Abstract
To determine whether pregnant women receiving the Mothers and Babies group–based intervention exhibited greater depressive symptom reductions and fewer new cases of major depression than women receiving usual community-based services, and to examine whether groups run by paraprofessional home visitors and mental health professionals yielded similar depressive symptom reductions and prevention of major depression. Using a cluster-randomized design, 37 home visiting programs were randomized to usual home visiting, Mothers and Babies delivered via home visiting paraprofessionals, or Mothers and Babies delivered via mental health professionals. Baseline assessments were conducted prenatally with follow-up extending to 24 weeks postpartum. Eligibility criteria were ≥ 16 years old, ≤ 33 gestation upon referral, and Spanish/English speaking. Depressive symptoms at 24 weeks postpartum was the primary outcome. Eight hundred seventy-four women were enrolled. Neither intervention arm was superior to usual care in decreasing depressive symptoms across the sample (p = 0.401 home visiting paraprofessional vs. control; p = 0.430 mental health professional vs. control). Post hoc analyses suggest a positive intervention effect for women exhibiting mild depressive symptoms at baseline. We have evidence of non-inferiority, as the model-estimated mean difference in depressive symptoms between intervention arms (0.01 points, 95% CI: −0.79, 0.78) did not surpass our pre-specified margin of non-inferiority of two points. Although we did not find statistically significant differences between intervention and control arms, non-inferiority analyses found paraprofessional home visitors generated similar reductions in depressive symptoms as mental health professionals. Additionally, Mothers and Babies appears to reduce depressive symptoms among women with mild depressive symptoms when delivered by mental health professionals. This trial is registered on ClinicalTrials.gov (initial post: December 1, 2016; identifier: NCT02979444).
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
Data availability
All data are available from the PI upon reasonable request for data access.
References
Abrams LS, Dornig K, Curran L (2009) Barriers to service use for postpartum depression symptoms among low-income ethnic minority mothers in the United States. Qual Health Res 19:535–551. https://doi.org/10.1177/1049732309332794
American Psychiatric Association (2013) Diagnostic and statistical manual of mental disorders, 5th edn. American Psychiatric Association, Washington, DC
Brock RL, O'Hara MW, Segre LS (2017) Depression treatment by non-mental-health providers: incremental evidence for the effectiveness of listening visits. Am J Community Psychol 59:172–183. https://doi.org/10.1002/ajcp.12129
Caille A, Kerry S, Tavernier E, Leyrat C, Eldridge S, Giraudeau B (2016) Timeline cluster: a graphical tool to identify risk of bias in cluster randomised trials. BMJ (Clinical research ed) 354:i4291. https://doi.org/10.1136/bmj.i4291
Catanzaro SJ, Mearns J (1990) Measuring generalized expectancies for negative mood regulation: initial scale development and implications. J Pers Assess 54:546–563. https://doi.org/10.1080/00223891.1990.9674019
Ciolino JD, Diebold A, Jensen JK, Rouleau GW, Koloms KK, Tandon D (2019) Choosing an imbalance metric for covariate-constrained randomization in multiple-arm cluster-randomized trials. Trials 20:293. https://doi.org/10.1186/s13063-019-3324-5
Curry SJ et al (2019) Interventions to prevent perinatal depression: US Preventive Services Task Force recommendation statement. JAMA 321:580–587. https://doi.org/10.1001/jama.2019.0007
Dennis CL, Dowswell T (2013) Psychosocial and psychological interventions for preventing postpartum depression. Cochrane Database Syst Rev 2:Cd001134. https://doi.org/10.1002/14651858.CD001134.pub3
Diebold A, Ciolino JD, Johnson JK, Yeh C, Gollan JK, Tandon SD (2020) Comparing fidelity outcomes of paraprofessional and professional delivery of a perinatal depression preventive intervention. Adm Policy Ment Health 47:597–605. https://doi.org/10.1007/s10488-020-01022-5
