NEXUS Ultrasound Intervention for Substance Use Disorders in Pregnancy

(NEXUS Trial)

Overseen By Andrea Publow

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Cognitive impairment, Psychiatric instability, Fetal anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This exploratory study brings together an interprofessional team, novel tools, and innovative, community-driven care delivery approaches to improve health equity among mother-infant dyads impacted by substance use disorder and high risk for poor health outcomes. This study will test a community-informed and community-based intervention using a fetal ultrasound protocol, motivational interviewing techniques, strength-based education, and healthcare coordination strategies to reduce health disparities faced by women and their children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the NEXUS treatment for substance use disorders in pregnancy?

The effectiveness of treatments similar to NEXUS, like the Parent-Child Assistance Program (PCAP) and Early Start, shows that structured support and counseling can reduce substance use during pregnancy and improve outcomes for both mothers and babies. These programs have demonstrated success in promoting abstinence, improving engagement with services, and enhancing overall maternal and child health. ^{1 2 3 4 5}

How is the NEXUS Ultrasound Intervention treatment different from other treatments for substance use disorders in pregnancy?

The NEXUS Ultrasound Intervention is unique because it uses interactive ultrasound consultations to enhance the mother's curiosity about her developing child and motivate her to stay abstinent from substance use, which is not a common approach in other treatments for substance use disorders in pregnancy. ^{1 5 6 7 8}

Eligibility Criteria

This trial is for pregnant individuals aged 18-45, between 22-32 weeks gestation, who have a substance use disorder or are in treatment for it. They must understand English and be willing to follow the study procedures including the NEXUS regimen. Excluded are those with known fetal anomalies, cognitive impairments, psychiatric instability, language/legal barriers, or conditions needing frequent ultrasounds like Gestational Diabetes.

Inclusion Criteria

Provision of signed and dated informed consent form

I am pregnant, aged 18-45, and between 22-32 weeks into my pregnancy.

Not incarcerated

Exclusion Criteria

Presenting with cognitive impairment

Psychiatric instability (active psychosis or acute mania)

Language or legal barriers that would limit the patient's ability to provide informed consent and complete research assessments

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Intervention

Participants receive the NEXUS fetal ultrasound protocol with motivational interviewing and education focused on maternal-fetal connection

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for substance use treatment utilization and maternal-fetal attachment after delivery

12 weeks postpartum

2 visits (in-person)

Postpartum Monitoring

Participants' perceived stress and obstetric complications are assessed

12 weeks postpartum

Treatment Details

Interventions

• NEXUS intervention
• Standardized Non-Medical fetal ultrasound

Trial Overview The NEXUS intervention combines motivational interviewing techniques with strength-based education and healthcare coordination strategies using a specialized fetal ultrasound protocol. It aims to improve maternal-fetal health among women affected by substance use disorders compared to standard non-medical fetal ultrasound care.

Participant Groups

Group I: NEXUS Intervention Experimental Treatment 2 Interventions

Standardized non-diagnostic fetal ultrasound with motivational interviewing techniques, focused on maternal and fetal strengths.

Group II: Comparator Active Control 1 Intervention

Standardized non-diagnostic fetal ultrasound protocol without interactive intervention to control for time and attention.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Findings from Research

The Parent-Child Assistance Program (PCAP) in Australia showed significant improvements in addiction severity among participants, with 80% achieving periods of abstinence longer than four months and no subsequent alcohol-exposed pregnancies.

Participants reported high satisfaction with the program, and four women successfully had their children returned to their care, indicating positive outcomes for both mothers and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurturing families: One year pilot outcomes for a modified Parent Child Assistance Program in Australia. Symons, M., Finlay-Jones, A., Meehan, J., et al.[2023]

The Early Start prenatal substance abuse treatment program significantly improved perinatal outcomes for women who were treated, showing lower rates of preterm delivery, placental abruption, and intrauterine fetal demise compared to those who were screened positive but not treated.

Among the 49,985 women studied, those who received treatment (2073 women) had outcomes similar to or better than those who screened negative, highlighting the effectiveness of integrating substance abuse treatment with prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance abuse treatment linked with prenatal visits improves perinatal outcomes: a new standard. Goler, NC., Armstrong, MA., Taillac, CJ., et al.[2019]

Substance use during pregnancy is common and often overlooked, but implementing universal screening can help identify women at different risk levels for substance use, allowing for tailored interventions.

