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

Trial Summary

What is the purpose of this trial?

This study is evaluating a randomized clinical trial and a quasi-experimental observational study combined. Pregnant women with substance abuse issues are referred to the Substance Use Treatment and Recovery (STAR) prenatal clinic, and those who consent to participate in the study will be randomized to the STAR + maternal Attachment Biobehavioral Catchup (mABC) home visiting model or to the STAR only treatment group. Those who opt out of receiving prenatal care at STAR will be recruited as a control group for the QED portion. Those randomized to STAR + mABC will receive additional supports from a licensed therapist, including up to 12 home visits focused on substance exposed babies and positive parenting.

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.

What data supports the effectiveness of the STARS + maternal Attachment Biobehavioral Catchup home visiting model treatment for substance use during pregnancy?

Research shows that home visitation programs, like the Parent-Child Assistance Program, help at-risk mothers reduce substance use and improve outcomes for their children. Additionally, attachment-based parenting programs have been shown to enhance supportive parenting behaviors in mothers with substance-use problems. ^{1 2 3 4 5}

Is the STARS + Maternal Support for Substance Use During Pregnancy treatment safe for humans?

The research articles provided do not contain specific safety data for the STARS + Maternal Support for Substance Use During Pregnancy treatment. However, they discuss related programs that integrate maternity care and substance use treatment, which have shown positive outcomes in terms of reducing child maltreatment and improving social-emotional functioning, suggesting a focus on safety and well-being. ^{6 7 8 9 10}

How is the STARS + Maternal Support treatment different from other treatments for substance use during pregnancy?

The STARS + Maternal Support treatment is unique because it combines the STARS Program, which focuses on substance use treatment and recovery, with the maternal Attachment Biobehavioral Catchup (mABC) home visiting model. This approach not only addresses substance use but also enhances maternal sensitivity and involvement, which are crucial for improving attachment and developmental outcomes in children. ^{3 4 6 9 11}

Research Team

David Bard, PhD

Principal Investigator

OUHSC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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 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]

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]

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 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 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]

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]

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]

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

Promoting supportive parenting in new mothers with substance-use problems: a pilot randomized trial of residential treatment plus an attachment-based parenting program. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Preventing alcohol and drug exposed births in Washington state: intervention findings from three parent-child assistance program sites. [2019]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Family discord is associated with increased substance use for pregnant substance users. [2021]

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

Early Start: an obstetric clinic-based, perinatal substance abuse intervention program. [2019]

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

Project Nurture Integrates Care And Services To Improve Outcomes For Opioid-Dependent Mothers And Their Children. [2021]

8. United States 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. [2021]

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

Attachment in substance-exposed toddlers: The role of caregiving and exposure. [2019]

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

Maternal Alcohol-Use Disorder and Child Outcomes. [2021]

11. United States 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. [2020]