van Doesum KT, Hosman CM, Riksen-Walraven JM, Hoefnagels C (2007) Correlates of depressed mothers' sensitivity toward their infants: the role of maternal, child, and contextual characteristics. J Am Acad Child Adolesc Psychiatry 46:747–756. https://doi.org/10.1097/CHI.0b013e318040b272
Eaton J et al (2011) Scale up of services for mental health in low-income and middle-income countries. Lancet (London, England) 378:1592–1603. https://doi.org/10.1016/s0140-6736(11)60891-x
Eldridge S, Kerry S, Torgerson DJ (2009) Bias in identifying and recruiting participants in cluster randomised trials: what can be done? BMJ (Clinical research ed) 339:b4006. https://doi.org/10.1136/bmj.b4006
Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD, Williams JM (2007) Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering. Behav Ther 38:234–246. https://doi.org/10.1016/j.beth.2006.08.003
Fuhr DC, Weobong B, Lazarus A, Vanobberghen F, Weiss HA, Singla DR, Tabana H, Afonso E, de Sa A, D'Souza E, Joshi A, Korgaonkar P, Krishna R, Price LSN, Rahman A, Patel V (2019) Delivering the Thinking Healthy Programme for perinatal depression through peers: an individually randomised controlled trial in India. Lancet Psychiatry 6:115–127. https://doi.org/10.1016/s2215-0366(18)30466-8
Gilmore B, McAuliffe E (2013) Effectiveness of community health workers delivering preventive interventions for maternal and child health in low- and middle-income countries: a systematic review. BMC Public Health 13:847. https://doi.org/10.1186/1471-2458-13-847
Grace SL, Evindar A, Stewart DE (2003) The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Women's Ment Health 6:263–274. https://doi.org/10.1007/s00737-003-0024-6
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG (2009) Research electronic data capture (REDCap): a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42:377–381
Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M (2012) Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials 13:120. https://doi.org/10.1186/1745-6215-13-120
Jensen JK, Ciolino JD, Diebold A, Segovia M, Degillio A, Solano-Martinez J, Tandon SD (2018) Comparing the effectiveness of clinicians and paraprofessionals to reduce disparities in perinatal depression via the Mothers and Babies Course: protocol for a cluster-randomized controlled trial. JMIR Res Proc 7:e11624. https://doi.org/10.2196/11624
Josefsson A, Sydsjo G (2007) A follow-up study of postpartum depressed women: recurrent maternal depressive symptoms and child behavior after four years. Arch Women's Ment Health 10:141–145. https://doi.org/10.1007/s00737-007-0185-9
Kanter JW, Mulick PS, Busch AM, Berlin KS, Martell CR (2006) The Behavioral Activation for Depression Scale (BADS): psychometric properties and factor structure. J Psychopathol Behav Assess 29:191–202. https://doi.org/10.1007/s10862-006-9038-5
Kanter JW, Rusch LC, Busch AM, Sedivy SK (2009) Validation of the Behavioral Activation for Depression Scale (BADS) in a community sample with elevated depressive symptoms. J Psychopathol Behav Assess 31:36–42
Kieffer EC, Caldwell CH, Welmerink DB, Welch KB, Sinco BR, Guzman JR (2013) Effect of the healthy MOMs lifestyle intervention on reducing depressive symptoms among pregnant Latinas. Am J Community Psychol 51:76–89. https://doi.org/10.1007/s10464-012-9523-9
Le HN, Muñoz RF (1998) The Maternal Mood Screener (MMS) San Francisco: Unpublished questionnaire, University of California
Leis JA, Mendelson T, Perry DF, Tandon SD (2011) Perceptions of mental health services among low-income, perinatal African-American women. Womens Health Issues 21:314–319. https://doi.org/10.1016/j.whi.2011.03.005
McFarlane E, Burrell L, Duggan A, Tandon D (2017) Outcomes of a randomized trial of a cognitive behavioral enhancement to address maternal distress in home visited mothers. Matern Child Health J 21:475–484. https://doi.org/10.1007/s10995-016-2125-7
