InterventionalNCT06468046
Mama Empoderada: Adapting a Novel Mental Health Prevention Intervention for Migrant Mothers With Young Children
A study testing Mama Empoderada [Mom Power] in people with Interventional, run by San Diego State University at 1 site in Mexico.
Trial summary
This pilot randomized controlled trial will test a theory-based, trauma-informed, and culturally-tailored intervention [Mama Empoderada' (Mom Power)] to promote mental health and positive parenting among migrant mothers with young children. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Interventional
- What is being tested?
- Mama Empoderada [Mom Power]
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 21 Oct 2024to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identify as a mother to at least one accompanying child <6 years of age
- At least 18 years old
- Migrated to Tijuana from a Latin American country other than Mexico, or born in Mexico and internally displaced
- Able to provide informed consent
- Screen below cut-offs for major depression and anxiety disorder
- Able to speak Spanish
- Available to participate in full duration of 'Mama Empoderada'
Who cannot join
- Not a mother or only accompanied by older children (> age 6)
- Less than 18 years of age
- Migrated to Tijuana from region outside of Latin America or non-migrant
- Unable to provide informed consent
- Screen above cut-offs for major depression and anxiety disorders
- Unable to speak Spanish
- Unable to participate in full intervention (either control or intervention group).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mama Empoderada: Adapting a Novel Mental Health Prevention Intervention for Migrant Mothers With Young Children in a Humanitarian Setting
This pilot randomized controlled trial will test a theory-based, trauma-informed, and culturally-tailored intervention [Mama Empoderada' (Mom Power)] to promote mental health and positive parenting among migrant mothers with young children.
Read the detailed description
The goal of this randomized controlled trial is to adapt and pilot-test a novel mental health prevention intervention for migrant mothers with young children in a humanitarian setting.
This pilot trial will adapt 'Mama Empoderada' [Mom Power] - a theory-based, trauma-informed, culturally-tailored group intervention to promote mental health and positive parenting among mothers with young children (0-5 years) for the first time. Aims are to:
- Conduct a pilot study of the adapted intervention to determine acceptability and estimate effect sizes on symptoms of depression, anxiety, and parenting stress; and
- Explore which theory-based mechanisms of action predict changes in symptoms of depression, anxiety, and parenting stress, and identify factors associated with differential intervention response.
The intervention group will receive trauma-informed group and individual sessions on parenting, linkage to resources (e.g., food, shelter), social support, and resilience. The control group will receive standard of care programming.
Both groups will complete baseline and exit surveys, as well as follow-up surveys at 2-, 4- and 6- months post-intervention.
- Conditions
- Interventional
- Being tested
- Mama Empoderada [Mom Power]
- Keywords
- parenting intervention, mental health, migrant mothers
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mama Empoderada [Mom Power]Behavioural
'Mamá Empoderada' [Mom Power] is a theory-based, trauma-informed group intervention to promote mental health and positive parenting among mothers with young children (0-5 years). It has been adapted for migrant mothers, and will conduct a pilot randomized controlled trial (RCT) of the intervention with migrant mothers with young children (MMC). The intervention group (IG) will receive 10 group and 3 individual sessions addressing attachment theory, hands-on parenting skills, linkage to resources (e.g., food, shelter), social support, and self-care and resilience.
| Study group | Role | What they receive |
|---|---|---|
| Mama Empoderada (Mom Power) | Experimental | Behavioral: The intervention group will receive the Mama Empoderada intervention, which is a theory- based, trauma-informed, culturally tailored group intervention to promote mental health and positive parenting outcomes among trauma-exposed mothers with young children (0-5 years). Intervention participants will receive 10 group and 3 individual sessions addressing parenting, active linkage to resources (e.g., food, shelter, migration), social support, and resilience. Receives: Behavioral: Mama Empoderada [Mom Power] |
| Standard of care | No intervention | The control group will receive standard of care programming available locally, including referrals to drop-in migrant and family supports, childcare, and referrals to reproductive, mental health, and other services. Control group participants will have the opportunity to participate in the full intervention following completion of the intervention and all questionnaires by the intervention group (post 6-month visit). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms (Patient Health Questionnaire [PHQ]-9)
Survey of Depression symptoms (PHQ-9), scores range from 1-27 with higher scores indicating more severe depression
Measured: Baseline, post-intervention (Approximately 6-weeks after baseline), and post-intervention follow-ups (2-months, 4-months, and 6-months post-intervention)
Anxiety symptoms (General Anxiety Disorder [GAD]-7)
Survey of Anxiety symptoms (GAD-7), scores range from 0-21, with higher scores indicating higher levels of anxiety.
