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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50MH119029-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Palo Alto University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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The investigators propose a pilot randomized controlled trial (RCT) that examines how the redesigned version of Mothers and Babies Online (eMB) can be delivered in the context of home visiting (HV) programs that serve pregnant individuals and new mothers across the United States. The PI, Dr. Darius Tandon (Northwestern University), has conducted extensive research on the in-person Mothers and Babies (MB) intervention with HV programs and has received interest from one of the largest HV models-Parents as Teachers (PAT)-to explore the use of eMB with pregnant individuals that they serve.
This pilot study examining how to incorporate Mothers and Babies Online or "eMB" into home visiting program workflows will have three Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | eMB consists of 8 sessions that correspond with key cognitive-behavioral therapy (CBT) elements: pleasant activities, thoughts, and social support/contact with others. Integrated throughout eMB are activities and skills based on attachment theory that emphasize how each CBT module relates to promoting a strong, nurturing connection between parent and child. eMB includes informational pages, short audio/video clips, images of infants and pregnant women, and worksheets for participants to enter personalized information in response to the lesson content. eMB is individually guided without facilitation, b) clients control the pace by which they review online content, c) and clients can review online content as many times as they like. Participants who receive eMB will also complete assessments at baseline, 1 week post-intervention, and 3 months post-intervention. |
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| Home Visiting Usual Care | No Intervention | Core content of home visiting program services typically address: (a) preparation for childbirth and having a young child in the home, (b) provision of emotional and tangible [e.g., diapers, formula] support, (c) discussion of infant and young child development, (d) linkages to prenatal and pediatric care, and (e) referrals to community resources for social and health services. Those receiving usual care home visiting will not receive any eMB or MB course content. Once study participation is completed, the home visitor may introduce eMB to the participant if they are interested. Participants in the control group will also complete assessments at baseline, 1 week post-intervention (i.e., following 8 weeks of usual home visiting services), and 3 months post-intervention (i.e.g, following 8 weeks of usual home visiting services). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mothers and Babies Online (eMB) | Behavioral | This study's intervention is called Mothers and Babies Online or "eMB", which consists of 8 sessions that correspond with key cognitive-behavioral therapy (CBT) elements: pleasant activities, thoughts, and social support/contact with others. Integrated throughout eMB are activities and skills based on attachment theory that emphasize how each CBT module relates to promoting a strong, nurturing connection between parent and child. eMB includes informational pages, short audio/video clips, images of infants and pregnant women, and worksheets for participants to enter personalized information in response to the lesson content. eMB is individually guided without facilitation, b) clients control the pace by which they review online content, c) and clients can review online content as many times as they like. Participants who receive eMB will also complete assessments at baseline, 1 week post-intervention, and 3 months post-intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptoms | Depression will be assessed using the Center for Epidemiological Studies-Depression Scale, which is a 20-item measure that asks participants to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Scores range from 0-60 with higher scores indicating greater depressive symptomatology | T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in perceived stress | Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), which asks respondents to indicate their levels of perceived stress in the last month, with a response of "0" indicating "Never" and a response of "4" indicating "very often." | T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darius Tandon, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metropolitan Family Services | Chicago | Illinois | 60606 | United States | ||
| Easter Seals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11485953 | Background | Evans J, Heron J, Francomb H, Oke S, Golding J. Cohort study of depressed mood during pregnancy and after childbirth. BMJ. 2001 Aug 4;323(7307):257-60. doi: 10.1136/bmj.323.7307.257. | |
