Development, Feasibility and Acceptability of Fathers and Babies (FAB): A Pilot Study

Depression Clinical Trial

Official title:

Integrating Text Messages Into the Mothers and Babies Course to Address Depression in Low-Income Women and Their Partners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427528
• Other study ID #: STU00203918-B
• Secondary ID: 1R21MD011320-01
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: September 4, 2020

Study information

• Verified date: July 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

During this project the investigators will develop and pilot test a companion intervention for fathers (Fathers and Babies-FAB), to supplement the Mothers and Babies Course (MB) that provides stress and mood management tools for home visiting clients. Focus groups with prior study participants, their male partners, and home visiting staff will be used to develop the FAB curriculum and protocol. FAB text messages aim to improve the mental health of the male partner and help him support his partner's mental health. Feasibility, acceptability, and outcome measures will be supplemented with assessments of fathers' mental health and partners' relationships. Participant assessments will be conducted at baseline, 3 and 6 months in this uncontrolled pilot study. The public health significance and innovation of this project is substantial. If the investigators are able to integrate MB-TXT and MB-DAD into home visiting programs and generate improved mental health outcomes for home visiting clients and their partners, the investigators will be prepared to replicate this intervention across home visiting programs nationally at a time when home visitation as a service delivery model for families with infants and young children is rapidly proliferating through federal funding.

Description:

Enhancements to Mothers and Babies are warranted to address the mental health of both parents, via the home visitation service delivery model where many of the most at-risk families enter into provider-client relationships during their child's infancy and early childhood.

Previous postpartum depression preventive interventions-including MB-have neglected to intervene with partners of pregnant women, despite the growing recognition that paternal depression also exerts influence on children's social-emotional development and occurs in a similar time-frame. Thus, in an otherwise successful intervention, these limitations-mixed success in improving hypothesized intervention mechanisms and limited engagement of fathers-may mitigate intervention efficacy. Paternal depression is hypothesized to mediate the relationship between MB modules and maternal mental health outcomes.

This study addresses this limitation. The investigators will collaborate with 10-12 home visiting (HV) programs serving primarily low-income families. The investigators will recruit 24 mother-father dyads for an uncontrolled pilot in which mothers will receive MB-TXT and fathers will receive FAB, a pilot curriculum developed using existing materials and data collected via qualitative research with home visiting clients, their partners, and home visiting staff.

Aim 1. To develop and determine the feasibility and acceptability of a) conducting the MB-DAD intervention protocol and b) assessing paternal and dyadic outcomes across two home visiting programs. Focus groups with prior trial participants, their male partners, and home visiting staff will generate information on a) intervention content, b) frequency of contact, and c) relationship to MB materials received by their partner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

English-speaking women >18 years old enrolled in home visiting programs who are in their 1st or 2nd or 3rd Trimester will be eligible for enrollment

Male partners of English-speaking women >18 years old enrolled in home visiting programs who are in their 1st or 2nd or 3rd Trimester will be eligible for enrollment

Note: Both parents/partners are required to participate in this study, not just one or the other.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Perinatal Depression
• Postpartum Depression

Intervention

Behavioral:
• Fathers and Babies (FAB)
The initial FAB session was delivered in person or by phone by the home visitor working with the mother, and lasted 30 min on average. Subsequent sessions were delivered, in-person, via text message with embedded links to online content, or a mix of both in-person and text messages, depending on the preference and availability of the father. Fathers received three to six text messages per FAB session.
• MB 1-on-1 plus TXT
Home visiting clients received the Mothers and Babies with -Text Messages intervention in person during regular scheduled home visits (i.e., MB 1-on-1 plus MB-TXT). After each in person session home visiting clients receive three messages to reinforce skill practice and remind them about their personal projects.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (99)

Abrams LS, Dornig K, Curran L. Barriers to service use for postpartum depression symptoms among low-income ethnic minority mothers in the United States. Qual Health Res. 2009 Apr;19(4):535-51. doi: 10.1177/1049732309332794. — View Citation

Ainsworth M, Blehar M, Waters E. Wall. s.(1978). Patterns of attachment: A psychological study of the strange situation

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders:: DSM-5. ManMag; 2003

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. — View Citation

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. — View Citation

Anderson M. Technology device ownership: 2015. 2015; http://www.pewinternet.org/2015/10/29/technology-device-ownership-2015/. Accessed February 2, 2016.

