STARS + Maternal Support for Substance Use During Pregnancy

Overseen By Geneva Marshall, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Non-English speakers, Outside Oklahoma City, others

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

Compensation: Varies

Number of Visits: 12

Duration: Up to 12 months

242 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist pregnant women dealing with substance abuse by comparing two support methods. Participants will receive care either at the STAR (Substance Use Treatment and Recovery) prenatal clinic or at STAR plus home visits from a therapist focused on parenting and substance-exposed babies, known as the STARS + maternal Attachment Biobehavioral Catchup home visiting model. The study will also observe women who choose not to receive care at STAR for comparison. It is suitable for English-speaking pregnant women in the Oklahoma City area experiencing substance use issues. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance support methods for pregnant women facing similar challenges.

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's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the STAR Prenatal Clinic provides thorough prenatal care for pregnant women dealing with substance use issues. This care includes support services and assistance from recovery specialists with similar experiences. The clinic aims to keep both mothers and their babies healthy and safe.

The STARS + maternal Attachment Biobehavioral Catchup (mABC) home visiting model offers additional support, focusing on positive parenting and caring for babies exposed to substances. However, specific safety data from previous studies is not yet available.

The trial is in an early phase, primarily assessing how well participants handle the treatment rather than detailed safety information. While the program is designed to be caring and supportive, specific safety data is still being collected. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STARS + mABC treatment for substance use during pregnancy because it combines prenatal care with a unique home visiting model called Attachment Biobehavioral Catchup (ABC). Unlike typical options that focus primarily on medical or counseling interventions, this approach adds personalized in-home support to strengthen the bond between mother and child, which could be crucial for recovery and overall family well-being. This innovative method targets not just the medical aspects but also the emotional and behavioral facets of substance use, potentially leading to more comprehensive outcomes for both the mother and her baby.

What evidence suggests that this trial's treatments could be effective for substance use during pregnancy?

Research has shown that the STAR Prenatal Clinic provides comprehensive prenatal care, including support services like peer support and recovery specialists. This approach has proven effective in helping women have healthier babies. Participants in this trial may receive care through the STARs Only program, which emphasizes these prenatal services. Studies of similar programs, such as those in Australia, have demonstrated significant improvements in addiction issues, with 80% of participants achieving periods of sobriety. Another group in this trial will receive the STARS + maternal Attachment Biobehavioral Catchup (mABC) home visiting model, which includes support from licensed therapists to enhance positive parenting and address substance exposure in babies. Early results suggest that these interventions can improve the well-being and stability of families dealing with substance use. ^{1 2 3 4 5}

Who Is on the Research Team?

David Bard, PhD

Principal Investigator

OUHSC

Are You a Good Fit for This Trial?

This trial is for pregnant women in the Oklahoma City area who are dealing with substance abuse during pregnancy, can understand English, and are eligible for services at the STAR prenatal clinic. Women must be able to read English at an 8th-grade level or higher to participate.

Inclusion Criteria

Pregnant woman with substance abuse issue occurring during pregnancy

Eligible for services at the STAR prenatal clinic

Speaks/comprehends English

Exclusion Criteria

Unable to read English at 8th grade comprehension level

Those outside of Oklahoma City metropolitan area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive prenatal care services in the STAR clinic, with some randomized to receive additional mABC home visiting services

Up to 12 months

Up to 12 home visits for mABC group

Follow-up

Participants are monitored for outcomes such as mother depressive symptoms, child development, and child welfare involvement

18 months post birth

Extension

Optional continued support and monitoring for families at risk under the Family First Prevention Services Act

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• STARS + maternal Attachment Biobehavioral Catchup home visiting model
• STARs Only

Trial Overview The STARS Project is testing two approaches: one group receives standard treatment (STARs Only), while another gets additional support through a home visiting model called mABC that focuses on caring for babies exposed to substances and enhancing parenting skills.

How Is the Trial Designed?

Group I: STARS + mABC Experimental Treatment 1 Intervention

Consenting research participant who receive prenatal care services in the STAR clinic, and are randomized to receive mABC home visiting services.

Group II: Control Group/CHOUM Only Active Control 1 Intervention

These are research participants who were eligible to receive care in the STAR clinic, but did not opt to receive that care.

Group III: STARs Only Active Control 1 Intervention

Consenting research participant who receive prenatal care services in the STAR clinic, but are not randomized to receive mABC home visiting services.

STARS + maternal Attachment Biobehavioral Catchup home visiting model is already approved in United States for the following indications:

Approved in United States as STARS Program for:

• Substance use disorder treatment for pregnant women
• Support for substance-exposed newborns

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

In a study of 196 pregnant substance users, those experiencing family discord were more likely to live with problematic substance users and reported higher rates of substance use throughout the study.

Women with family discord attended more treatment sessions in the first month, suggesting that targeted interventions for this group could improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family discord is associated with increased substance use for pregnant substance users. Denton, WH., Adinoff, BH., Lewis, D., et al.[2021]

The study involved 30 pregnant women, with a significant portion (33%) under 19 years old, and found that counseling and supportive interventions led to a decrease in substance abuse during pregnancy.

Mothers who received interventions had fewer perinatal complications and better parent-infant interaction scores compared to the control group, highlighting the effectiveness of home visitor programs in promoting healthier pregnancies and improving child development outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health nursing visits for at-risk women and infants. Starn, JR.[2004]

The MOMS program significantly increased the likelihood of pregnant women with opioid use disorder (OUD) receiving medication-assisted treatment (MAT) and behavioral health counseling throughout their pregnancy, with odds ratios indicating strong improvements across all trimesters.