| 15760246 | Background | Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Change in anxiety symptoms | Symptoms of anxiety will be measured using the Generalized Anxiety Disorder-7, which is a 7-item measure that aligns with the Diagnostic and Statistical manual of Mental Disorders (DSM-5) criteria for GAD and assesses anxiety symptom frequency and severity. This instrument has scores ranging from 0-21 with higher scores indicating greater anxiety symptoms. | T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention) |
| Change in parenting sense of competence | Parenting sense of competence (PSOC) is a 17-item scale developed to assess parenting self-esteem. The scale includes two rationally derived scales, Skill-Knowledge and Value-Comforting, referred to as Efficacy and Satisfaction. Each item is answered on a 6-point scale ranging from strongly disagree (6) to strongly agree (1). | T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention) |
| Chang in dimensions of couple relationships | Dimensions of couple relationships will be measured using the Revised Dyadic Adjustment Scale , a report questionnaire that assesses seven dimensions of couple relationships within three overarching categories including consensus in decision making, values and affection, satisfaction in the relationship with respect to stability and conflict regulation, and cohesion. Scores range from 0-69 with higher scores indicating stronger relationships. | T1 (prior to starting intervention), T2 (1 week post-intervention), T3 (3 months post-intervention) |
| Joliet |
| Illinois |
| 60435 |
| United States |
| South Central Iowa Community Action Program | Chariton | Iowa | 50049 | United States |
| Children & Family Resource Center | Hendersonville | North Carolina | 28792 | United States |
| Carolina Health Centers | Greenwood | South Carolina | 29646 | United States |
| Newport News | Newport News | Virginia | 23607 | United States |
| 15354371 | Background | Moses-Kolko EL, Roth EK. Antepartum and postpartum depression: healthy mom, healthy baby. J Am Med Womens Assoc (1972). 2004 Summer;59(3):181-91. |
| 17370048 | Background | Segre LS, O'Hara MW, Arndt S, Stuart S. The prevalence of postpartum depression: the relative significance of three social status indices. Soc Psychiatry Psychiatr Epidemiol. 2007 Apr;42(4):316-21. doi: 10.1007/s00127-007-0168-1. Epub 2007 Feb 13. |
| 15234824 | Background | Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006. |
| 18020817 | Background | Beebe B, Jaffe J, Buck K, Chen H, Cohen P, Blatt S, Kaminer T, Feldstein S, Andrews H. Six-week postpartum maternal self-criticism and dependency and 4-month mother-infant self- and interactive contingencies. Dev Psychol. 2007 Nov;43(6):1360-76. doi: 10.1037/0012-1649.43.6.1360. |
| 12724245 | Background | Murray L, Cooper PJ, Wilson A, Romaniuk H. Controlled trial of the short- and long-term effect of psychological treatment of post-partum depression: 2. Impact on the mother-child relationship and child outcome. Br J Psychiatry. 2003 May;182:420-7. |
| 20662125 | Background | National Research Council (US) and Institute of Medicine (US) Committee on the Prevention of Mental Disorders and Substance Abuse Among Children, Youth, and Young Adults: Research Advances and Promising Interventions; O'Connell ME, Boat T, Warner KE, editors. Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32775/ |
| Background | American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders: DSM-5. ManMag; 2003. |
| 15932842 | Background | Howell EA, Mora PA, Horowitz CR, Leventhal H. Racial and ethnic differences in factors associated with early postpartum depressive symptoms. Obstet Gynecol. 2005 Jun;105(6):1442-50. doi: 10.1097/01.AOG.0000164050.34126.37. |
| 19001135 | Background | Mora PA, Bennett IM, Elo IT, Mathew L, Coyne JC, Culhane JF. Distinct trajectories of perinatal depressive symptomatology: evidence from growth mixture modeling. Am J Epidemiol. 2009 Jan 1;169(1):24-32. doi: 10.1093/aje/kwn283. Epub 2008 Nov 10. |
| 15051562 | Background | Bennett HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004 Apr;103(4):698-709. doi: 10.1097/01.AOG.0000116689.75396.5f. |
| 22961387 | Background | Dolbier CL, Rush TE, Sahadeo LS, Shaffer ML, Thorp J; Community Child Health Network Investigators. Relationships of race and socioeconomic status to postpartum depressive symptoms in rural African American and non-Hispanic white women. Matern Child Health J. 2013 Sep;17(7):1277-87. doi: 10.1007/s10995-012-1123-7. |
| 16400535 | Background | Holzman C, Eyster J, Tiedje LB, Roman LA, Seagull E, Rahbar MH. A life course perspective on depressive symptoms in mid-pregnancy. Matern Child Health J. 2006 Mar;10(2):127-38. doi: 10.1007/s10995-005-0044-0. Epub 2006 Jan 7. |
| Background | Schmit S, Schott L, Pavetti L, Matthews H. Effective, Evidence-Based Home Visiting Programs in Every State at Risk if Congress Does Not Extend Funding. 2015;http://www.cbpp.org/research/effective-evidence-based-home-visiting-programs-in-every-state-at-risk-if-congress-does-not. Accessed February 10, 2016. |
| Background | Avellar S, Paulsell D, Sama-Miller E, Grosso PD, Akers L, Kleinman R. Home visiting evidence of effectiveness review: Executive summary. Mathematica Policy Research;2013. |
| Background | U.S. Department of Health and Human Services, Administration for Children and Families, Office of Planning and Evaluation. Depression in the Lives of Early Head Start Families: Research to Practice Brief. 2006; http://www.acf.hhs.gov/programs/opre/resource/depression-in-the-lives-of-early-head-start-families-research-to-practice. Accessed January 15, 2014. Accessed January 15, 2016. |