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

Barlow J, Smailagic N, Huband N, Roloff V, Bennett C. Group-based parent training programmes for improving parental psychosocial health. Cochrane Database Syst Rev. 2014 May 17;(5):CD002020. doi: 10.1002/14651858.CD002020.pub4. Review. — View Citation

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. — View Citation

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. Review. Erratum in: Obstet Gynecol. 2004 Jun;103(6):1344. — View Citation

Bennett IM, Marcus SC, Palmer SC, Coyne JC. Pregnancy-related discontinuation of antidepressants and depression care visits among Medicaid recipients. Psychiatr Serv. 2010 Apr;61(4):386-91. doi: 10.1176/ps.2010.61.4.386. — View Citation

Bowlby J. Attachment and loss. Vol 3: Basic books; 1980

Bronte-Tinkew J, Moore KA, Matthews G, Carrano J. Symptoms of major depression in a sample of fathers of infants sociodemographic correlates and links to father involvement. Journal of family Issues. 2007;28(1):61-99.

Broom MA, Ladley AS, Rhyne EA, Halloran DR. Feasibility and Perception of Using Text Messages as an Adjunct Therapy for Low-Income, Minority Mothers With Postpartum Depression. JMIR Ment Health. 2015 Mar 16;2(1):e4. doi: 10.2196/mental.4074. eCollection 2015 Jan-Mar. — View Citation

Campbell SB, Cohn JF, Flanagan C, Popper S, Meyers T. Course and correlates of postpartum depression during the transition to parenthood. Development and psychopathology. 1992;4(01):29-47

Catanzaro SJ, Greenwood G. Expectancies for negative mood regulation, coping, and dysphoria among college students. Journal of Counseling Psychology. 1994;41(1):34.

Catanzaro SJ, Mearns J. Measuring generalized expectancies for negative mood regulation: initial scale development and implications. J Pers Assess. 1990 Summer;54(3-4):546-63. — View Citation

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. — View Citation

Chronicity of maternal depressive symptoms, maternal sensitivity, and child functioning at 36 months. NICHD Early Child Care Research Network. Dev Psychol. 1999 Sep;35(5):1297-310. — View Citation

Cormick G, Kim NA, Rodgers A, Gibbons L, Buekens PM, Belizán JM, Althabe F. Interest of pregnant women in the use of SMS (short message service) text messages for the improvement of perinatal and postnatal care. Reprod Health. 2012 Aug 6;9:9. — View Citation

Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. — View Citation

Crane DR, Middleton KC, Bean RA. Establishing criterion scores for the Kansas marital satisfaction scale and the revised dyadic adjustment scale. American Journal of Family Therapy. 2000;28(1):53-60.

Cuijpers P, de Graaf R, van Dorsselaer S. Minor depression: risk profiles, functional disability, health care use and risk of developing major depression. J Affect Disord. 2004 Apr;79(1-3):71-9. — View Citation

Davé S, Sherr L, Senior R, Nazareth I. Associations between paternal depression and behaviour problems in children of 4-6 years. Eur Child Adolesc Psychiatry. 2008 Aug;17(5):306-15. doi: 10.1007/s00787-007-0672-6. Epub 2008 Mar 25. — View Citation

Davis RN, Davis MM, Freed GL, Clark SJ. Fathers' depression related to positive and negative parenting behaviors with 1-year-old children. Pediatrics. 2011 Apr;127(4):612-8. doi: 10.1542/peds.2010-1779. Epub 2011 Mar 14. — View Citation

Dennis CL, Chung-Lee L. Postpartum depression help-seeking barriers and maternal treatment preferences: a qualitative systematic review. Birth. 2006 Dec;33(4):323-31. Review. — View Citation

Dennis CL, Dowswell T. Interventions (other than pharmacological, psychosocial or psychological) for treating antenatal depression. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD006795. doi: 10.1002/14651858.CD006795.pub3. Review. — View Citation

Dennis CL, Dowswell T. Psychosocial and psychological interventions for preventing postpartum depression. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD001134. doi: 10.1002/14651858.CD001134.pub3. Review. — View Citation

