Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms (MOMS-AD)

May 5, 2026 updated by: University of Illinois at Chicago

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:

  1. How do new mothers fare with depressive symptoms and alcohol use in the first 12 months after giving birth?
  2. Will a CM-PST intervention reduce depressive symptoms and alcohol use frequency among new mothers?
  3. 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

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hagar Hallihan, PhD, RN
  • Phone Number: 312-413-5361
  • Email: hhalli2@uic.edu

Study Locations

    • Illinois
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will adhere to the NIH Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources issued December 23, 1999. Data from this research will be shared and the results of this research will be made available via publication in scientific journals and through scientific meetings where our findings are reported. Publication of data shall occur during the project, if appropriate, or at the end of the project, consistent with typical scientific practices. All publications will be made publicly available consistent with NIH policies.

IPD Sharing Time Frame

After analyzing data.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Contingency Management

Clinical Trials on Contingency Management & Problem Solving Therapy

Subscribe