Correspondence to Dr Shira M Goldenberg; [email protected]
STRENGTHS AND LIMITATIONS OF THIS STUDY
This study will pilot-test a newly adapted evidence-based parenting and mental health prevention intervention among migrant mothers with young children.
This study is evaluating a culturally adapted and timely mental health prevention intervention model for Latin American migrant mothers in border settings.
This intervention holds high promise for sustainability, as it is a community-based programme that could be implemented by trained staff in resource-limited settings.
As a pilot study with a small sample size, statistical power to detect rare outcomes or potential mediating or moderating effects is limited; rather, our primary goal is to generate effect size data to inform a subsequent efficacy trial.
As in other prospective studies with marginalised and mobile populations, there is high potential for loss to follow-up, which we have accounted for in our retention protocols.
Introduction
Global migration continues to rise at record-high rates, with the number of women travelling with children continuing to rise at the Mexico-US border—the busiest land border crossing globally. The border city of Tijuana, Mexico, is facing unprecedented challenges resulting from rising displacement due to violence, political conflict, lack of economic opportunity and climate change, exacerbated by migration policies that have forced many migrants to wait in Mexico for long periods under unsafe conditions. Globally and at the Mexico-US border, migrant women in transit face high risk of developing mental health problems such as depression and anxiety,1–7 driven by gendered social-structural vulnerabilities including violence, social isolation, migration uncertainty and limited access to services (eg, food, housing).2 4 8–10 Although migrants in transit who endure such conditions have high need for mental health prevention, most evidence-based approaches focus on mental health and trauma-related needs during the resettlement phase,11 12 and few are tailored to the gendered needs of migrant women in transit.11 13 Moreover, while women and children’s mental health are closely interconnected, few mental health interventions in this context address parenting needs14–16 and mental health prevention interventions that can be delivered with migrant mothers with young children who are in transit are greatly needed.12
To address the need for feasible and tailored parenting and mental health prevention interventions for migrant mothers, this study will pilot-test ‘Mamá Empoderada’—an evidence-based, trauma-informed group intervention to promote mental health and responsive parenting outcomes among mothers with young children (0–5 years). The original ‘Mom Power’ intervention was developed for marginalised mothers in the USA; has demonstrated efficacy on reducing parenting stress and symptoms of depression, anxiety and PTSD among trauma-exposed mothers in the USA;17 18 and has been implemented across nine US states. The present study represents the first adaptation and pilot of the ‘Mom Power’ intervention with migrant mothers. The intervention includes 10 group and three individual sessions addressing attachment-based parenting skills, linkage to resources (eg, food, shelter), social support, and self-care and resilience delivered over a 5-week period. This programme was recently translated from English into Spanish (‘Mamá Empoderada’). With consultation from the developers of the original intervention, we have further adapted the programme for migrant Latin American mothers through focus groups, consultations with our project’s Community Advisory Board (CAB) and pretesting of the intervention between Fall 2023 and Summer 2024. This formative work has identified very high community support and enthusiasm for the proposed intervention, notably its focus on creating a safe space to address parenting and migration stressors and build social support and parenting skills with other migrant mothers and families.
While much past research has emphasised individual-level behavioural or cultural explanations for migrant health inequities,19–21 this intervention addresses gendered parenting stressors and related social-structural vulnerabilities including social isolation and limited access to resources through a trauma-informed approach. Mom Power is theoretically underpinned by the Protective Factors Framework 22 and Trauma Theory. 23–25 The Protective Factors Framework postulates that parental resilience, social connections, knowledge of parenting and child development, and concrete support in times of need represent key protective factors that help families navigate adverse circumstances. Trauma Theory recognises that exposure to traumatic experiences has a powerful impact on stress responses, health behaviours, and outcomes and identifies trauma-informed practice as a means of promoting survivors’ well-being. Core practices include creating a safe, non-judgmental space that normalises clients’ experiences using a non-victimising approach; acknowledging the impact of trauma on challenges and coping strategies; situating challenges as shaped by social-structural factors; and empowering clients to manage their circumstances by expanding resources and support options.23 24
The aim of this study is to pilot-test a novel mental health prevention intervention for migrant mothers with young children in Tijuana, Mexico, including (a) assessing acceptability; (b) estimating effect sizes on symptoms of depression, anxiety and parenting stress; (c) exploring which theory-based mechanisms of action predict changes in symptoms of depression, anxiety and parenting stress; and (d) identifying factors associated with differential intervention response.
