Substance Use TreatmentNCT07071766
Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment
A study testing Proud of Baby and Me in people with Substance Use Treatment and Perinatal Substance Use, run by University of Arkansas at 1 site in United States.
Trial summary
Drug overdose is a leading cause of death among postpartum women and opioid-related mortality is 4 times higher in the postpartum period when compared to the third trimester of pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Use Treatment, Perinatal Substance Use, Parenting
- What is being tested?
- Proud of Baby and Me
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Understand and speak English
- Able to give informed consent
- Receiving medications for opioid use disorder in the outpatient clinical setting
- Between 28 weeks gestation and up to 12 months postpartum
Who cannot join
- Unwilling to consent
- Before 28 weeks gestation and beyond 12 months postpartum at enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Mollee K Steely Smith, PhD, 501-320-7271, mksteelysmith@uams.edu
About this study
Official title: Adaptation and Implementation of an Evidence-Based Parenting Intervention for Postpartum Women Receiving Medications for Opioid Use Disorder
Drug overdose is a leading cause of death among postpartum women and opioid-related mortality is 4 times higher in the postpartum period when compared to the third trimester of pregnancy. Medications for opioid use disorder (MOUD; e.g., methadone or buprenorphine) are the recommended standard of care for perinatal women with OUD. Studies indicate that 50-60% of perinatal women with OUD initiate medications during pregnancy; however, over half will prematurely discontinue treatment within the first six months of childbirth due to stressors experienced in the postpartum period. Common stressors that contribute to MOUD treatment discontinuation in this population are return to opioid use, mental health symptoms including depression, parenting-related stressors such as challenges in infant care and bonding, Neonatal Abstinence Syndrome (NAS), child welfare involvement, and feelings of guilt, shame, and stigma. Thus, there is an urgent need to develop effective, recovery-oriented support interventions that promote the initiation and continuity of MOUD treatment in the postpartum period. The current study utilizes community-engaged research methods to identify and prioritize the early parenting-related needs of postpartum women receiving MOUD to inform the adaptation and implementation of an evidence-based parenting intervention for this population receiving outpatient treatment for opioid use disorder.
- Conditions
- Substance Use Treatment, Perinatal Substance Use, Parenting
- Being tested
- Proud of Baby and Me
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proud of Baby and MeBehavioural
The original Baby \& Me curricula was adapted to be delivered in outpatient substance use treatment settings to newly postpartum women receiving medications for opioid use disorder (MOUD) for this study.
| Study group | Role | What they receive |
|---|---|---|
| Baby & Me | Experimental | Baby \& Me is a manualized parenting education program originally developed for the use in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) offices in Arkansas. The program is designed to promote child well-being, reduce parental stress, and prevent child abuse and neglect among WIC recipients who are in their third trimester of pregnancy or have a newborn up to one-month of age. The program is delivered individually to new parents and caregivers via monthly 30-minute sessions over seven months and aims to ensure that new parents and caregivers receive evidence-based parenting education relevant to safe sleep practices, responding to infant cries, maternal mood and self-care, home safety, and developmental milestones. The original Baby \& Me curricula was adapted to be delivered in outpatient substance use treatment settings to newly postpartum women receiving medications for opioid use disorder (MOUD) for this study. Receives: Behavioral: Proud of Baby and Me |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Utilization
% of eligible women who choose to enroll in Baby \& Me
Measured: Up to 12 months after delivery
Program Acceptability
Self-report ratings of the acceptability of Proud of Baby \& Me
Measured: Up to 12 months after delivery
Client Satisfaction
Self-reported scores on the Client Satisfaction Questionnaire
Measured: Up to 12 months after delivery
Secondary outcomes (3)
Depressive Symptoms
Self-report scores of the Edinburg Postnatal Depression Scale
Measured: Up to 12 months after delivery
Parental Stress
Self-reported scores on the Parenting Stress Index - Short Form
Measured: Up to 12 months after delivery
Parenting Confidence
Self-reported scores of perceived parenting confidence on the Karitane Parenting Confidence Scale
Measured: Up to 12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Sep 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use TreatmentStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Mollee K Steely Smith, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071766
- Sponsor's protocol ID
- 287138
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Implementation of an Evidence-Based Parenting Intervention for Postpartum Women Receiving Medications for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT07071766
- Acronym / sponsor ID
- 287138
- Conditions
- Substance Use Treatment, Perinatal Substance Use, Parenting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drug overdose is a leading cause of death among postpartum women and opioid-related mortality is 4 times higher in the postpartum period when compared to the third trimester of pregnancy. Medications for opioid use disorder (MOUD; e.g., methadone or buprenorphine) are the recommended standard of care for perinatal women with OUD. Studies indicate that 50-60% of perinatal women with OUD initiate medications during pregnancy; however, over half will prematurely discontinue treatment within the first six months of childbirth due to stressors experienced in the postpartum period. Common stressors that contribute to MOUD treatment discontinuation in this population are return to opioid use, mental health symptoms including depression, parenting-related stressors such as challenges in infant care and bonding, Neonatal Abstinence Syndrome (NAS), child welfare involvement, and feelings of guilt, shame, and stigma. Thus, there is an urgent need to develop effective, recovery-oriented support interventions that promote the initiation and continuity of MOUD treatment in the postpartum period. The current study utilizes community-engaged research methods to identify and prioritize the early parenting-related needs of postpartum women receiving MOUD to inform the adaptation and implementation of an evidence-based parenting intervention for this population receiving outpatient treatment for opioid use disorder.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baby & Me | Experimental | Behavioral: Proud of Baby and MeBaby \& Me is a manualized parenting education program originally developed for the use in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) offices in Arkansas. The program is designed to promote child well-being, reduce parental stress, and prevent child abuse and neglect among WIC recipients who are in their third trimester of pregnancy or have a newborn up to one-month of age. The program is delivered individually to new parents and caregivers via monthly 30-minute sessions over seven months and aims to ensure that new parents and caregivers receive evidence-based parenting education relevant to safe sleep practices, responding to infant cries, maternal mood and self-care, home safety, and developmental milestones. The original Baby \& Me curricula was adapted to be delivered in outpatient substance use treatment settings to newly postpartum women receiving medications for opioid use disorder (MOUD) for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Understand and speak English
- Able to give informed consent
- Receiving medications for opioid use disorder in the outpatient clinical setting
- Between 28 weeks gestation and up to 12 months postpartum
Key exclusion criteria (2 listed)
- Unwilling to consent
- Before 28 weeks gestation and beyond 12 months postpartum at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proud of Baby and MeThe original Baby \& Me curricula was adapted to be delivered in outpatient substance use treatment settings to newly postpartum women receiving medications for opioid use disorder (MOUD) for this study. | Behavioural | Baby & Me |
Primary outcome
Program Utilization
Time frame: Up to 12 months after delivery
% of eligible women who choose to enroll in Baby \& Me
Program Acceptability
Time frame: Up to 12 months after delivery
Self-report ratings of the acceptability of Proud of Baby \& Me
Client Satisfaction
Time frame: Up to 12 months after delivery
Self-reported scores on the Client Satisfaction Questionnaire
3 secondary outcomes
Depressive Symptoms
Time frame: Up to 12 months after delivery
Parental Stress
Time frame: Up to 12 months after delivery
Parenting Confidence
Time frame: Up to 12 months after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mollee K Steely Smith, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proud of Baby and Me in people with Substance Use Treatment and Perinatal Substance Use, run by University of Arkansas 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mollee K Steely Smith, PhD (501-526-8174, mksteelysmith@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Utilization (time frame: Up to 12 months after delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.