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. — View Citation

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. — View Citation

Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009 Feb;36(2):165-73. doi: 10.1016/j.amepre.2008.09.040. Review. — View Citation

Fletcher RJ, Feeman E, Garfield C, Vimpani G. The effects of early paternal depression on children's development. Med J Aust. 2011 Dec 19;195(11-12):685-9. — View Citation

Foster CJ, Garber J, Durlak JA. Current and past maternal depression, maternal interaction behaviors, and children's externalizing and internalizing symptoms. J Abnorm Child Psychol. 2008 May;36(4):527-37. Epub 2007 Dec 11. — View Citation

Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD, Williams JM. Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering. Behav Ther. 2007 Sep;38(3):234-46. Epub 2007 Apr 24. — View Citation

Garfield CF, Duncan G, Rutsohn J, McDade TW, Adam EK, Coley RL, Chase-Lansdale PL. A longitudinal study of paternal mental health during transition to fatherhood as young adults. Pediatrics. 2014 May;133(5):836-43. doi: 10.1542/peds.2013-3262. Epub 2014 Apr 14. — View Citation

Garfield CF, Isacco A. Fathers and the well-child visit. Pediatrics. 2006 Apr;117(4):e637-45. — View Citation

Garfield CF, Isacco III AJ. Urban fathers' involvement in their child's health and healthcare. Psychology of Men & Masculinity. 2012;13(1):32.

Garfield CF, Lee Y, Kim HN. Paternal and maternal concerns for their very low-birth-weight infants transitioning from the NICU to home. J Perinat Neonatal Nurs. 2014 Oct-Dec;28(4):305-12. doi: 10.1097/JPN.0000000000000021. — View Citation

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. Review. — View Citation

Giallo R, Cooklin A, Nicholson JM. Risk factors associated with trajectories of mothers' depressive symptoms across the early parenting period: an Australian population-based longitudinal study. Arch Womens Ment Health. 2014 Apr;17(2):115-25. doi: 10.1007/s00737-014-0411-1. Epub 2014 Jan 15. — View Citation

Gutierrez-Galve L, Stein A, Hanington L, Heron J, Ramchandani P. Paternal depression in the postnatal period and child development: mediators and moderators. Pediatrics. 2015 Feb;135(2):e339-47. doi: 10.1542/peds.2014-2411. Epub 2015 Jan 5. — View Citation

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. Epub 2006 Jan 7. — View Citation

Horwitz SM, Briggs-Gowan MJ, Storfer-Isser A, Carter AS. Prevalence, correlates, and persistence of maternal depression. J Womens Health (Larchmt). 2007 Jun;16(5):678-91. — View Citation

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. — View Citation

Kannisto KA, Koivunen MH, Välimäki MA. Use of mobile phone text message reminders in health care services: a narrative literature review. J Med Internet Res. 2014 Oct 17;16(10):e222. doi: 10.2196/jmir.3442. Review. — View Citation

Kanter JW, Mulick PS, Busch AM, Berlin KS, Martell CR. The Behavioral Activation for Depression Scale (BADS): psychometric properties and factor structure. Journal of Psychopathology and Behavioral Assessment. 2007;29(3):191-202.

Kanter JW, Rusch LC, Busch AM, Sedivy SK. Validation of the Behavioral Activation for Depression Scale (BADS) in a community sample with elevated depressive symptoms. Journal of Psychopathology and Behavioral Assessment. 2009;31(1):36-42.

Kim HN, Garfield C, Lee YS. Paternal and Maternal Information and Communication Technology Usage as Their Very Low Birth Weight Infants Transition Home From the NICU. International Journal of Human-Computer Interaction. 2015;31(1):44-54.