The recommended approach includes brief advice for low-risk women, brief interventions for moderate-risk women, and referrals to specialty care for high-risk women, which can significantly reduce the negative impacts of substance use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of screening, brief intervention, and referral to treatment in the perinatal period. Wright, TE., Terplan, M., Ondersma, SJ., et al.[2022]

The pilot study involving 21 pregnant women with opioid dependence showed that a patient navigation (PN) intervention significantly improved abstinence from illicit opioids and reduced depression, indicating its potential effectiveness in this population.

Participants also demonstrated increased engagement with substance use treatment services and achieved adequate prenatal care, suggesting that the PN model could enhance overall health outcomes for pregnant women with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. Cochran, GT., Hruschak, V., Abdullah, W., et al.[2023]

The Perinatal Wellness Navigator (PWN) program, tested on 50 high-risk perinatal women (42 with opioid use disorder), led to a significant reduction in daily cigarette consumption by an average of 10 cigarettes and decreased nicotine dependence after the intervention.

Participants also reported lower levels of postnatal depression and perceived stress, indicating that while total tobacco abstinence was not achieved, the program effectively improved overall mental health and reduced smoking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal Navigator Approach to Smoking Cessation for Women With Prevalent Opioid Dependence. Fallin-Bennett, A., Rademacher, K., Dye, H., et al.[2020]

Buprenorphine was well tolerated by 15 opioid-dependent pregnant women, with minimal withdrawal symptoms and negligible illicit opioid use, indicating its safety for maternal use during pregnancy.

The incidence of neonatal abstinence syndrome (NAS) was low, with most neonates showing no symptoms or only mild symptoms, suggesting that buprenorphine is effective in managing opioid dependence in pregnant women without significant risks to the fetus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of opioid-dependent pregnant women with buprenorphine. Fischer, G., Johnson, RE., Eder, H., et al.[2019]

The e-SBI-HV is a newly developed digital screening and brief intervention program tailored for home visiting contexts, designed to help pregnant and postpartum women address substance use while maintaining confidentiality and avoiding fears of child protective services involvement.

Based on user-centered design involving 24 participants (17 home visitors and 7 clients), the e-SBI-HV addresses specific needs and concerns of the target population, showing promise in filling gaps in home visiting services for substance use support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Electronic Screening and Brief Intervention to Address Perinatal Substance Use in Home Visiting: Qualitative User-Centered Approach. Dauber, S., Hammond, C., Hogue, A., et al.[2023]

A new prenatal intervention for substance-abusing pregnant women was developed in a public healthcare setting in Finland, focusing on enhancing maternal curiosity about their developing child and motivating abstinence from substance use.

The intervention includes interactive ultrasound consultations and a pregnancy diary, both designed to promote parental mentalization, and was evaluated with a sample of 90 participants, highlighting its potential applicability to other groups and settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SUBSTANCE-ABUSING PREGNANT WOMEN: PRENATAL INTERVENTION USING ULTRASOUND CONSULTATION AND MENTALIZATION TO ENHANCE THE MOTHER-CHILD RELATIONSHIP AND REDUCE SUBSTANCE USE. Pajulo, H., Pajulo, M., Jussila, H., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nurturing families: One year pilot outcomes for a modified Parent Child Assistance Program in Australia. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Substance abuse treatment linked with prenatal visits improves perinatal outcomes: a new standard. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The role of screening, brief intervention, and referral to treatment in the perinatal period. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Perinatal Navigator Approach to Smoking Cessation for Women With Prevalent Opioid Dependence. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Treatment of opioid-dependent pregnant women with buprenorphine. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

Development of an Electronic Screening and Brief Intervention to Address Perinatal Substance Use in Home Visiting: Qualitative User-Centered Approach. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

SUBSTANCE-ABUSING PREGNANT WOMEN: PRENATAL INTERVENTION USING ULTRASOUND CONSULTATION AND MENTALIZATION TO ENHANCE THE MOTHER-CHILD RELATIONSHIP AND REDUCE SUBSTANCE USE. [2017]