JMIR Research Protocols

School-Based Universal Mental Health Prevention Programs for Children Aged 6 to 9 Years in Low- and Middle-Income Countries: Protocol for a Scoping Review

2026-04-10T15:00:20-04:00

Background: While the onset of most mental health conditions occurs in later childhood or adolescence, the early years present an important window for prevention. Worldwide, universal school-based prevention interventions have been shown to be effective in promoting child mental health. Nevertheless, little is known about universal school-based prevention programs targeting children aged 6 to 9 years in low- and middle-income countries (LMICs). Objective: This scoping review aims to identify promising, potentially feasible, and possibly evidence-based school-based universal prevention mental health programs for children aged 6 to 9 years in LMICs. Methods: This scoping review is planned according to the Joanna Briggs Institute framework developed by Arksey and O’Malley, with enhancements proposed by Levac et al. Eligible studies will focus on universal prevention school-based mental health interventions with feasibility and/or mental health outcomes that include children aged 6 to 9 years. Additional inclusion criteria are peer-reviewed published and unpublished studies, including gray literature such as theses and dissertations, preprints, conference proceedings and papers, and government reports and publications. There are no limits to the date of publication, but only studies published in English and conducted in LMICs will be included. The search strategy was iteratively developed and finalized, following which major databases, namely, PubMed (MEDLINE), Scopus (Embase), EBSCOhost (PsycInfo, CINAHL, PsycArticles, ERIC, Teacher Reference Center, Academic Search Premier, and SocINDEX), CENTRAL, ProQuest, the Open Science Framework, and the International Clinical Trials Registry Platform, were searched. Titles and abstracts are being screened in addition to manual searches of the reference lists of previous reviews. Experts will be consulted for further study suggestions, and reference mining will be conducted with the included studies. A descriptive and numerical summary will reflect basic program characteristics. A preliminary data extraction chart curated around the research questions will be used for deductive and inductive data analysis. The entire scoping review will be reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Results: In November 2025, the search strategy was finalized. All database searches were completed by early December 2025, yielding 7511 records. After removing duplicates (n=3022), 4489 records underwent title and abstract screening. Of these, 25 records met the criteria for full-text review, which is currently ongoing. Data extraction and analysis should take place between April and May 2026. The scoping review findings will be submitted to a relevant peer-reviewed journal by July 2026 and presented at conferences. Conclusions: This review will provide a description of feasible and potentially effective school-based universal mental health programs specific to children aged 6 to 9 years living in LMICs. The findings may assist with efficient insight into available programs for implementation or adaptation among the stipulated population in the future. Trial Registration: Open Science Framework W42CE; https://osf.io/w42ce/overview International Registered Report Identifier (IRRID): PRR1-10.2196/87105

Assessing Neonatal Transport, Health Outcomes, and Psychosocial Inequities Among Black, Very Preterm Infants and Their Families to Advance Health Equity: Protocol for a Mixed Methods Study

2026-04-10T14:30:09-04:00

Background: Despite medical advancements, preterm birth rates in the United States remain high and contribute substantially to infant mortality and long-term morbidity, with Black families disproportionately affected. Very preterm (VPT) infants—born between 24 and 30 weeks’ gestation—are frequently delivered at community hospitals that lack advanced neonatal care and therefore require postnatal transport to tertiary neonatal intensive care units (NICUs). While neonatal transport is essential for optimizing infant outcomes, it can create additional challenges for families, including geographic separation from the NICU, disruptions to early parent-infant bonding, and increased parental psychosocial stress. These challenges may be further intensified by social vulnerability and experiences of perceived discrimination in health care settings. Objective: This study examines associations between neonatal transport, infant health outcomes, and the psychosocial well-being of Black parents with VPT infants. It also examines how structural inequities and social vulnerability shape experiences from delivery through NICU hospitalization. Methods: This protocol describes a longitudinal mixed methods multiple case study at a single perinatal center in South Carolina. Up to 10 cases of VPT Black infants transported from community hospitals between May 2023 and January 2024 are included. Each case includes the infant and mother, with partners invited. Quantitative data include infant outcomes from electronic medical records, neighborhood disadvantage using the Area Deprivation Index, and parent surveys of stress, anxiety, depression, bonding, perceived discrimination, and access to care. Qualitative data come from semistructured interviews guided by an adaptation of the National Institute on Minority Health and Health Disparities Research Framework and analyzed using reflexive thematic analysis. Data are integrated within each case to create structured summaries, followed by cross-case comparisons to identify patterns and variation. Results: The study was funded by the National Institute of Nursing Research in July 2023. Participant enrollment occurred between May 2023 and January 2024, with 6 cases enrolled. Data collection and electronic medical record abstraction were completed in May 2024, with analysis completed by July 2024. This manuscript reports the protocol and analytic plan. Detailed results will be reported in 2 companion manuscripts currently under review; publication of one is anticipated in fall 2026. Conclusions: This protocol outlines a novel mixed methods case study of neonatal transport and infant and parent outcomes among Black families. The study is exploratory and intended to generate hypotheses and inform future larger scale research and intervention development to support parental mental health, reduce disparities, and improve care experiences following preterm birth and neonatal transport. International Registered Report Identifier (IRRID): RR1-10.2196/84626

Evaluating the Combined Effects of an Adverse Childhood Experiences–Focused Family Advocate Model and the Strengthening Families Program: Study Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial in 36 New Jersey Communities

2026-04-09T15:45:10-04:00

Background: Early exposure to adverse childhood experiences (ACEs), such as parental substance use, elevates the risk of future substance use and drug overdose, and in the absence of intervention, could perpetuate a cycle of substance-related ACEs across generations. Although research suggests that effectively decreasing the prevalence and impact of ACEs and substance use can benefit from addressing both family- and community-level factors in tandem, there is a critical gap in the evidence base pertaining to interventions that effectively integrate these 2 factors to prevent substance use and ACEs. Objective: This study aims to conduct a rigorous evaluation of a novel intervention that integrates the established, evidence-based Strengthening Families Program with clinically trained, trauma-informed family advocates who will assist families in accessing resources related to ACEs and social determinants of health. Methods: This study uses a hybrid type 1 effectiveness-implementation trial design, which is used to test a clinical intervention while gathering information on its delivery during the effectiveness trial and on the potential for implementation in real-world settings. Our hybrid type 1 design consists of 3 components. A cluster-randomized controlled trial will be used to test the effectiveness of the intervention on substance use, overdose, and ACEs in 36 New Jersey communities. A robust process evaluation informed by the Consolidated Framework for Implementation Research will be used to explore implementation barriers and facilitators. A cost evaluation will be conducted to accurately estimate the costs required to implement the intervention components and assess the cost-effectiveness of the intervention. Results: Funding was awarded in 2022, and institutional review board approval was obtained in November 2023. Intervention and evaluation development lasted approximately 1 year, with study partners engaged in the co-design process to ensure alignment with the principles of community-placed behavioral health research. Study recruitment began in November 2023 and is anticipated to continue until September 2026. Final data collection is anticipated by March 2027, followed by data analysis. Conclusions: This study evaluates a novel intervention that integrates New Jersey’s established, evidence-based Strengthening Families Program with clinically trained, trauma-informed family advocates who will assist families in accessing community resources. By evaluating both family- and community-level outcomes through a hybrid type 1 design, the study bridges a key gap in the evidence base and provides a framework for combining multilevel interventions to reduce the long-term impacts of ACEs and substance use on youth and families. Future findings will provide critical insight related to intervention effectiveness, implementation barriers and facilitators, and the intervention’s associated costs and cost-effectiveness. Trial Registration: ClinicalTrials.gov NCT06236100; https://clinicaltrials.gov/study/NCT06236100 International Registered Report Identifier (IRRID): DERR1-10.2196/85151

Correction: Evaluation of the Comparative Efficacy of an Ayurvedic Formulation (Nimba-Amalakyadi Powder) vs Metformin in the Management of Type 2 Diabetes Mellitus: Protocol for a Pilot Study

2026-04-09T14:45:10-04:00

Effectiveness of Ayurvedic Nutritional Supplements and Yoga Protocol in Reducing the Incidence and Severity of Acute Mountain Sickness (AYAMS Study): Study Protocol for an Open-Label Randomized Controlled Trial

2026-04-08T16:30:11-04:00

Background: Acute mountain sickness (AMS) poses a unique and formidable challenge to healthy personnel at high altitudes. Objective: This randomized controlled trial (RCT) protocol aimed to assess the effectiveness of Ayurvedic nutritional supplements in conjunction with a yoga protocol in reducing the incidence and severity of AMS among healthy personnel stationed in the challenging high-altitude landscapes of the western Himalayas. Methods: The proposed open-label, parallel-group RCT was conducted in apparently healthy individuals of any gender aged 18‐50 years. The study was conducted at two distinct high-altitude stages within the western Himalayan region: stage I, situated at an elevation ranging from 9000 to 12,000 feet and stage II, spanning 12,000 to 15,000 feet. A total of 1660 participants (n=830 per stage) underwent random assignment in a 1:1 ratio to receive either the existing acclimatization schedule (AS) for high altitude (control group) or the Ayush intervention (Ayush group) in addition to the AS. The participants in the Ayush group received Ayurvedic nutritional supplements, including the Ayur-nutri kit (Ayush poshak yoga, 25 g, and Ayush cardiac care tea, 125 mL), twice daily, along with a yoga protocol (60 min daily) for 120 days. The primary outcome was the incidence of AMS, assessed using the 2018 Lake Louise Scoring System, and the proportion of participants with a Lake Louise Scoring System score of 6 or higher during the first 7 days from baseline. The secondary outcome measures included the proportion of participants with thromboembolic events; changes in coagulation and hemostasis activation markers and proinflammatory markers; and changes in self-reported negative emotional states (depression, anxiety, and stress), sleep quality, and overall quality of life (assessed through Depression Anxiety Stress Scale-21 items, Pittsburgh Sleep Quality Index, and 12-item short-form, respectively) on day 60 and day 120 from baseline. Results: The study was funded in March 2023. The data collection was completed in December 2023. A total of 1660 participants were enrolled in the study. The analysis of the study data is in progress. The study outcomes are expected to be published by December 2026. Conclusions: This RCT was the first of its kind to explore the potential benefits of using Ayurvedic nutritional supplements and a yoga protocol in conjunction with the standard AS to reduce the occurrence and severity of AMS among healthy personnel. The outcomes of this trial can aid in better acclimatization and resilience among healthy personnel at high altitudes. Trial Registration: Clinical Trial Registry of India CTRI/2023/03/051028; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODI3Njg=&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/81567

Taunakitanga Takitini, Reframing Self-Management Support for All in Aotearoa New Zealand: Protocol for a Participatory Case Study Program of Research

2026-04-08T14:15:03-04:00

Background: Increasingly, people are living with multimorbidity and long-term conditions or permanent impairments, which contribute substantially to health loss and additional health inequity. Critical to managing this health crisis is the appropriate support provided by health and social services. International research has informed the implementation of supported self-management knowledge into Aotearoa New Zealand. Meagre attention has been given to how New Zealand health care organizations can appropriately support people to self-manage their lifelong conditions within their own life contexts and cultures. Currently in New Zealand, those experiencing the greatest health inequities are Māori and Pacific peoples—Tāngata Whaikaha Māori (Māori living with disability) and people with learning (intellectual) disability who live with long-term health conditions or permanent impairments. This research aims to challenge and reframe supported self-management in New Zealand to enable our underserved populations and their whānau (families) to receive appropriate support to live well. Objective: We aim to reconceptualize supported self-management in New Zealand as a holistic approach to the provision of support and care within the complexities of the lived human and whānau experience. In total, three objectives will be considered across 3 key populations of people with long-term conditions or permanent impairments (Māori, Pacific Peoples, and those with learning disability) to (1) understand our community partners’ and their communities’ aspirations for living well and how best to support these desires, (2) develop innovative models of support by working alongside communities to enable supported self-management within their own context, and (3) implement models and evaluate outcomes. Methods: Embracing social construction of reality, this participatory case study program uses mixed methods and implementation evaluation design and is underpinned by Whānau Tuatahi (Māori) and Fonua (Tongan) research models and the Transformative Paradigm. Moreover, 3 case studies, 1 for each population group, will apply the same program objectives. Objectives 1 and 2 will be addressed with qualitative methodologies underpinned by relevant participatory designs. Objective 3 will use appropriate implementation frameworks. Results: Funded in October 2023, we have completed 2 years of this 5-year program grant. These first 2 years were focused on relationship building, ethical applications, research capability, and capacity building. Substantial, progressive consultation with the respective communities of each case study was undertaken. Conclusions: New knowledge generated across our program has the potential to inform New Zealand policy and practice about service delivery acceptable to the people to whom it matters (particularly Māori, Pacific Peoples, and people with a learning disability) and places emphasis on well-being promotion. This approach focuses on the inherent strengths and abilities of people, rather than the deficits or problems, acknowledging the wealth of expertise and experience people living with long-term conditions or permanent impairments bring, and builds relationships and partnerships between people and health care partners.

Exploring the Role of Dairy Consumption on the Growth and Development of Canadian Children: Protocol for a Longitudinal Mixed Method Research

2026-04-08T14:00:22-04:00

Background: Childhood is a critical period for physical and cognitive development, in which nutrition plays a fundamental role. Dairy products, rich in calcium, vitamin D, and high-quality protein, are essential for bone health, body composition development, and cognitive performance. However, evidence on the long-term impact of dairy consumption on children’s growth and development, particularly in the Canadian context, is limited. Additionally, recent revisions to the Canadian Food Guide, which classify dairy as part of the protein group rather than as a separate food group, may influence caregiver perceptions and children’s dairy intake. Objective: This protocol describes a study designed to examine the longitudinal relationship between dairy consumption and key indicators of growth, bone health, and cognitive development in Canadian children aged 5 to 11 years. The secondary objective is to assess caregivers’ and children’s knowledge, attitudes, practices, and perceived facilitators and barriers to dairy consumption. Methods: A longitudinal convergent parallel mixed methods study is being conducted with 4 data collection points over 2.5 years (baseline, and approximately 10, 20, and 30 months). Eligible participants include children aged 5 to 11 years at baseline, residing in the Saskatoon area, with no diagnosed conditions or medication use affecting bone metabolism or cognitive development. Quantitative data include dietary intake, anthropometrics, body composition, bone density and microarchitecture, subjective and objective measures of physical activity, cognitive assessments, and a salivary biomarker. The qualitative component aims to investigate facilitators and barriers to dairy consumption through interviews with caregivers. Mixed-effects models will be applied to assess longitudinal associations, and thematic analysis will be used to analyze qualitative data. Quantitative and qualitative findings will be integrated at the interpretation stage to inform overall conclusions. Results: Ethics approval was obtained from the University of Saskatchewan Research Ethics Board (Bio-3339) in 2022. Recruitment began in September 2022 and concluded in February 2025. A convenience sample of 166 volunteer children from Saskatoon was recruited, with efforts made to achieve demographic diversity. Data collection is ongoing and expected to finish by August 2027. Data analysis is underway, with preliminary findings expected to be published in 2026. Conclusions: This protocol outlines a comprehensive study that aims to generate context-specific evidence on the role of dairy in child development, with implications for developing responsive dietary guidance and public health policy in Canada. International Registered Report Identifier (IRRID): DERR1-10.2196/87415

Undergraduate Interprofessional Education: Protocol for a Mixed Methods Study

2026-04-08T14:00:22-04:00

Background: Interprofessional education (IPE) is essential for fostering collaboration and communication among health care professionals to improve patient outcomes. Early IPE training for prehealth undergraduate students has been shown to enhance teamwork, dismantle stereotypes, and build self-efficacy in health care settings. Self-efficacy is the belief that one can achieve their goals and succeed at tasks. These outcomes contribute to creating a cohesive and equitable health care environment focused on patient-centered care. Despite evidence supporting the benefits of IPE training, there is a lack of consistent implementation at the undergraduate level across institutions. Objective: Programs that have adopted IPE have demonstrated improved student preparedness, better interprofessional collaboration, and enhanced patient care outcomes. Our study addresses this gap in undergraduate IPE among institutions by examining the impact of a structured IPE training program, Pathway to Health Professions, designed for prehealth East Carolina University undergraduate students who are members of Buff in Scrubs, an East Carolina University organization. Methods: Our study uses a mixed methods approach, including retrospective surveys and open-ended questions, to assess changes in participants’ attitudes, skills, and competencies before and after training. Data will be collected from January 2025 to April 2025. Results: We hypothesize that early and structured exposure to IPE training will significantly enhance prehealth undergraduate students’ confidence, understanding of interprofessional roles, and ability to collaborate effectively. By focusing on self-efficacy–based skills, we hope to equip prehealth students with the confidence to apply to their desired health professions program. Conclusions: This paper outlines the protocol for Pathway to Health Professions, a prehealth preparation IPE program. Future testing of the use of this program is outlined. We hypothesize that the results from the future testing of this program will show an improvement in undergraduate prehealth students’ self-efficacy related to graduate school readiness. International Registered Report Identifier (IRRID): DERR1-10.2196/74394

Combating Dermatologic Misinformation on Social Media via a Training Program for Health Care Professionals: Protocol for a 2-Phase Pilot Mixed Methods Study

2026-04-08T13:45:10-04:00

Background: The rise of social media has drastically altered the landscape of health information dissemination. While these platforms can promote health literacy, they are also rife with skin care misinformation, often spread by nonexperts. This has led to harmful consequences, including improper product use and delayed treatment. Despite their potential to mitigate misinformation, dermatologists and health care professionals remain underrepresented on platforms such as TikTok and Instagram. Objective: This protocol describes a pilot study designed to evaluate the feasibility, acceptability, and preliminary efficacy of a social media training program aimed at equipping dermatology-focused health care professionals and students with skills to create accurate, engaging educational content. Methods: This sequential mixed methods study will be conducted at the University of Pittsburgh. Phase 1 consists of a 5-module online training program completed by 50 health care professionals and students in dermatology or dermatology-adjacent fields. Pretraining and posttraining surveys will be conducted to assess changes in participants’ knowledge, confidence, intent to engage in public-facing dermatology education, and satisfaction with the training (posttraining survey only). Phase 2 will involve the selection of 12 participants from phase 1 to apply the training by creating and posting short-form dermatologic educational videos on a study-managed social media channel. Exploratory outcomes include social media engagement metrics, qualitative content analysis of public comments, and individual qualitative interviews with participants to assess audience response and potential knowledge impact. Results: Recruitment for phase 1 of the study is currently underway. As of January 2026, a total of 46 out of the target 50 participants have been successfully enrolled. Data collection for phase 1 is expected to be completed by the end of April 2026. Data analysis will begin shortly thereafter, with final analyses anticipated to be completed by September 2026. Recruitment for phase 2 is expected to begin in April 2026, with the goal of concluding data collection and analysis by the end of 2028. Conclusions: This pilot study will inform the feasibility and refinement of social media training interventions designed to empower health care professionals to engage in evidence-based dermatologic health communication online. International Registered Report Identifier (IRRID): DERR1-10.2196/81003

Cultural Adaptation of a Digital Mobile App for Bipolar Disorder (PolarUs): Protocol for a Qualitative Co-Design Study

2026-04-08T13:45:10-04:00

Background: Bipolar disorder (BD) affects approximately 40 million people worldwide and is a chronic, potentially disabling mood disorder. Although effective treatments exist, access to evidence-informed psychosocial care remains limited, particularly for culturally and linguistically diverse populations, contributing to persistent global treatment gaps. Digital mental health interventions (DMHIs), such as smartphone apps, offer a promising means to improve access to self-management support and quality of life (QoL), an outcome prioritized by people with BD and in clinical guidelines. However, most apps for BD lack quality and are not culturally adapted or co-designed with people with BD, limiting relevance and engagement. PolarUs (mobile app) is an evidence-informed DMHI developed using co-design with people with BD. The app is structured on the core 14 domains from the Quality of Life in BD scale, the only BD-tailored scale, combined with psychoeducation on self-management strategies and QoL. A recent pilot study demonstrated promising QoL, clinical, and feasibility outcomes. Objective: This study aims to culturally and linguistically adapt the PolarUs app into French, Chinese, and Spanish for the North American context using qualitative and co-design methods. Methods: Guided by community-based participatory research principles, whereby end users are engaged throughout the research process, and the Ecological Validity Framework of Bernal et al, we will engage advisory groups of people with lived experience from each linguistic community throughout the cultural adaptation process. Semimonthly virtual meetings will support systematic cultural adaptation of the self-management strategies, affirmations, and resources while maintaining fidelity to core evidence-based components. This will include cultural tailoring of app content and the identification of culturally appropriate resources. Advisory groups will also contribute to the cointerpretation of findings and the co-design of culturally appropriate recruitment and implementation strategies of PolarUs for a future clinical trial. Meetings will be recorded and coanalyzed as research data with advisory groups using qualitative reflexive thematic analysis to capture advisory group perspectives and experiences. Results: This study was funded in October 2024. As of January 31, 2026, we enrolled 7 participants, and the results are expected to be published in the fall of 2026. Conclusions: The findings will support the development of a culturally appropriate DMHI for BD for additional linguistic communities, advance cultural adaptation methodologies, and inform preparation for a future clinical trial. This study will produce the first culturally adapted, BD-specific DMHI developed through co-design using a community-based participatory research approach with multilingual end users from traditionally underserved communities, advancing equitable access, engagement, and scalability of DMHIs for BD and digital health care more broadly. International Registered Report Identifier (IRRID): PRR1-10.2196/92600