Kim JJ, La Porte LM, Corcoran M, Magasi S, Batza J, Silver RK. Barriers to mental health treatment among obstetric patients at risk for depression. Am J Obstet Gynecol. 2010 Mar;202(3):312.e1-5. doi: 10.1016/j.ajog.2010.01.004. — View Citation

Le HN, Perry DF, Stuart EA. Randomized controlled trial of a preventive intervention for perinatal depression in high-risk Latinas. J Consult Clin Psychol. 2011 Apr;79(2):135-41. doi: 10.1037/a0022492. — View Citation

Lewinsohn P, Muñoz R, Youngren M, Zeiss A. Control Your Depression. Reducing Depression through Learning Self-Control Techniques, Relaxation Training, Pleasant Activities, Social Skills, Constructed Thinking, Planning Ahead and More. New York: Simon & Schuster Inc; 1986

Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. Epub 2005 May 11. Review. — View Citation

Logsdon MC, Wisner K, Sit D, Luther JF, Wisniewski SR. Depression treatment and maternal functioning. Depress Anxiety. 2011 Nov;28(11):1020-6. doi: 10.1002/da.20892. Epub 2011 Sep 2. — View Citation

Lovejoy MC, Graczyk PA, O'Hare E, Neuman G. Maternal depression and parenting behavior: a meta-analytic review. Clin Psychol Rev. 2000 Aug;20(5):561-92. — View Citation

Madden M. Technology use by different income groups. 2013; http://www.pewinternet.org/2013/05/29/technology-use-by-different-income-groups/. Accessed February 2, 2016.

Mance GA, Mendelson T, Byrd B, Jones J, Tandon D. Utilizing community-based participatory research to adapt a mental health intervention for African American emerging adults. Prog Community Health Partnersh. 2010 Summer;4(2):131-40. doi: 10.1353/cpr.0.0112. — View Citation

Mayberry LJ, Horowitz JA, Declercq E. Depression symptom prevalence and demographic risk factors among U.S. women during the first 2 years postpartum. J Obstet Gynecol Neonatal Nurs. 2007 Nov-Dec;36(6):542-9. — View Citation

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. — View Citation

Meijer JL, Beijers C, van Pampus MG, Verbeek T, Stolk RP, Milgrom J, Bockting CL, Burger H. Predictive accuracy of Edinburgh postnatal depression scale assessment during pregnancy for the risk of developing postpartum depressive symptoms: a prospective cohort study. BJOG. 2014 Dec;121(13):1604-10. doi: 10.1111/1471-0528.12759. Epub 2014 Apr 7. — View Citation

Mendelson T, Leis JA, Perry DF, Stuart EA, Tandon SD. Impact of a preventive intervention for perinatal depression on mood regulation, social support, and coping. Arch Womens Ment Health. 2013 Jun;16(3):211-8. doi: 10.1007/s00737-013-0332-4. Epub 2013 Mar 2. — View Citation

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. — View Citation

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. Review. — View Citation

Muñoz RF, Le H-N, Ippen CG, et al. Prevention of postpartum depression in low-income women: Development of the Mamás y Bebés/Mothers and Babies course. Cognitive and Behavioral Practice. 2007;14(1):70-83

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. — View Citation

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. — View Citation

O'Hara M. Postpartum depression: identification and measurement in a cross-cultural context. Perinatal psychiatry: Use and misuse of the Edinburgh Postnatal Depression Scale. London: Gaskell. 1994:145-168.

O'Hara MW. Postpartum depression: what we know. J Clin Psychol. 2009 Dec;65(12):1258-69. doi: 10.1002/jclp.20644. — View Citation

O'Mahen HA, Flynn HA. Preferences and perceived barriers to treatment for depression during the perinatal period. J Womens Health (Larchmt). 2008 Oct;17(8):1301-9. doi: 10.1089/jwh.2007.0631. — View Citation

Paulson JF, Bazemore SD. Prenatal and postpartum depression in fathers and its association with maternal depression: a meta-analysis. JAMA. 2010 May 19;303(19):1961-9. doi: 10.1001/jama.2010.605. — View Citation

Paulson JF, Keefe HA, Leiferman JA. Early parental depression and child language development. J Child Psychol Psychiatry. 2009 Mar;50(3):254-62. doi: 10.1111/j.1469-7610.2008.01973.x. Epub 2008 Oct 23. — View Citation

Poorman E, Gazmararian J, Parker RM, Yang B, Elon L. Use of text messaging for maternal and infant health: a systematic review of the literature. Matern Child Health J. 2015 May;19(5):969-89. doi: 10.1007/s10995-014-1595-8. Review. — View Citation

Prevent Child Abuse America. Healthy Families America Critical Elements. 2001; http://www.healthyfamiliesamerica.org/downloads/critical_elements_rationale.pdf. Accessed January 15, 2016.

