NCT07569393

Brief Summary

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:

  1. 1.Participants will show high rates of fidelity, acceptability, and satisfaction with the intervention
  2. 2.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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Apr 2026Oct 2026

Study Start

First participant enrolled

April 1, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 21, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Mental healthGroup interventionSpanish

Outcome Measures

Primary Outcomes (5)

  • Maternal Depression

    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

    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

    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

    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

    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

Study Arms (1)

Mama Empoderada

EXPERIMENTAL

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.

Behavioral: Mama Empoderada

Interventions

Mama EmpoderadaBEHAVIORAL

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.

Mama Empoderada

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants who are high risk for suicide based on Columbia Suicide Rating Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Cecilia Martinez-Torteya, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Psychiatry

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 6, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations