- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07485036
Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms (MOMS-AD)
Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms (MOMS-AD Pilot Study)
This study aims to learn about depression and alcohol use in postpartum mothers and whether an intervention based on contingency management and problem-solving therapy (CM-PST) can help reduce these symptoms. The main questions it seeks to answer are:
- How do new mothers fare with depressive symptoms and alcohol use in the first 12 months after giving birth?
- Will a CM-PST intervention reduce depressive symptoms and alcohol use frequency among new mothers?
- Is a CM-PST intervention practical for new mothers?
The researchers will recruit approximately 30 new mothers and randomly select half to attend a 6-week CM-PST intervention. They will compare those who received the intervention versus those who did not to see if there are any differences in their depressive symptoms and alcohol usage.
Participants will:
- Complete 4 remote intervention sessions over 6 weeks
- Conduct at-home urine drug tests 2x per week during the 6-week intervention
- Answer online surveys about their mental health and alcohol use
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hagar Hallihan, PhD, RN
- Phone Number: 312-413-5361
- Email: hhalli2@uic.edu
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois Hospital and Health Sciences System, University of Illinois College of Medicine
-
Contact:
- Hagar Hallihan, PhD, RN
- Phone Number: 312-413-5361
- Email: hhalli2@uic.edu
-
Principal Investigator:
- Hagar Hallihan, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Biologically female
- Age ≥18 years
- Within 12 months postpartum
- Able to provide informed consent
Exclusion Criteria:
- Serious medical or psychiatric conditions requiring hospitalization
- Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychiatric disorder
- Current use of psychoactive drugs, medication to treat problematic alcohol use, or depression
- Participation in past 6 months in problematic alcohol use or substance use treatment
- Unable to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Usual Care Control Group
|
Participants randomized to the usual care condition will continue to receive standard postpartum care from their obstetrician-gynecologist, consistent with routine clinical practice.
No additional psychological intervention will be provided as part of the study.
|
|
Experimental: Contingency Management & Problem Solving Therapy (CM-PST) Intervention Group
Receives 4 remote sessions of CM-PST therapy over 6 weeks while conducting at home urine drug tests 2x weekly.
|
A 6-week online CM-PST course delivered through video conferencing calls consisting of 4 educational sessions, combined with 2x weekly at-home drug testing to monitor the reduction in alcohol use and reduced depression symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in postpartum depression symptoms
Time Frame: Screening, Baseline, 3 months
|
Participants will take the Edinburgh Postnatal Depression Scale (EPDS) at screening, baseline and at 3 months to assess changes in mental health and depressive symptoms.
This is reported on a scale of 0-30; a higher score indicates a higher likelihood of postpartum depression.
|
Screening, Baseline, 3 months
|
|
Alcohol use test results
Time Frame: Baseline, Weekly, 3 months
|
Participants' alcohol use will be monitored and assessed with urine drug tests at baseline, 2x weekly throughout the duration of the 6-week intervention, and at 3 months.
|
Baseline, Weekly, 3 months
|
|
Change in alcohol use screening status
Time Frame: Screening, Baseline, 3 months
|
Participants will take the Alcohol Use Disorders Identification Test (AUDIT) at the time of screening, baseline and at 3 months.
This is reported on a scale of 0-40; a higher score indicates a higher likelihood of moderate to severe alcohol use.
|
Screening, Baseline, 3 months
|
|
Change in alcohol-related negative consequences
Time Frame: Baseline, 3 months
|
Participants will take the Rutgers Alcohol Problems Index (RAPI) at baseline and at 3 months to assess changes in problems related to alcohol use.
This is reported on a scale of 0-72; a higher score indicates a higher likelihood of alcohol-related negative consequences in everyday life.
|
Baseline, 3 months
|
|
Change in alcohol use
Time Frame: Baseline, 3 months
|
Participants will take the Timeline Follow Back (TLFB) questionnaire at baseline and at 3 months to assess changes in alcohol use.
|
Baseline, 3 months
|
|
Change in reasons for drinking
Time Frame: Baseline, 3 months
|
Participants will take the Drinking Motive Questionnaire-Revised (DMQ-R) at baseline and at 3 months to assess changes in alcohol use motivations.
This is reported on a scale of 20-100; a higher score indicates stronger motivations for alcohol use.
|
Baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of intervention
Time Frame: 3 months
|
Participants will complete a 10-minute interview at the end of the intervention to assess their sentiments towards CM-PST and take the Client Counseling Satisfaction Scale (CCSS).
This is reported on a five-point Likert scale of 6-30, and includes an open-ended question about suggestions for future interventions.
A higher score indicates a higher likelihood of participant satisfaction.
|
3 months
|
|
Feasibility of intervention via adherence
Time Frame: 3 months
|
Participant adherence will be assessed by monitoring and documenting attendance for each intervention session and completion of urine alcohol screening tests.
|
3 months
|
|
Feasibility of intervention via retention
Time Frame: 3 months
|
Participant retention will be assessed by monitoring and calculating the proportion of the study sample retained by the end of the intervention.
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-0112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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