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

Jessica K Jensen, Jody D Ciolino, Alicia Diebold, Melissa Segovia, Aria Degillio, Jesus Solano-Martinez, S Darius Tandon, Jessica K Jensen, Jody D Ciolino, Alicia Diebold, Melissa Segovia, Aria Degillio, Jesus Solano-Martinez, S Darius Tandon

Abstract

Background: Postpartum depression is highly prevalent in low-income women and has significant health and mental health effects on mother and child. Home visiting (HV) programs provide services to large numbers of perinatal women in the United States and are a logical setting for delivering mental health services. Although there are interventions that reduce the risk of developing postpartum depression among low-income women, none have used nonhealth or nonmental health professionals as interventionists.

Objective: This study aimed to outline the protocol of a cluster randomized trial funded by the Patient-Centered Outcomes Research Institute that evaluates whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care. It will also examine if MB, when led by home visitors, is not inferior to MB delivered by mental health professionals (MHPs). MB has previously demonstrated efficacy when delivered by MHPs, and pilot work indicated promising results using home visitors to deliver the intervention.

Methods: A cluster randomized trial is being conducted with 38 HV programs. Sixteen HV programs will deliver MB using MHPs, 16 will deliver MB using paraprofessional home visitors, and 6 will deliver usual HV services. The study employs a modified covariate-constrained randomization design at the site level. We anticipate recruiting 933 women aged ≥16 years enrolled in HV programs, who are 33 or more weeks' gestation and speak either English or Spanish. Women in the 2 intervention arms will receive the 6-session MB group intervention. Baseline, postintervention, 12-week postpartum, and 24-week postpartum assessments will be conducted to assess client outcomes. The primary outcome will be the change in Quick Inventory of Depressive Symptomatology Self-Report 16 scores from baseline to 24-week follow-up. Secondary outcomes associated with core MB content will also be examined. Semistructured interviews will be conducted with home visitors and MHPs who are group facilitators and 90 study participants to gain data on intervention successes and challenges. Analyses will proceed at the participant level. Primary analyses for depressive symptoms score at 24 weeks postpartum will involve a linear mixed model, controlling for baseline symptoms and other covariates, and random effects to account for clustering.

Results: We have recruited 838 women through the end of August 2018. Recruitment will be completed at the end of September 2018.

Conclusions: There is considerable potential to disseminate MB to HV programs throughout the United States. Should our results demonstrate home visitor efficacy when compared with usual care and/ noninferiority between home visitors and MHPs in improving mental health outcomes, no additional financial resources would be required for the existing HV staff to implement MB. Should this study determine that home visitors are less effective than MHPs, we will generate more wide-scale evidence on MB effectiveness when led by MHPs.

Trial registration: ClinicalTrials.gov NCT02979444; https://ichgcp.net/clinical-trials-registry/NCT02979444 (Archived by Webcite at http://www.webcitation.org/archive.php).

International registered report identifier (irrid): PRR1-10.2196/11624.

Keywords: community health; depression; postpartum; pregnancy; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: None declared.

©Jessica K Jensen, Jody D Ciolino, Alicia Diebold, Melissa Segovia, Aria Degillio, Jesus Solano-Martinez, S Darius Tandon. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 20.11.2018.

Figures

Figure 1
Figure 1
Margin of noninferiority (NI). HV: home visiting; QIDS: Quick Inventory of Depressive Symptomatology.