Methods and analysis
Study design
This pilot randomised controlled trial (RCT) is being conducted in close partnership with Al Otro Lado (AOL)—a binational non-governmental organisation that works with migrants in Tijuana, Baja California, and San Diego, California. The trial will be conducted between October 2024 and August 2026. We will enrol 100 participants (Ntreatment=50; Ncontrol=50). The study will be conducted in Tijuana, a city of 1.9 million located adjacent to San Diego. Tijuana is the busiest land border crossing in the world and a hotspot for in-transit migrants planning to cross into the USA, including asylum seekers and internally displaced persons. Services for migrants are mainly provided by a network of non-governmental organisations who operate shelters, food kitchens, clinical, mental health and other services.
Following randomisation, those allocated to the intervention group will participate in trauma-informed group and individual sessions addressing responsive parenting, active linkage to resources (eg, food, shelter), social support, and self-care and stress coping skills to nurture resilience. Those assigned to the control condition will receive standard of care programming and will have the opportunity to participate in the intervention following completion of all study visits (ie, after 7 months). Both groups will complete baseline and exit surveys, as well as follow-up surveys at 2, 4, and 6 months postintervention, with both groups receiving the same honoraria at the same intervals for their participation in the surveys. Sessions for the intervention will take place at the AOL Tijuana community office. Participants will be invited to bring their children <age six to their study visits, who will attend high-quality onsite childcare. All participants will receive active referrals to relevant health and humanitarian services.
Description of intervention and control conditions
The intervention condition to be tested is a culturally adapted version of the multicomponent ‘Mom Power’ intervention, an integrated mental health and parenting programme with intensive and active connection to resources (eg, food, safe shelter, childcare) and activities designed to strengthen social support among and between migrant mothers with young children. ‘Mamá Empoderada’ will be delivered at the AOL Tijuana community office across 10 group sessions (6–10 women/group) and three individual sessions held at the beginning, midpoint and end of the intervention. The intervention draws on a version of the manualised intervention with content collaboratively tailored by the study team and intervention developers based on parent and provider feedback on parenting education and skills, connection to resources, strengthening social support, and resilience and self-care through a trauma-informed approach. Following delivery of the intervention content and activities, each group intervention session ends with the group and facilitators sharing a nutritious and culturally appropriate meal. Due to high mobility of the study population and the unpredictable nature of migration timing, delivery of the intervention was adapted from weekly to bi-weekly (over 5 weeks) sessions. Participants are offered transportation support to encourage attendance at all in-person sessions.
Participants randomised to the control condition will receive standard of care services available through AOL and other community partners (eg, ‘know your rights’ workshops, legal aid, perinatal support programmes, humanitarian supports). Referrals and connections to these services will be provided through one group and three one-on-one sessions with control group participants (via phone or in-person) that will be held at the same intervals as the intervention group (beginning, midpoint and end of the 5-week intervention period). For ethical reasons, control group participants will be offered the opportunity to participate in the full intervention condition following the completion of the intervention and all study-related assessments (ie, after 7 months).
Eligibility criteria
Eligible participants will: (1) self-identify as a mother to at least one accompanying child <age 6; (2) have migrated to Tijuana from a Latin American country other than Mexico or born in Mexico and internally displaced; (3) be available to participate in the full duration of ‘Mamá Empoderada’; (4) e able to speak Spanish; (5) be aged >18 years old; (6) be able to provide informed consent; and (7) screen below clinical cut-offs for major depression and anxiety disorder.
Recruitment and screening
We will recruit participants via posters, outreach and direct referral by community partners. Potential participants will be invited to contact the study coordinator for additional information. Interested participants will be informed of the study’s aims and procedures and will be screened for eligibility via a brief (10 min) screener that includes brief depression (Patient Health Questionnaire-9)26 and anxiety (General Anxiety Disorder Scale (7-item))27 scales, the number and age of accompanying children, place of origin, languages spoken, and migration plans. All screened individuals who are deemed ineligible will be connected to standard of care services at AOL, as well as referrals to relevant local mental health, maternal and child health services. Eligible participants will be connected with the study coordinator for more information about study procedures, risks and benefits. Potential participants will be guided through the informed consent process prior to enrolment, which will cover the study’s purpose, design, and potential risks and benefits (see online supplemental material).
Randomisation, blinding and enrolment
After enrolment, participants will be randomised at a 1:1 ratio to the intervention or control arm on a rolling basis, using a preprogrammed block randomisation schedule. When a participant is enrolled, the study coordinator will use the list to assign them to the intervention or control condition. Once enough participants are randomised to each condition to form a group, the first session for the group will be scheduled, and participants will be notified of their dates. Using a single-blind approach, data analysts will be blinded to the intervention assignment.