Procidano ME, Heller K. Measures of perceived social support from friends and from family: three validation studies. Am J Community Psychol. 1983 Feb;11(1):1-24. — View Citation

Ramchandani PG, Stein A, O'Connor TG, Heron J, Murray L, Evans J. Depression in men in the postnatal period and later child psychopathology: a population cohort study. J Am Acad Child Adolesc Psychiatry. 2008 Apr;47(4):390-398. doi: 10.1097/CHI.0b013e31816429c2. Review. — View Citation

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. Review. — View Citation

Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. Erratum in: Biol Psychiatry. 2003 Sep 1;54(5):585. — View Citation

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.

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. Epub 2007 Feb 13. — View Citation

Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. — View Citation

Siu AL; US Preventive Services Task Force (USPSTF), Bibbins-Domingo K, Grossman DC, Baumann LC, Davidson KW, Ebell M, García FA, Gillman M, Herzstein J, Kemper AR, Krist AH, Kurth AE, Owens DK, Phillips WR, Phipps MG, Pignone MP. Screening for Depression in Adults: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jan 26;315(4):380-7. doi: 10.1001/jama.2015.18392. — View Citation

Smith MV, Shao L, Howell H, Wang H, Poschman K, Yonkers KA. Success of mental health referral among pregnant and postpartum women with psychiatric distress. Gen Hosp Psychiatry. 2009 Mar-Apr;31(2):155-62. doi: 10.1016/j.genhosppsych.2008.10.002. Epub 2008 Dec 3. — View Citation

Snow K, Thalji L, Derecho A, et al. Early Childhood Longitudinal Study, Birth Cohort (ECLS-B), Preschool Year Data File User's Manual (2005-06)(NCES 2008-024). Washington, DC: National Center for Education Statistics, Institute of Education Sciences, US Department of Education. 2007:1-190.

Soltani H, Furness PJ, Arden MA, McSeveny K, Garland C, Sustar H, Dearden A. Women's and Midwives' Perspectives on the Design of a Text Messaging Support for Maternal Obesity Services: An Exploratory Study. J Obes. 2012;2012:835464. doi: 10.1155/2012/835464. Epub 2012 Jul 26. — View Citation

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. — View Citation

Tandon SD, Mercer CD, Saylor EL, Duggan AK. Paraprofessional home visitors' perspectives on addressing poor mental health, substance abuse, and domestic violence: A qualitative study. Early Childhood Research Quarterly. 2008;23(3):419-428

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. — View Citation

Tandon SD, Parillo KM, Keefer M. Hispanic women's perceptions of patient-centeredness during prenatal care: a mixed-method study. Birth. 2005 Dec;32(4):312-7. — View Citation

Tandon SD, Perry DF, Mendelson T, Kemp K, Leis JA. Preventing perinatal depression in low-income home visiting clients: a randomized controlled trial. J Consult Clin Psychol. 2011 Oct;79(5):707-12. doi: 10.1037/a0024895. — View Citation

Teri L, Lewinsohn P. Modification of the Pleasant and Unpleasant Events Schedules for use with the elderly. J Consult Clin Psychol. 1982 Jun;50(3):444-5. — View Citation

Trivedi MH, Rush AJ, Ibrahim HM, Carmody TJ, Biggs MM, Suppes T, Crismon ML, Shores-Wilson K, Toprac MG, Dennehy EB, Witte B, Kashner TM. The Inventory of Depressive Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation. Psychol Med. 2004 Jan;34(1):73-82. — View Citation

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

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.

U.S. Department of Health and Human Services, Maternal and Child Health Bureau. Women's Health USA 2013. http://mchb.hrsa.gov/whusa13/health-services-utilization/pdf/mhcu.pdf. Accessed October 1.

Vázquez FL, Muñoz RF, Blanco V, López M. Validation of Muñoz's Mood Screener in a nonclinical Spanish population. European Journal of Psychological Assessment. 2008;24(1):57-64.

