Proud of Baby and Me for Maternal Substance Abuse

MK
Overseen ByMollee K Steely Smith, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Arkansas
Must be taking: Opioid use disorder medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support new mothers dealing with opioid use disorder (OUD) by helping them continue their medication after childbirth. It focuses on the Proud of Baby and Me program, which offers parenting tips and support to reduce stress and promote healthy parenting. The trial seeks new mothers who are between 28 weeks pregnant and 12 months postpartum, speak English, and are already receiving medication for OUD in an outpatient setting. As an unphased trial, this study provides a unique opportunity for participants to access supportive resources and contribute to valuable research on maternal health and OUD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to be on medications for opioid use disorder.

What prior data suggests that the "Proud of Baby and Me" program is safe for postpartum women with opioid use disorder?

Research has shown that the "Proud of Baby and Me" program was adapted from a parenting education initiative originally used in the WIC program in Arkansas. This program helps new parents learn about infant care, safe sleep, and other parenting skills, and it was well-received in its original setting.

The current study tests this program in outpatient clinics for women with opioid use disorder (OUD) who take medications like methadone or buprenorphine. These medications are standard treatments and are generally considered safe for managing OUD.

No specific reports of negative effects from the "Proud of Baby and Me" program itself have emerged. The program focuses on providing support and education, not on introducing new medications or treatments. This suggests the program is likely well-tolerated, as it builds on existing, successful parenting support strategies.12345

Why are researchers excited about this trial?

Researchers are excited about "Proud of Baby and Me" because it adapts a successful parenting education program specifically for mothers undergoing treatment for opioid use disorder. Unlike standard parenting resources, which may not address the unique challenges faced by these mothers, this program offers tailored support in outpatient substance use treatment settings. It focuses on promoting child well-being and reducing parental stress through individualized, evidence-based sessions. By integrating parenting education with substance use treatment, it aims to enhance both maternal and infant health outcomes, offering a holistic approach that could fill a crucial gap in current care options.

What evidence suggests that the "Proud of Baby and Me" program is effective for postpartum women with opioid use disorder?

Research shows that the "Proud of Baby and Me" program was created to help new parents by reducing stress and preventing child abuse and neglect. The program offers parenting education on topics like safe sleep practices and responding to a baby's cries. Early evidence suggests that positive parenting support can improve parenting skills and reduce stress in parents dealing with opioid use disorder (OUD). This trial will evaluate the effectiveness of the "Proud of Baby and Me" program specifically for new mothers taking medication for OUD. Although limited data exists on the program's effectiveness for these mothers, combining parenting support with substance use treatment appears promising. This approach aims to help mothers stay on their treatment plan and care better for their babies.13567

Who Is on the Research Team?

MK

Mollee K Steely Smith, PhD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

This trial is for early postpartum mothers receiving outpatient treatment for opioid use disorder (OUD). They are looking to improve their parenting skills and maintain their medication-assisted recovery. Specific eligibility criteria have not been provided, but typically participants would need to meet certain health and lifestyle standards.

Inclusion Criteria

Understand and speak English
Able to give informed consent
Between 28 weeks gestation and up to 12 months postpartum
See 2 more

Exclusion Criteria

Unwilling to consent
I am less than 28 weeks pregnant or more than 12 months postpartum.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Baby & Me parenting education program, delivered individually via monthly 30-minute sessions over seven months

7 months
Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for program utilization, acceptability, client satisfaction, depressive symptoms, parental stress, parenting confidence, and drug use and cravings

Up to 12 months after delivery

What Are the Treatments Tested in This Trial?

Interventions

  • Proud of Baby and Me
Trial Overview 'Proud of Baby and Me' is an intervention being tested in this study. It aims to support new mothers in overcoming challenges such as substance abuse relapse, mental health issues, infant care stressors, and the stigma associated with OUD during the vulnerable postpartum period.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Baby & MeExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials
500
Recruited
153,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

Citations

Top Substance Abuse Clinical Trials | PowerAmong these, the investigators have identified four key outcomes: (1) the mother is on a reliable method of birth control, (2) abstinence for six months, (3) ...
The MATernaL and Infant NetworK to Understand ...Between 1999 and 2014, the diagnosis of OUD (also referred to as opioid addiction or opioid dependence) quadrupled from 1.5 to 6.5 per 1000 ...
Parental Opioid Misuse and Adolescent-Reported Positive ...The present research examines whether parental opioid misuse interferes with positive parenting behaviors, which are indicators of parental ...
DRUG FREE MOMS + BABIES PROJECTThe goal of the DFMB Project is to develop, evaluate, document, and replicate programs that support healthy baby outcomes by providing prevention, early ...
Effects of Opioid Use on Maternal and Fetal Health & ...Access to prenatal care specifically for PWUD can improve maternal and fetal health outcomes. Maternal opioid use negatively effects on fetal ...
Care for Pregnant and Postpartum Patients with Substance ...The Care for Pregnant and Postpartum Patients with Substance Use Disorder Patient Safety Bundle was revised in 2021 to incorporate respectful care concepts, ...
Perinatal healthcare experiences of pregnant and ...Early identification of substance use in pregnancy can offer improved outcomes for both parent and child, including referrals to substance use ...
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