Measures
Guided by our conceptual framework (figure 1), baseline, exit and follow-up survey questions were selected and adapted for the local population and cultural context from theory-based, empirically validated measures (table 1). Enrolment, baseline and exit questionnaires will be conducted at the AOL Tijuana office or on community outreach. Follow-up and baseline questionnaires are similar; fixed demographic and lifetime questions are asked at baseline only, and the follow-up recall period will be the last 2 months. The exit questionnaire will have additional questions for the intervention condition participants regarding the acceptability, feasibility, ethicality and sustainability of the intervention.28 Baseline and exit questionnaires will be administered and entered by trained study staff via Research Electronic Data Capture (REDCap) following enrolment and the final session for each group, respectively. Follow-up surveys at 2, 4, and 6 months postintervention will be completed either in-person or via phone. We will provide modest honoraria to compensate participants for their time for completion of each study assessment: US$10 for baseline (BL) survey; US$18 for exit survey; US$20 for the 2-month follow-up survey; and US$25 for the 4- and 6-month follow-up survey, consistent with other local research and based on input from our local partners and Mexican investigators on appropriate compensation. Compensation will not be provided for attendance at intervention sessions, as this was advised by local community partners and investigators as critical for long-term feasibility and sustainability of intervention uptake locally.
Enlarge this image.Figure 1. Theory-based 'Mama Empoderada' intervention components, proposed mechanisms and outcomes. 1 Components and mechanisms informed by the protective factors framework; 2 Components and mechanisms informed by trauma theory.
Study measures
| Primary outcomes | |
| Anxiety symptoms | General Anxiety Disorder Scale (7-item) (GAD-7)27 |
| Depression symptoms | Patient Health Questionnaire (PHQ-9)32 |
| Parenting stress | Parental Stress Scale33 |
| Intermediate/secondary outcomes | |
| Resilience and coping | Brief Resilience Scale,34 DSM-5 Level 1 Cross-Cutting Measure32 |
| Parenting skills | Parenting Sense of Competence Scale35 |
| Service utilisation | Use of HIV/STI services, use of other health services, barriers to services |
| Social support | Multidimensional Scale of Perceived Social Support,36 DSM-5 Level 1 Cross-Cutting Measure32 |
| Substance use | Global Adult Tobacco Survey,37 Alcohol Use Disorders Identification Test (3-item),38 DSM-5 Level 1 Cross-Cutting Measure,32 use of other substances |
| Health and healthcare access | Self-rated health,39 experiences of care-seeking and treatment, recent healthcare needs and treatment |
| Disability | WHODAS 2.040 (cognition, mobility, self-care, social interactions, life activities, community participation) |
| Mental health | DSM-5 Level 1 Cross-Cutting Measure,32 Post-Traumatic Stress Checklist41 |
| Individual and demographic factors | |
| Demographics | Age, race, sex at birth, gender, sexual orientation, marital and partner status, household size, education level |
| Reproductive history | Methods of contraception; HIV/STI risk behaviours; pregnancies and live births; access to prenatal and perinatal care; pregnancy intention; Pregnant Persons Experience of Mistreatment by Providers Index42; Reproductive Autonomy Scale43 |
| Gendered social and structural vulnerabilities | |
| Violence | Sexual Relationship Power Scale44; frequency, types, and perpetrators of violence, WHO Intimate Partner Violence Scale,45 Exposure to Community Violence |
| Economic factors | Household income, employment status |
| Housing and household | Living situation in Tijuana, housing insecurity, presence of children |
| Migration experiences | Country of origin, duration in Tijuana, duration of transit, migration trajectory, immigration status, detention/deportation |
| Racism and discrimination | Everyday Discrimination Scale,46 Border Community & Immigration Stress Scale46 |
| Food insecurity | Reduced Coping Strategies Index47 |
| Process indicators | |
| Acceptability of intervention | Perceived intervention effectiveness, coherence and acceptability28 |
Counseling and referrals
Given the sensitive nature of the topics addressed in this study, all study staff have received training in trauma-informed approaches and in the recognition and first response (psychological first aid) for emotional distress. We have prepared detailed resource lists containing pre-vetted mental health providers available in the city or remotely, which will be used to offer and facilitate participant referrals. Participants exhibiting distress during implementation will be immediately connected to a study coordinator (a trained counsellor) and connected to known local mental health providers.