Participation in the MOMS program was associated with better retention in MAT during the postpartum period and a marginal reduction in the out-of-home placement of infants, highlighting the program's potential to support both maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A statewide quality improvement (QI) initiative for better health outcomes and family stability among pregnant women with opioid use disorder (OUD) and their infants. Crane, D., Marcotte, M., Applegate, M., et al.[2020]

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]

A pilot randomized trial involving 21 mothers in residential substance-abuse treatment showed that those who participated in the attachment-based parenting program exhibited more supportive parenting behaviors compared to the control group.

The intervention consisted of 10 home-based sessions of the Attachment and Biobehavioral Catch-up (ABC) program, indicating that such programs can be feasibly integrated into substance-abuse treatment for new mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting supportive parenting in new mothers with substance-use problems: a pilot randomized trial of residential treatment plus an attachment-based parenting program. Berlin, LJ., Shanahan, M., Appleyard Carmody, K.[2018]

The Early Start Program effectively addresses maternal substance abuse by providing comprehensive support, including screening, early intervention, and ongoing counseling, directly within the prenatal clinic setting.

The program's integration with a perinatal health services research unit enhances its effectiveness and offers a model that can be adapted for use in other managed care environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Start: an obstetric clinic-based, perinatal substance abuse intervention program. Armstrong, MA., Lieberman, L., Carpenter, DM., et al.[2019]

Project Nurture, an integrated care model in Portland, Oregon, significantly reduced child maltreatment and foster care placements among opioid-dependent women enrolled in Medicaid, highlighting its effectiveness in improving child welfare outcomes.

The program also led to increased prenatal visits and longer hospital stays for mothers, suggesting that coordinated care can enhance maternal health and support during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project Nurture Integrates Care And Services To Improve Outcomes For Opioid-Dependent Mothers And Their Children. John McConnell, K., Kaufman, MR., Grunditz, JI., et al.[2021]

In a 12-month study involving 57 mothers with substance use disorders and their infants, both groups showed improvements in social-emotional functioning, indicating that relationship-based case management and community services can positively impact mother-child relationships.

The study found that the number of community services received was a significant predictor of improved social-emotional functioning, especially for families facing more adverse circumstances, highlighting the importance of comprehensive support for these mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and moderators of improved social-emotional functioning in mothers with substance use disorders and their young children enrolled in a relationship-based case management program. Hildebrandt, UC., Graham, JC., Grant, TM.[2021]

A study of over 60,000 children born between 1983 and 2007 in Western Australia found that more than half of non-Indigenous and 84% of Indigenous children exposed to maternal alcohol-use disorder experienced at least one negative outcome, indicating a significant impact on child health and development.

Children whose mothers were diagnosed with an alcohol-use disorder during pregnancy had the highest risk of negative outcomes, with odds ratios of 4.65 for non-Indigenous and 5.18 for Indigenous children, emphasizing the critical need for prevention and intervention strategies for at-risk mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal Alcohol-Use Disorder and Child Outcomes. O'Leary, C., Lawrence, D., Hafekost, K., et al.[2021]

A study involving 41 low-income mothers and their 12-month-old children found that both substance-exposed and non-exposed groups had low levels of attachment security and quality of caregiving, indicating that substance exposure alone may not be the main factor affecting attachment outcomes.

The research revealed that the quality of caregiving was a significant predictor of attachment security, suggesting that improving maternal sensitivity and involvement could benefit both substance-exposed and non-exposed children facing social risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attachment in substance-exposed toddlers: The role of caregiving and exposure. Bergin, C., McCollough, P.[2019]

The Washington State Parent-Child Assistance Program, which supports at-risk mothers who abuse alcohol and drugs, showed significant improvements in outcomes for 216 women over a three-year period, particularly in areas like alcohol/drug treatment completion and subsequent deliveries without exposure to substances.

Results from the program's original demonstration (1991-1995) were not only maintained but improved in later replications (1996-2003), indicating the effectiveness of this community-based intervention model across different sites and suggesting that public policies may have positively influenced these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing alcohol and drug exposed births in Washington state: intervention findings from three parent-child assistance program sites. Grant, TM., Ernst, CC., Streissguth, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04459000

Study Details | NCT04459000 | Substance Use Treatment ... This study is evaluating a randomized clinical trial and a quasi-experimental observational study combined. Pregnant women with substance abuse issues are ...

2. withpower.com withpower.com/trial/phase-substance-related-disorders-11-2020-c70e0

STARS + Maternal Support for Substance Use During ... What data supports the effectiveness of the STARS + maternal Attachment Biobehavioral Catchup home visiting model treatment for substance use during pregnancy?

3. childandfamilypolicy.duke.edu childandfamilypolicy.duke.edu/blog/research-item/substance-use-treatment-access-to-resources-study/

Substance Use Treatment & Access to Resources Study The STARS program will focus on women and babies residing in Oklahoma County at the time of birth who are at risk of removal and will follow the family when ...

4. oklahoma.gov oklahoma.gov/odmhsas/treatment/adult-family-treatment-services/star-program.html

STAR Prenatal Clinic - Oklahoma.gov STAR Prenatal Clinic at the OU Health Science Center in Oklahoma City provides comprehensive specialized prenatal care for pregnant persons with substance use ...

5. oklahoma.gov oklahoma.gov/odmhsas/about/public-information/press-releases-and-other-news/2023/odmhsas--star-clinic-helping-women-deliver-healthy-babies--achie.html

ODMHSAS, STAR Clinic Helping Women Deliver Healthy ... The STAR Prenatal Clinic emphasizes a comprehensive approach to prenatal care that includes supportive psychosocial services, peer support recovery specialists.