Moehler E, Brunner R, Wiebel A, Reck C, Resch F (2006) Maternal depressive symptoms in the postnatal period are associated with long-term impairment of mother-child bonding. Arch Women's Ment Health 9:273–278. https://doi.org/10.1007/s00737-006-0149-5
Morrell CJ, Slade P, Warner R, Paley G, Dixon S, Walters SJ, Brugha T, Barkham M, Parry GJ, Nicholl J (2009) Clinical effectiveness of health visitor training in psychologically informed approaches for depression in postnatal women: pragmatic cluster randomised trial in primary care. BMJ (Clinical research ed) 338:a3045. https://doi.org/10.1136/bmj.a3045
Muñoz RF, le HN, Ippen CG, Diaz MA, Urizar GG Jr, Soto J, Mendelson T, Delucchi K, Lieberman AF (2007) Prevention of postpartum depression in low-income women: development of the Mamás y Bebés/mothers and babies course. Cogn Behav Pract 14:70–83
Murray L, Arteche A, Fearon P, Halligan S, Croudace T, Cooper P (2010) The effects of maternal postnatal depression and child sex on academic performance at age 16 years: a developmental approach. J Child Psychol Psychiatry 51:1150–1159. https://doi.org/10.1111/j.1469-7610.2010.02259.x
Murray L, Arteche A, Fearon P, Halligan S, Goodyer I, Cooper P (2011) Maternal postnatal depression and the development of depression in offspring up to 16 years of age. J Am Acad Child Adolesc Psychiatry 50:460–470. https://doi.org/10.1016/j.jaac.2011.02.001
National Home Visiting Resource Center (2019) 2019 Home Visiting Yearbook. Arlington, VA: James Bell Associates and the Urban Institute https://nhvrcorg/yearbook/2019-yearbook/ Assessed 30 September 2020
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 (2009) In: O'Connell ME, Boat T, Warner KE (eds) Preventing mental, Emotional, and behavioral disorders among young people: progress and possibilities. National Academies Press, US
Nylen KJ, O'Hara MW, Brock R, Moel J, Gorman L, Stuart S (2010) Predictors of the longitudinal course of postpartum depression following interpersonal psychotherapy. J Consult Clin Psychol 78:757–763. https://doi.org/10.1037/a0020623
O'Hara MW, McCabe JE (2013) Postpartum depression: current status and future directions. Annu Rev Clin 9:379–407. https://doi.org/10.1146/annurev-clinpsy-050212-185612
O'Hara MW, Swain AM (1996) Rates and risk of postpartum depression-a meta-analysis. Int Rev Psychiatry 8:37–54
Pearson RM, Bornstein MH, Cordero M, Scerif G, Mahedy L, Evans J, Abioye A, Stein A (2016) Maternal perinatal mental health and offspring academic achievement at age 16: the mediating role of childhood executive function. J Child Psychol Psychiatry 57:491–501. https://doi.org/10.1111/jcpp.12483
Rahman A, Malik A, Sikander S, Roberts C, Creed F (2008) Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet 372:902–909. https://doi.org/10.1016/S0140-6736(08)61400-2
Rasmussen M-LH, Strøm M, Wohlfahrt J, Videbech P, Melbye M (2017) Risk, treatment duration, and recurrence risk of postpartum affective disorder in women with no prior psychiatric history: a population-based cohort study. PLoS Med 14:e1002392-e1002392. https://doi.org/10.1371/journal.pmed.1002392
Rich-Edwards JW, Kleinman K, Abrams A, Harlow BL, McLaughlin TJ, Joffe H, Gillman MW (2006) Sociodemographic predictors of antenatal and postpartum depressive symptoms among women in a medical group practice. J Epidemiol Community Health 60:221–227. https://doi.org/10.1136/jech.2005.039370
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 (2003) 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 54:573–583
Sama-Miller E, Akers L, Mraz-Esposito A, Zukiewicz M, Avellar S, Paulsell D, Del Grosso P (2017) Home visiting evidence of effectiveness review: executive summary. U.S. Department of Health and Human Services, Washington, DC
SAS Institute Inc (2008) The SAS system for windows, version 9 vol computer software. SAS Institute Inc, Cary, NC
Seidman G, Atun R (2017) Does task shifting yield cost savings and improve efficiency for health systems? A systematic review of evidence from low-income and middle-income countries. Hum Resour Health 15:29. https://doi.org/10.1186/s12960-017-0200-9