Measured: baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)
Parental Stress Scale
Survey of Parental Stress, Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.
Measured: baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start21 Oct 2024
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InterventionalStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The pilot randomized controlled trial (RCT) of the adapted 'Mama Empoderada' intervention with Migrant Mothers will include N=100 \[N(treatment)=50; N(control)=50\] (Aims 2-3). The intervention group (IG) will participate in trauma- informed group and individual sessions addressing parenting, active linkage to resources, social support, and resilience. The control group will receive standard of care programming, including referrals to drop-in migrant and community-based supports, childcare, and referrals to reproductive, mental health, and other services. Control group participants will have the opportunity to participate in the full intervention following completion of the intervention and all questionnaires by the intervention group (post 6-month visit). Both groups will complete baseline, exit, and follow-up (2, 4, 6-months) surveys.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- El Colegio de la Frontera Norte
- Responsible party
- Sponsor
- Investigators
- Shira Goldenberg, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468046
- Sponsor's protocol ID
- HS-2023-0135
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIMH requires data that involve human subjects to be shared using the NDA (see NOT-MH-23-100). Quantitative data from this pilot trial will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the Aims as noted below.
Publications
Goldenberg SM, Ramage K, Martinez-Torteya C, Pitpitan E, Rosenblum K, Hernandez C, Alvarez M, Rangel G, Bojorquez-Chapela I. Mama Empoderada: study protocol for a pilot trial of a novel parenting and mental health prevention intervention for migrant mothers with young children at the Mexico-US border. BMJ Open. 2025 Jan 28;15(1):e094917. doi: 10.1136/bmjopen-2024-094917.
PubMed 39880445
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mama Empoderada: Adapting a Novel Mental Health Prevention Intervention for Migrant Mothers With Young Children in a Humanitarian Setting
- ClinicalTrials.gov ID
- NCT06468046
- Acronym / sponsor ID
- HS-2023-0135
- Conditions
- Interventional
- Keywords
- parenting intervention, mental health, migrant mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- El Colegio de la Frontera Norte
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 21 Jun 2024 (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.
This pilot randomized controlled trial will test a theory-based, trauma-informed, and culturally-tailored intervention [Mama Empoderada' (Mom Power)] to promote mental health and positive parenting among migrant mothers with young children.
Detailed description
The goal of this randomized controlled trial is to adapt and pilot-test a novel mental health prevention intervention for migrant mothers with young children in a humanitarian setting.
This pilot trial will adapt 'Mama Empoderada' [Mom Power] - a theory-based, trauma-informed, culturally-tailored group intervention to promote mental health and positive parenting among mothers with young children (0-5 years) for the first time. Aims are to:
- Conduct a pilot study of the adapted intervention to determine acceptability and estimate effect sizes on symptoms of depression, anxiety, and parenting stress; and
- Explore which theory-based mechanisms of action predict changes in symptoms of depression, anxiety, and parenting stress, and identify factors associated with differential intervention response.
The intervention group will receive trauma-informed group and individual sessions on parenting, linkage to resources (e.g., food, shelter), social support, and resilience. The control group will receive standard of care programming.