Verreault N, Da Costa D, Marchand A, Ireland K, Dritsa M, Khalifé S. Rates and risk factors associated with depressive symptoms during pregnancy and with postpartum onset. J Psychosom Obstet Gynaecol. 2014 Sep;35(3):84-91. doi: 10.3109/0167482X.2014.947953. — View Citation

Wagner HR, Burns BJ, Broadhead WE, Yarnall KS, Sigmon A, Gaynes BN. Minor depression in family practice: functional morbidity, co-morbidity, service utilization and outcomes. Psychol Med. 2000 Nov;30(6):1377-90. — View Citation

Waring ME, Moore Simas TA, Xiao RS, Lombardini LM, Allison JJ, Rosal MC, Pagoto SL. Pregnant women's interest in a website or mobile application for healthy gestational weight gain. Sex Reprod Healthc. 2014 Dec;5(4):182-4. doi: 10.1016/j.srhc.2014.05.002. Epub 2014 May 14. — View Citation

Weinberg MK, Tronick EZ, Beeghly M, Olson KL, Kernan H, Riley JM. Subsyndromal depressive symptoms and major depression in postpartum women. Am J Orthopsychiatry. 2001 Jan;71(1):87-97. — View Citation

Wisner KL, Perel JM, Peindl KS, Hanusa BH. Timing of depression recurrence in the first year after birth. J Affect Disord. 2004 Mar;78(3):249-52. — View Citation

* Note: There are 99 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Depressive Symptoms	Beck Depression Inventory-II (BDI-II) (Beck et al., 1988). The BDI-II was used to assess severity of depressive symptoms consistent with DSM-IV symptom criteria. The BDI-II is a 21-item survey, each item asks respondents to indicate on a scale ranging from 0 to 3 the extent to which they endorse different symptoms of depression over the past two weeks with higher scores indicating greater depression severity, with the highest score of 63.; 0-10-considered normal 11-16 Mild mood disturbance 17-20 Borderline clinical depression 21-30 Moderate depression 31-40 Severe depression Over 40 Extreme depression.	Baseline and Post Intervention at 3 and 6 months
Primary	Change in Anxiety	Generalized Anxiety Disorder 7-item Scale (GAD-7) (Spitzer et al., 2006). The GAD-7 is a 7-item survey, each item asks respondents to indicate on a 4-point scale the extent to which they endorse different symptoms of anxiety over the past two weeks with higher scores indicating greater anxiety symptoms. The highest score is 21.; Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety	Baseline and Post Intervention at 3 and 6 months
Primary	Change in Perceived Stress	Perceived Stress Scale 10-item Scale (PSS-10) (Cohen & Williamson, 1988). The PSS-10 is a 10-item survey that asks respondents to indicate on a 5-point scale the extent to which they appraised certain situations as stressful over the past month, with higher scores indicating greater perceived stress. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.; 0-13 are considered low stress Scores ranging from 14-26 are considered moderate stress Scores ranging from 27-40 are considered high perceived stress	Baseline and Post Intervention at 3 and 6 months
Secondary	Change in Social Support Effectiveness	Social Support Effectiveness Questionnaire (SSE-Q) (Rini et al., 2011). The SSE-Q is a 25-item survey that asks respondents to indicate the extent to which their partners provided different types of support in the past three months. The SSE-Q consists of subscales on task support, informational support, emotional support, and negative effects of support. For this study, we calculated a total social support score that summed these four subscales (range 0-80). High scores indicate more effective support. Full scale scores can range from 0 to 80, and each subscale can range from 0 to 20.	Baseline and Post Intervention at 3 and 6 months
Secondary	Instrumental Social Support Support Survey (Cyranowski et al., 2013).	The measure consists of 8 questions and asks respondents to indicate on a 5-point scale the extent to which they have received different types of instrumental support in the last month. Higher scores indicate greater support. We report on the count and percentage of individuals with high instrumental support at each time point.	Baseline and Post Intervention at 3 and 6 months
Secondary	Emotional Support Support (Cyranowski et al., 2013)	NIH Toolbox Emotional Support Support Survey. The survey consists of 8 questions and asks respondents to indicate on a 5-point scale the extent to which they have received different types of emotional support in the last month. Higher scores indicate greater support. We report on the count and percentage of individuals with high emotional support at each time point.	Baseline and Post Intervention at 3 and 6 months