Sherbourne CD, Stewart AL (1991) The MOS social support survey. Soc Sci Med (1982) 32:705–714
Sikander S, Ahmad I, Atif N, Zaidi A, Vanobberghen F, Weiss HA, Nisar A, Tabana H, Ain QU, Bibi A, Bilal S, Bibi T, Liaqat R, Sharif M, Zulfiqar S, Fuhr DC, Price LSN, Patel V, Rahman A (2019) Delivering the Thinking Healthy Programme for perinatal depression through volunteer peers: a cluster randomised controlled trial in Pakistan. Lancet Psychiatry 6:128–139. https://doi.org/10.1016/s2215-0366(18)30467-x
Sohr-Preston SL, Scaramella LV (2006) Implications of timing of maternal depressive symptoms for early cognitive and language development. Clin Child Fam Psychol Rev 9:65–83. https://doi.org/10.1007/s10567-006-0004-2
Tandon SD, Perry DF, Mendelson T, Kemp K, Leis JA (2011) Preventing perinatal depression in low-income home visiting clients: a randomized controlled trial. J Consult Clin Psychol 79:707–712. https://doi.org/10.1037/a0024895
Tandon SD, Leis JA, Mendelson T, Perry DF, Kemp K (2014) Six-month outcomes from a randomized controlled trial to prevent perinatal depression in low-income home visiting clients. Matern Child Health J 18:873–881. https://doi.org/10.1007/s10995-013-1313-y
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 (2004) 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 34:73–82
Turner EL, Li F, Gallis JA, Prague M, Murray DM (2017) Review of recent methodological developments in group-randomized trials: part 1-design. Am J Public Health 107:907–915. https://doi.org/10.2105/ajph.2017.303706
Vázquez FL, Muñoz RF, Blanco V, López M (2008) Validation of Muñoz's mood screener in a nonclinical Spanish population. Eur J Psychol Assess 24:57–64
World Health Organization (2008) Task shifting: global recommendations and guidelines. WHO Document Production Services, Geneva, Switzerland https://www.who.int/healthsystems/TTR-TaskShifting.pdf?ua=1. Accessed 30 September 2020
Acknowledgements
Research reported in this manuscript was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (AD-1507-31473). The authors would like to thank members of our Operations Team (Sarah Allen PhD, Sara Barrera MA, Alma Cuevas, Katrina Cunningham, Linda Delimata MS LCPC, Jacqueline Gollan PhD, Captoria Porter, Maria Roman, and Lesley Schwartz LCSW ACSW) for their guidance related to study implementation throughout this research project.
Code availability
Not applicable.
Funding
This study was supported by contract #AD-1507-31473 from the Patient Centered Outcomes Research Institute (PCORI) [PI: Darius Tandon].
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Ethics approval
This cluster-randomized trial has been approved by the Institutional Review Board Office of Northwestern University (STU00203761) and was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
Consent to participate
Written informed consent was received by all study participants in the trial.
Consent for publication
All authors have reviewed the manuscript prior to its submission for publication.
Conflict of interest
Darius Tandon has received research grants from the Patient Centered Outcomes Research Institute (PCORI).
Disclaimer
The views, statements, and opinions in this manuscript are solely the responsibility of the authors and do not necessarily represent the views of the PCORI, its Board of Governors or Methodology Committee.
Additional information
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary Information
ESM 1
(PDF 74 kb)
Rights and permissions
About this article
Cite this article
Tandon, S.D., Johnson, J.K., Diebold, A. et al. Comparing the effectiveness of home visiting paraprofessionals and mental health professionals delivering a postpartum depression preventive intervention: a cluster-randomized non-inferiority clinical trial. Arch Womens Ment Health 24, 629–640 (2021). https://doi.org/10.1007/s00737-021-01112-9
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00737-021-01112-9