Both groups will complete baseline and exit surveys, as well as follow-up surveys at 2-, 4- and 6- months post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The pilot randomized controlled trial (RCT) of the adapted 'Mama Empoderada' intervention with Migrant Mothers will include N=100 [N(treatment)=50; N(control)=50] (Aims 2-3). The intervention group (IG) will participate in trauma- informed group and individual sessions addressing parenting, active linkage to resources, social support, and resilience. The control group will receive standard of care programming, including referrals to drop-in migrant and community-based supports, childcare, and referrals to reproductive, mental health, and other services. Control group participants will have the opportunity to participate in the full intervention following completion of the intervention and all questionnaires by the intervention group (post 6-month visit). Both groups will complete baseline, exit, and follow-up (2, 4, 6-months) surveys.
| Arm | Type | Receives |
|---|---|---|
| Mama Empoderada (Mom Power) | Experimental | Behavioral: Mama Empoderada [Mom Power]Behavioral: The intervention group will receive the Mama Empoderada intervention, which is a theory- based, trauma-informed, culturally tailored group intervention to promote mental health and positive parenting outcomes among trauma-exposed mothers with young children (0-5 years). Intervention participants will receive 10 group and 3 individual sessions addressing parenting, active linkage to resources (e.g., food, shelter, migration), social support, and resilience. |
| Standard of care | No intervention | –The control group will receive standard of care programming available locally, including referrals to drop-in migrant and family supports, childcare, and referrals to reproductive, mental health, and other services. Control group participants will have the opportunity to participate in the full intervention following completion of the intervention and all questionnaires by the intervention group (post 6-month visit). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-identify as a mother to at least one accompanying child <6 years of age
- At least 18 years old
- Migrated to Tijuana from a Latin American country other than Mexico, or born in Mexico and internally displaced
- Able to provide informed consent
- Screen below cut-offs for major depression and anxiety disorder
Key exclusion criteria (7 listed)
- Not a mother or only accompanied by older children (> age 6)
- Less than 18 years of age
- Migrated to Tijuana from region outside of Latin America or non-migrant
- Unable to provide informed consent
- Screen above cut-offs for major depression and anxiety disorders
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 |
|---|---|---|
| Mama Empoderada [Mom Power]'Mamá Empoderada' [Mom Power] is a theory-based, trauma-informed group intervention to promote mental health and positive parenting among mothers with young children (0-5 years). It has been adapted for migrant mothers, and will conduct a pilot randomized controlled trial (RCT) of the intervention with migrant mothers with young children (MMC). The intervention group (IG) will receive 10 group and 3 individual sessions addressing attachment theory, hands-on parenting skills, linkage to resources (e.g., food, shelter), social support, and self-care and resilience. | Behavioural | Mama Empoderada (Mom Power) |
Primary outcome
Depression symptoms (Patient Health Questionnaire [PHQ]-9)
Time frame: Baseline, post-intervention (Approximately 6-weeks after baseline), and post-intervention follow-ups (2-months, 4-months, and 6-months post-intervention)
Survey of Depression symptoms (PHQ-9), scores range from 1-27 with higher scores indicating more severe depression
Anxiety symptoms (General Anxiety Disorder [GAD]-7)
Time frame: baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)
Survey of Anxiety symptoms (GAD-7), scores range from 0-21, with higher scores indicating higher levels of anxiety.
Parental Stress Scale
Time frame: baseline, post-intervention (approximately 6-weeks after baseline), and post-intervention follow-up (2-months, 4-months, and 6-months post-intervention)
Survey of Parental Stress, Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 39880445Goldenberg SM, Ramage K, Martinez-Torteya C, Pitpitan E, Rosenblum K, Hernandez C, Alvarez M, Rangel G, Bojorquez-Chapela I. Mama Empoderada: study protocol for a pilot trial of a novel parenting and mental health prevention intervention for migrant mothers with young children at the Mexico-US border. BMJ Open. 2025 Jan 28;15(1):e094917. doi: 10.1136/bmjopen-2024-094917.
- Individual participant dataSharing planned: Yes. NIMH requires data that involve human subjects to be shared using the NDA (see NOT-MH-23-100). Quantitative data from this pilot trial will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the Aims as noted below.
Related trials for Interventional
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
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. This study is not recruiting at the moment.
Shira Goldenberg, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mama Empoderada [Mom Power] in people with Interventional, run by San Diego State University at 1 site in Mexico.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 2 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms (Patient Health Questionnaire [PHQ]-9) (time frame: Baseline, post-intervention (Approximately 6-weeks after baseline), and post-intervention follow-ups (2-months, 4-months, and 6-months post-intervention)). 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?
On the ClinicalTrials.gov record for NCT06468046, which also lists 1 linked publication.
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 2 Sep 2026.