if the mother continued with substance use treatment program as applicable

    Measured: Documentation will be evaluated at 12 months postpartum

  2. Custody of the child at discharge

    We will document whether the biological mother was discharged from the hospital with custody of the child

    Measured: At time of neonatal discharge

  3. Custody of the child at 12 month of life

    We will document whether the biological mother had custody of her child at 12 months post partum

    Measured: Documentation will be evaluated at 12 months post-partum

  4. Child development and growth over 2 years

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start3 Aug 2020
  3. Primary completion2 Jun 2024
  4. Study completion5 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Other
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05731557
Sponsor's protocol ID
20-025
Status last verified
Oct 2024
First submitted
7 Mar 2022
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25174044

  • 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.

    PubMed 26028641

  • 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.

    PubMed 25858196

  • 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.

    PubMed 28841495

Questions about this trial

What is this clinical trial studying?

An observational study of Adverse Childhood Experiences, run by Cooper Norcross Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Emergency Room Visits in the First Year of Life (time frame: At 12 months of age of the baby). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05731557, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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