References

    1. 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.
    1. O'hara MW, Swain AM. Rates and risk of postpartum depression—a meta-analysis. Int Rev Psychiatry. 2009 Jul 11;8(1):37–54. doi: 10.3109/09540269609037816.
    1. Rich-Edwards JW, Kleinman K, Abrams A, Harlow BL, McLaughlin TJ, Joffe H, Gillman MW. Sociodemographic predictors of antenatal and postpartum depressive symptoms among women in a medical group practice. J Epidemiol Community Health. 2006 Mar;60(3):221–7. doi: 10.1136/jech.2005.039370.
    1. 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.
    1. Leis JA, Mendelson T, Perry DF, Tandon SD. Perceptions of mental health services among low-income, perinatal African-American women. Womens Health Issues. 2011;21(4):314–9. doi: 10.1016/j.whi.2011.03.005.
    1. Vericker T, Macomber J, Golden O. The Urban Institute. Infants of depressed mothers living in poverty: opportunities to identify and serve .
    1. van Doesum KT, Hosman CM, Riksen-Walraven JM, Hoefnagels C. Correlates of depressed mothers' sensitivity toward their infants: the role of maternal, child, and contextual characteristics. J Am Acad Child Adolesc Psychiatry. 2007 Jun;46(6):747–56. doi: 10.1097/CHI.0b013e318040b272.
    1. Grace SL, Evindar A, Stewart DE. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Womens Ment Health. 2003 Nov;6(4):263–74. doi: 10.1007/s00737-003-0024-6.
    1. Sohr-Preston SL, Scaramella LV. Implications of timing of maternal depressive symptoms for early cognitive and language development. Clin Child Fam Psychol Rev. 2006 Mar;9(1):65–83. doi: 10.1007/s10567-006-0004-2.
    1. Dennis C, 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.
    1. Dennis CL, Hodnett E, Kenton L, Weston J, Zupancic J, Stewart DE, Kiss A. Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial. BMJ. 2009;338:a3064.
    1. Olds DL, Robinson J, O'Brien R, Luckey DW, Pettitt LM, Henderson CR, Ng RK, Sheff KL, Korfmacher J, Hiatt S, Talmi A. Home visiting by paraprofessionals and by nurses: a randomized, controlled trial. Pediatrics. 2002 Sep;110(3):486–96.
    1. 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.
    1. Huybrechts KF, Palmsten K, Mogun H, Kowal M, Avorn J, Setoguchi-Iwata S, Hernández-Díaz S. National trends in antidepressant medication treatment among publicly insured pregnant women. Gen Hosp Psychiatry. 2013;35(3):265–71. doi: 10.1016/j.genhosppsych.2012.12.010.
    1. Paris R, Dubus N. Staying connected while nurturing an infant: a challenge of new motherhood. Fam Relat. 2005 Jan 19;54(1):72–83. doi: 10.1111/j.2040-1124.2010.00046.x. doi: 10.1111/j.0197-6664.2005.00007.x.
    1. Ammerman RT, Putnam FW, Stevens J, Bosse NR, Short JA, Bodley AL, Van Ginkel JB. An open trial of in-home CBT for depressed mothers in home visitation. Matern Child Health J. 2011 Nov;15(8):1333–41. doi: 10.1007/s10995-010-0691-7.
    1. Ammerman RT, Putnam FW, Altaye M, Stevens J, Teeters AR, Van Ginkel JB. A clinical trial of in-home CBT for depressed mothers in home visitation. Behav Ther. 2013 Sep;44(3):359–72. doi: 10.1016/j.beth.2013.01.002.
    1. Beeber LS, Holditch-Davis D, Perreira K, Schwartz TA, Lewis V, Blanchard H, Canuso R, Goldman BD. Short-term in-home intervention reduces depressive symptoms in early head start Latina mothers of infants and toddlers. Res Nurs Health. 2010 Feb;33(1):60–76. doi: 10.1002/nur.20363.
    1. Segre LS, Brock RL, O'Hara MW. Depression treatment for impoverished mothers by point-of-care providers: a randomized controlled trial. J Consult Clin Psychol. 2015 Apr;83(2):314–24. doi: 10.1037/a0038495.
    1. 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.
    1. 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.
    1. 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.
    1. Substance Abuse and Mental Health Services Administration (SAMHSA) National registry of evidence-based programs and practices. 2018. .
    1. Tandon S, Perry D, Mendelson T, Kemp K. Results from a pilot study using paraprofessional home visitors to deliver a postpartum depression preventive intervention. Unpublished data. 2018
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377–81. doi: 10.1016/j.jbi.2008.08.010.
    1. Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M. Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials. 2012 Aug 01;13:120. doi: 10.1186/1745-6215-13-120.
    1. Zhao W, Hill MD, Palesch Y. Minimal sufficient balance-a new strategy to balance baseline covariates and preserve randomness of treatment allocation. Stat Methods Med Res. 2015 Dec;24(6):989–1002. doi: 10.1177/0962280212436447.
    1. 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 01;54(5):573–83.
    1. Boivin M, Pérusse D, Dionne G, Saysset V, Zoccolillo M, Tarabulsy GM, Tremblay N, Tremblay RE. The genetic-environmental etiology of parents' perceptions and self-assessed behaviours toward their 5-month-old infants in a large twin and singleton sample. J Child Psychol Psychiatry. 2005 Jun;46(6):612–30. doi: 10.1111/j.1469-7610.2004.00375.x.
    1. 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.
    1. Vázquez FL, Muñoz RF, Blanco V, López M. Validation of Muñoz's Mood Screener in a nonclinical Spanish population. Eur J Psychol Assess. 2008 Jan;24(1):57–64. doi: 10.1027/1015-5759.24.1.57.
    1. Kanter JW, Mulick PS, Busch AM, Berlin KS, Martell CR. The Behavioral Activation for Depression Scale (BADS): psychometric properties and factor structure. J Psychopathol Behav Assess. 2006 Oct 25;29(3):191–202. doi: 10.1007/s10862-006-9038-5.
    1. MacPhillamy DJ, Lewinsohn PM. The pleasant events schedule: studies on reliability, validity, and scale intercorrelation. J Consult Clin Psychol. 1982;50(3):363–380. doi: 10.1037/0022-006X.50.3.363.
    1. