SBIR-STTR Award

Postpartum depression (PPD) constitutes a general health problem occurring in 10-16% of recently delivered mothers. The impact of PPD is profound with considerable emotional pain for the mother as well as disturbances in infant development and later child adjustment. Although the prevention of this disorder has garnered much attention, few preventative interventions have demonstrated efficacy, replicated findings, used validated diagnostic measures for PPD, or used heterogeneous samples of women. The ROSE Program (Reach Out, Stay Strong, Essentials for mothers of newborns), an intervention that has been found in three clinical trials to significantly reduce cases of PDD in at risk pregnant women on public assistance, targets those factors that play a significant role in the development of PPD (i.e., poor social support, role transition, and life stressors) and is administered during weeks 20 - 35 of pregnancy and within 2-weeks postpartum. The aims of the phase 1 of this SBIR proposed project is to develop a high-reach, easily implementable, low-cost, prototype of the ROSE Program and test its acceptability and feasibility among pregnant women at risk for PPD. More specifically, the team will develop a functional prototype of a ROSE Program session, improve the clarity, content, acceptability, and feasibility of the ROSE session using information gathered from a preliminary group of pregnant women and antenatal healthcare providers, and assess the acceptability, feasibility, and usability of the ROSE Program prototype for pregnant women at risk for PPD through pilot testing with our target population. Thus, phase I development will be accomplished by an iterative process of feedback and refinement through collaboration with Debra Fox, President and CEO of Fox Learning Systems, Inc., Dr. Zlotnick at Women and Infants Hospital (WIH), and Dr. Sarah Noble at Paley OB/GYN Clinic of the Albert Einstein Healthcare Network. Fox Learning Systems brings expertise in the development of multimedia health education tools across a range of technology platforms. Dr. Zlotnick at WIH developed the ROSE Program and tested the in-person version of ROSE in randomized control trials with pregnant women on public assistance at risk for PPD, with rural African-American pregnant women, and with pregnant teens. Dr. Noble will provide supervisory and clinical support at the research site in Philadelphia. Phase 1 will lay the foundation for the Phase II development and testing of a Web-based version of ROSE Program that will provide individualized and interactive feedback, retain the core features of the ROSE Program, and represent a low threshold, low-cost service with a high reach. This Web-based intervention to reduce the risk of PPD that is grounded in an empirically supported intervention would improve on products currently available in the marketplace. It will be accessible on kiosks in OB offices, on home devices, and smart phones. Finally, it will be integrated into the prenatal clinic visits of Federally Qualified Health Centers or other inner-city obstetric programs caring for women at high risk for PPD.

Public Health Relevance Statement:
Project Narrative Postpartum depression (PPD) constitutes a significant health problem that affects hundreds of thousands of American mothers annually. Although the prevention of this disorder has garnered much attention, few preventative interventions for PPD exist with demonstrated efficacy. The proposed project will develop a prototype of an empirically supported intervention to reduce PPD (the ROSE Program) and test its acceptability and feasibility among pregnant women at risk for PPD laying the foundation for the complete development and testing of a Web-based version of ROSE Program; a low threshold, low-cost service with a high reach.

Project Terms:
Affect; Attention; youngster; childrens'; children; Children (0-21); Child Youth; 0-11 years old; Child; Clinic Visits; Clinical Trials; cost effectiveness; Disadvantaged; National Government; Federal Government; Feedback; Foundations; Foxes; Goals; Health; Health Tutoring; Health Instruction; Health education; treatment provider; medical personnel; healthcare personnel; health provider; health care worker; health care personnel; Healthcare worker; Healthcare Providers; Health Care Providers; Health Personnel; Health Planning; Hospitals; Infant; Newborn Infant; newborn children; newborn child; Newborns; 0-4 weeks old; Interview; Learning; Mothers; Persons; Discipline of obstetrics; Obstetrics; Online Systems; web based; online computer; On-Line Systems; Pain; Painful; Philadelphia; Play; Pregnancy; Gestation; Third Pregnancy Trimester; Third Trimester; Last Trimester; Pregnancy Trimesters; Pregnant Women; expecting mother; expectant mother; Public Assistance; Research; Risk; Role; social role; Social support; social support network; Surveys; Survey Instrument; Target Populations; Technology; Testing; Time; Woman; Measures; Female Health; Women's Health; health care; Healthcare; post-partum; Postpartum; Postpartum Period; Caring; improved; Site; Clinical; Phase; Infant Development; Postnatal Depression; Post-Partum Depression; Post-Natal Depression; Postpartum Depression; women at high risk; High Risk Woman; Collaborations; randomized controlled study; Randomized Controlled Trials; tool; Diagnostic; Multimedia; Multimedium; Life; programs; Home environment; Home; Clinic; System; inner city; Services; American; stressor; prenatal; unborn; disorder prevention; disease prevention; pregnant teen; teens who are pregnant; pregnant adolescent; Devices; Emotional; Sampling; Intervention; interventional strategy; Intervention Strategies; Cellular Phone; smartphone; smart phone; iPhone; Cellular Telephone; Cell Phone; Provider; prevent; preventing; Address; Preventive Intervention; preventional intervention strategy; Prevention intervention; Preventative intervention; Small Business Innovation Research; SBIR; Small Business Innovation Research Grant; Process; developmental; Development; informant; Federally Qualified Health Center; cost; willingness; usability; prototype; clinical care; individualized feedback; interactive feedback; rural African American; antenatal; antepartum