| Background | U.S. Department of Health and Human Services, Health Resources and Services Administration, Maternal and Child Health Bureau. A Comprehensive Approach for Community-Based Programs to Address Intimate Partner Violence and Perinatal Depression. 2013; http://mchb.hrsa.gov/pregnancyandbeyond/depression/partnerviolence/partnerviolenceandperinataldepression.pdf.Accessed February 10 2016. |
| Background | Prevent Child Abuse America. Healthy Families America Critical Elements. 2001; http://www.healthyfamiliesamerica.org/downloads/critical_elements_rationale.pdf. Accessed January 15, 2016. |
| 20401324 | Background | Ammerman RT, Putnam FW, Bosse NR, Teeters AR, Van Ginkel JB. Maternal Depression in Home Visitation: A Systematic Review. Aggress Violent Behav. 2010 May;15(3):191-200. doi: 10.1016/j.avb.2009.12.002. |
| 19328548 | Background | Ammerman RT, Putnam FW, Altaye M, Chen L, Holleb LJ, Stevens J, Short JA, Van Ginkel JB. Changes in depressive symptoms in first time mothers in home visitation. Child Abuse Negl. 2009 Mar;33(3):127-38. doi: 10.1016/j.chiabu.2008.09.005. Epub 2009 Mar 27. |
| 28640556 | Background | Chazan-Cohen R, Ayoub C, Pan BA, Roggman L, Raikes H, Mckelvey L, Whiteside-Mansell L, Hart A. It takes time: Impacts of Early Head Start that lead to reductions in maternal depression two years later. Infant Ment Health J. 2007 Mar;28(2):151-170. doi: 10.1002/imhj.20127. |
| 16240078 | Background | Tandon SD, Parillo KM, Jenkins C, Duggan AK. Formative evaluation of home visitors' role in addressing poor mental health, domestic violence, and substance abuse among low-income pregnant and parenting women. Matern Child Health J. 2005 Sep;9(3):273-83. doi: 10.1007/s10995-005-0012-8. |
| 27535131 | Background | McFarlane E, Burrell L, Duggan A, Tandon D. Outcomes of a Randomized Trial of a Cognitive Behavioral Enhancement to Address Maternal Distress in Home Visited Mothers. Matern Child Health J. 2017 Mar;21(3):475-484. doi: 10.1007/s10995-016-2125-7. |
| 23793487 | Background | Tandon SD, Leis JA, Mendelson T, Perry DF, Kemp K. Six-month outcomes from a randomized controlled trial to prevent perinatal depression in low-income home visiting clients. Matern Child Health J. 2014 May;18(4):873-81. doi: 10.1007/s10995-013-1313-y. |
| 29766470 | Background | Tandon SD, Ward EA, Hamil JL, Jimenez C, Carter M. Perinatal depression prevention through home visitation: a cluster randomized trial of mothers and babies 1-on-1. J Behav Med. 2018 Oct;41(5):641-652. doi: 10.1007/s10865-018-9934-7. Epub 2018 May 15. |
| 30747971 | Background | US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Grossman DC, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Silverstein M, Simon MA, Tseng CW, Wong JB. Interventions to Prevent Perinatal Depression: US Preventive Services Task Force Recommendation Statement. JAMA. 2019 Feb 12;321(6):580-587. doi: 10.1001/jama.2019.0007. |
| 23039777 | Background | McCurdie T, Taneva S, Casselman M, Yeung M, McDaniel C, Ho W, Cafazzo J. mHealth consumer apps: the case for user-centered design. Biomed Instrum Technol. 2012 Fall;Suppl:49-56. doi: 10.2345/0899-8205-46.s2.49. No abstract available. |
| 29456295 | Background | Lyon AR, Koerner K. User-Centered Design for Psychosocial Intervention Development and Implementation. Clin Psychol (New York). 2016 Jun;23(2):180-200. doi: 10.1111/cpsp.12154. Epub 2016 Jun 17. |
| Background | Virzi, R.A., J.F. Sorce, and L.B. Herbert. A comparison of three usability evaluation methods: Heuristic, think-aloud, and performance testing. in Human Factors and Ergonomics Society Annual Meeting. 1993. Los Angeles, CA: Sage Publications. |
| 17286625 | Background | Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res. 2007 Aug;42(4):1758-72. doi: 10.1111/j.1475-6773.2006.00684.x. |
| Background | Fusch, P.I. and L.R. Ness, Are we there yet? Data saturation in qualitative research. Qualitative Report, 2015. 20(9): p. 1408-1416. |
| Background | Guest, G., A. Bunce, and L. Johnson, How many interviews are enough? An experiment with data saturation and variability. Field Methods, 2006. 18(1): p. 59-82. |
| 14587545 | Background | Faulkner L. Beyond the five-user assumption: benefits of increased sample sizes in usability testing. Behav Res Methods Instrum Comput. 2003 Aug;35(3):379-83. doi: 10.3758/bf03195514. |
| 10804897 | Background | DeSantis L, Ugarriza DN. The concept of theme as used in qualitative nursing research. West J Nurs Res. 2000 Apr;22(3):351-72. doi: 10.1177/019394590002200308. |
| Background | Hill, C.E., et al., Consensual qualitative research: An update. Journal of counseling psychology, 2005. 52(2): p. 196. |
| Background | Hill, C.E., B.J. Thompson, and E.N. Williams, A guide to conducting consensual qualitative research. The Counseling Psychologist, 1997. 25(4): p. 517-572. |
| 41994134 | Derived | Tandon D, Hamil J, McBride E, Baez L, Pingeton B, Taple B, Barrera A. Examining the Effectiveness of Mothers and Babies Online Delivered in Home Visiting: A Pilot Randomized Controlled Trial. Res Sq [Preprint]. 2026 Apr 9:rs.3.rs-8991058. doi: 10.21203/rs.3.rs-8991058/v1. |