Participant retention and follow-up
To support follow-up and retention over the 5-week intervention and at 2-, 4- and 6-month follow-up periods, we will use the following cohort retention strategies: (1) maintaining and updating contact information (eg, cell phone, WhatsApp, address, services visited, trusted contacts) at each visit; (2) providing increasing incentives at follow-up survey visits; (3) follow-up surveys will be offered by phone or in person to increase accessibility and account for potential out-migration; (4) visit reminders provided via phone/text reminders, community outreach and ongoing communication with participants; (5) community-based project staff with extensive experience in developing rapport and maintaining connections with local migrant women will lead recruitment, follow-up and facilitate sessions, as they are deeply familiar with the needs and realities of our target population; and (6) working closely with local partner NGOs that maintain regular contact with the study population.
Training and fidelity monitoring
All data collection and intervention sessions are led by a team of local coordinators and facilitators/interviewers, which includes clinically trained staff (licensed psychologists or social workers) alongside community-based staff members with substantial expertise working with migrant women and families locally. All coordinators and facilitators/interviewers have participated in intensive training (20+ hours) on the delivery of the manualised intervention and control content, which includes didactic presentations, role modelling of intervention components, and role-playing exercises, as well as ongoing reflective consultation. Staff also receive extensive training in research ethics, trauma-informed practices, questionnaire administration, and participant referrals and support. All staff will receive ongoing training and check-ins on a weekly basis to troubleshoot issues and support consistent intervention and control content delivery. Intervention sessions will be monitored for fidelity via use of a standardised scoresheet evaluating each session for content adherence and consistency; re-training will occur, where needed, to strengthen fidelity.
Power
Consistent with the goals of a pilot study, this study is not powered to detect significant differences in outcomes by study arm, but rather designed to obtain estimates of effect sizes for a subsequent efficacy trial. The planned sample size (n=100) is consistent with methodological literature suggesting this to be sufficient for a pilot study.29 Based on effect sizes from the original ‘Mom Power’ intervention, we expect to have >85% power to detect a significant change in prevalence of depressive symptoms.
Statistical analyses
Statistical analyses will compare primary (symptoms of depression and anxiety; parenting stress) and intermediate outcomes (eg, resilience, service utilisation) of participants by exposure to intervention condition. Bivariate and multivariable models will consider potential confounders that differ between comparison groups and are a priori known/suspected to be related to outcomes based on our conceptual framework (figure 1) and prior literature. Models will also consider product terms (one at a time) between exposures of interest and these covariates. Although this is a pilot study, our analytic plan will follow Consolidated Standards of Reporting Trials guidelines for RCTs.30 We will assess descriptive statistics on intervention acceptability using data from the intervention condition participants’ exit surveys. To assess whether the intervention predicts changes in primary outcomes, we will conduct intent-to-treat analyses of differences in primary (symptoms of depression and anxiety; parental stress) and secondary outcomes between intervention and control groups at exit, 2, 4 and 6 months, using either or generalised estimating equations for categorical outcomes and linear mixed models to model continuous outcomes. We will use bivariate and multivariable regression to explore which theory-based mechanisms of action predict changes in depression and anxiety symptoms and parenting stress and explore factors associated with differential intervention response (eg, longer migration duration, trauma). Although the study is not powered to formally detect mediating or moderating effects, descriptive analyses of possible differential intervention response based on comparisons by demographics, migration stressors (eg, duration, legal status) and trauma will provide an important basis for effect sizes and hypotheses for a subsequent efficacy trial.
Patient and public involvement
Meaningful community engagement is critical for addressing power imbalances inherent in research with marginalised communities, as well as to ensure the relevance and appropriateness of the research. All aspects of this study will involve community engagement31 and support capacity-building with our local NGO partners. Intervention adaptation, recruitment, interpretation and translation of findings are being conducted in close collaboration with AOL, a large binational NGO providing legal and humanitarian support to migrants in the US and Tijuana annually, as well as the study’s CAB, which is comprised of stakeholders, community leaders and service providers from nine local NGOs.
We have worked closely with our community partners, CAB, and local migrant mothers and health and community stakeholders to develop and adapt the ‘Mamá Empoderada’ intervention and study design. From Fall 2023 to Spring 2024, we gathered local community feedback on the intervention content, delivery and evaluation design from a series of focus groups with migrant mothers and NGO stakeholders and established our CAB. The insights generated from these activities were used to carefully adapt and refine the intervention content, delivery and questionnaire measures. Working closely with AOL and the CAB, we will continue to meet with the CAB quarterly throughout the duration of the trial to review progress, seek guidance and support for addressing potential barriers and facilitators to recruitment and retention, troubleshoot unanticipated challenges, interpret interim and final results, and collaborate on dissemination efforts. Finally, the entire intervention protocol was pretested with a diverse sample of migrant mothers with young children (n=14) prior to launching the pilot trial, which informed final adaptations (eg, addressing barriers to participation and retention, increasing cultural appropriateness and participant appeal, refining survey measures) prior to initiation.