Postpartum depression (PPD) affects 1 in 7 mothers in the US with double the rate among low-income women, causing emotional distress, consequences for infant development and later child adjustment, disruptions in family relationships, and significant financial burden. The ROSE Program (Reach Out, Stay Strong, Essentials for mothers of newborns) is an evidence-based preventive intervention administered as a series of 4 in-person group sessions plus one postpartum booster session. ROSE reduced cases of PPD by half in four clinical trials with low- income women. However, there are major obstacles to disseminating ROSE broadly to women at risk for PPD. If women across the nation could easily access ROSE virtually at the time and place of their choosing, the incidence of PPD could be reduced significantly. Our Phase I project developed a prototype of the first virtual ROSE session and we found 100% of 38 pregnant women at risk for PPD who trialed the session rated their experiences as highly favorable, informative, and helpful. Our current Phase II proposal goal is to finish development of a full app-based ROSE program (e-ROSE) and evaluate the app's outcomes to lay the groundwork for commercialization and broad implementation. We know from previous trials that ROSE has better outcomes than a control consisting of an educational brochure about PPD. We now hypothesize e-ROSE and ROSE delivered as usual (ROSE) will result in better depression outcomes compared to these historical control data. We also hypothesize e-ROSE will result in a better return on investment (ROI) compared to ROSE and compared to utilization data from a second control group of women who were not offered ROSE identified through electronic health records. We will explore if depression outcomes for e-ROSE are non-inferior than for ROSE. Last, we hypothesize that perceived access and satisfaction with the intervention will serve as mediators of depression outcomes. Thus we will complete conversion of all five group sessions to an app-based platform and incorporate additional engagement and support strategies (Aim 1), test its impact on reducing PPD and improving ROI within 3 months post-delivery in a randomized trial (Aim 2), and determine if improving perceived access and satisfaction is a pathway for improving depression (Aim 3). At the end of the project, the e-ROSE product will be ready for Phase III commercialization nationwide allowing easy, low-cost distribution on a variety of platforms to the end-users as well as position us for further research via implementation studies.

Public Health Relevance Statement:
Postpartum depression can be prevented by the Reach Out, Stay Strong, Essentials for mothers of newborns (ROSE) evidence-based program yet continues to affect nearly 600,000 women and their families annually. Our goal is to help reduce rates of PPD by finishing development of a full app-based ROSE program (e-ROSE), evaluate the app's outcomes for depression and return on investment, and determine if satisfaction and perceived access mediate outcomes. At the end of the project, the e-ROSE product will be ready for commercialization nationwide, allowing for easy, low-cost distribution on a variety of platforms to end-users, and we will have laid the groundwork for further research on implementation.

Project Terms:
Affect; Child; 0-11 years old; Child Youth; Children (0-21); youngster; Clinical Trials; Computers; Control Groups; Mental Depression; depression; Diagnosis; Family; Family Relationship; Family Relations; Feedback; Goals; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Incidence; Industry; Newborn Infant; 0-4 weeks old; Newborns; newborn child; newborn children; Health Insurance; health insurance plan; Investments; Medicaid; Mothers; Persons; Booklets; Brochures; Pamphlets; 3rd trimester; Last Trimester; Third Trimester; Third Pregnancy Trimester; expectant mother; expecting mother; pregnant mothers; Pregnant Women; Production; Research; Risk; Testing; Time; Woman; Measures; Mediating; Postpartum Period; Postpartum; post-partum; Schedule; Advisory Committees; Task Forces; advisory team; base; improved; Phase; Series; Infant Development; Randomized Clinical Trials; Training; Post-Natal Depression; Post-Partum Depression; Postnatal Depression; Postpartum Depression; Individual; Health Care Utilization; health care service use; healthcare service use; healthcare service utilization; healthcare utilization; health care service utilization; satisfaction; women at high risk; High Risk Woman; Female Groups; Women's Group; uptake; randomized control trial; Randomized Controlled Trials; Nature; programs; experience; feeling distress; feeling upset; emotional distress; Position; Positioning Attribute; neuropsychiatric; neuropsychiatry; Intervention Strategies; interventional strategy; Intervention; Effectiveness; preventing; prevent; Low income; Mediator; Mediator of Activation; Mediator of activation protein; Data; Preventative intervention; intervention for prevention; prevention intervention; preventional intervention strategy; preventive intervention; Development; developmental; Electronic Health Record; electronic health care record; electronic healthcare record; Pathway interactions; pathway; cost; virtual; design; designing; efficacy evaluation; efficacy analysis; efficacy assessment; efficacy examination; evaluate efficacy; examine efficacy; Outcome; Evidence based program; prototype; commercialization; evidence base; randomized trial; Randomization trial; depression prevention; Preventive service; Preventative service; Financial Hardship; financial burden; financial distress; financial strain; financial stress; implementation cost; implementation investment; implementation study