- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07569393
Mama Empoderada: Parenting and Mental Health Intervention
April 28, 2026 updated by: Cecilia Martinez Torteya, University of Michigan
Mama Empoderada: A Culturally and Linguistically Responsive Preventative Intervention for Spanish Speaking Mothers and Their Young Children
This project focuses on the implementation and preliminary evaluation of Mama Empoderada, a brief 12-week group intervention that is based on a parenting program (Mom Power).
The researcher's hypotheses are that:
- Participants will show high rates of fidelity, acceptability, and satisfaction with the intervention
- Participants will experience decreases in depression, anxiety, isolation, parenting stress, and parent-child interaction problems from pre- to post-intervention, as well as increases in parenting sense of competence.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The study team is from the University of Michigan.
The intervention will take place at La Casa Amiga in Pontiac, Michigan.
Study Type
Interventional
Enrollment (Estimated)
20
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: Olivia Oates
- Phone Number: 248-804-2846
- Email: oolivia@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
Contact:
- Olivia Oates
- Phone Number: 248-804-2846
- Email: oolivia@med.umich.edu
-
Principal Investigator:
- Cecelia Martinez-Torteya, 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
Yes
Description
Inclusion Criteria:
- Identifies as a mother of a child ages 6 or younger;
- Spanish-speaker;
- available and interested in participating in an in-person or virtual maternal wellbeing and parenting group intervention at La Casa Amiga. Eligibility criteria will be confirmed by each participant through a brief online screening and a phone call with research staff.
Exclusion Criteria:
- Participants who are high risk for suicide based on Columbia Suicide Rating Scale
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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mama Empoderada
20 Spanish-speaking mothers of young children (i.e., ages 0 to 6).
Given the population served by recruiting partners, it is expected that many of the women will experience economic oppression and racism/prejudice.
|
Mama Empoderada focuses on the five pillars of the original Mom Power intervention, and evidence-based treatment that enhances maternal mental health, parenting, and the mother-child relationship.
The pillars are: psychoeducation on attachment-based parenting, supporting mother-child relationships, self-care, enhancing social support, and connection to community resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Depression
Time Frame: Baseline, up to 21 days post-intervention
|
9 items rated on a 4-point frequency scale (Sum score range = 0 to 27; higher scores indicate more depressive symptoms)
|
Baseline, up to 21 days post-intervention
|
|
Maternal Anxiety
Time Frame: Baseline, up to 21 days post-intervention
|
7 items rated on a 4-point frequency scale (Sum score range = 0 to 21; higher scores indicate more anxiety symptoms)
|
Baseline, up to 21 days post-intervention
|
|
Maternal Isolation
Time Frame: Baseline, up to 21 days post-intervention
|
Assessed using the UCLA-3 Loneliness Scale 3 items rated on a 3-point frequency scale (Sum score range = 1 to 9; higher scores indicate more loneliness)
|
Baseline, up to 21 days post-intervention
|
|
Maternal Parenting Stress
Time Frame: Baseline, up to 21 days post-intervention
|
Assessed using the Parenting Stress Inventory - Short Form- 12-item Parental Distress subscale and 12-item Parent-Child Dysfunctional Interaction subscale, rated on a 5-point agreement scale (Range = 12 - 60; higher scores indicate more distress or dysfunction)
|
Baseline, up to 21 days post-intervention
|
|
Mother Child Interaction Problems
Time Frame: Baseline, up to 21 days post-intervention
|
Assessed using the Parenting Sense of Competence Scale-16 items rated on a 6-point agreement scale (Sum score range = 16 to 96; higher scores indicate higher parenting self-efficacy)
|
Baseline, up to 21 days post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cecilia Martinez-Torteya, PhD, University of Michigan
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)
April 1, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
April 21, 2026
First Submitted That Met QC Criteria
April 28, 2026
First Posted (Actual)
May 6, 2026
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00289106
- 20250010-00 (Other Identifier: Michigan Department of Health and Human Services)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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