Ethics and dissemination
This study has been registered at ClinicalTrials.Gov (ID: NCT06468046) and has been approved by the San Diego State University (SDSU) (Protocol #: HS-2023–0135) and El Colegio de la Frontera Norte (COLEF) (Protocol #: 105_261023) Research Ethics Boards and complies with ethical guidelines set out by the Declaration of Helsinki. All participants will provide informed consent prior to enrolment. Potential participants will be informed about the nature of the study and its possible risks and benefits during the informed consent process, which will include a detailed explanation of aims, procedures, risks, benefits and the voluntary nature of the study based on principles of co-learning. The consent form is available in Spanish and will be reviewed with the participant in a private location with a member of the study team prior to enrolment. The participant will be informed that they can refuse to answer any question and may leave the study at any time.
For the purposes of this study, participant data will be de-identified and securely stored in REDCap. To monitor recruitment and retention, the data manager will generate reports of each from REDCap and will export REDCap datasets on a weekly basis to monitor data quality. All surveys will be programmed and administered electronically in REDCap. Overall data safety and monitoring and oversight responsibilities for the study are held by the principal investigators (PIs) and the institutional review board. Scientific oversight will be led by the PIs and the research team in collaboration with a Scientific Monitoring Committee (SMC). SMC members are interdisciplinary researchers experienced with behavioural interventions with marginalised populations including migrants and other marginalised populations at the Mexico-US border who are deeply familiar with the local study context and population. All SMC members are external to the study and are independent from the funding agency. The SMC will meet a minimum of annually to provide scientific oversight and guidance, including reviewing and providing guidance on the protocol, progress, interim results, unanticipated challenges and other factors that could arise or affect scientific progress. Monitoring of potential adverse events will be a standing item on the research team’s weekly meeting. All adverse events will be documented, as will any resulting responses implemented by the study team.
In accordance with requirements from the National Institute of Mental Health (NIMH), we will share protocols, instruments, data dictionaries and data with the NIMH Data Archive repository. De-identified data will be uploaded via creation of a unique pseudo-Global Unique Identifier to securely share data for consenting participants. Quantitative data from this pilot trial will be preserved to enable sharing of data, with the exception of migration experiences given the highly criminalised and marginalised nature of the population and the risks of disclosing such data.
In collaboration with our community partners, results will be disseminated via peer-reviewed publications, presentations and plain-language reports to community, clinical and policy audiences. If efficacious, this intervention is highly promising as a novel, low-cost and feasible model that could be implemented in border settings in Mexico, the USA and elsewhere. Amid rising population displacement and prolonged and traumatic migration journeys, this study addresses an urgent need for scalable and tailored mental health prevention for migrant women and families in border contexts.
Ethics statements
Patient consent for publication
Not applicable.
Contributors SMG drafted and critically revised the protocol. The study was co-designed by SMG and IB-C. KRa contributed to co-drafting sections of the protocol. All authors (CH, CM-T, EP, GR, MA, KRa, KRo, IB-C, SMG) critically reviewed, edited and approved the protocol prior to publication. Dr. Goldenberg serves as guarantor of the data.
Funding This work was supported by the National Institute of Mental Health [1R34MH134047]. Seed funding was also supported by San Diego State University and the San Diego Center for AIDS Research (P30 AI036214).
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer-reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
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; Ramage, Kaylee 2 ; Martinez-Torteya, Cecilia 3 ; Pitpitan, Eileen 4 ; Rosenblum, Katherine 3 ; Hernandez, Chelsie 1 ; Alvarez, Monica 5 ; Rangel, Gudelia 6 ; Bojorquez-Chapela, Ietza 7 1 School of Public Health, San Diego State University, San Diego, California, USA
2 School of Public Health, University of Tennesse, Knoxville, Tennessee, USA
3 Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA
4 School of Social Work, San Diego State University, San Diego, California, USA
5 Comisión de Salud Fronteriza México-Estados Unidos, Tijuana, Mexico
6 Comisión de Salud Fronteriza México-Estados Unidos, Tijuana, Mexico; El Colegio de la Frontera Norte, Tijuana, Mexico
7 El Colegio de la Frontera Norte, Tijuana, Mexico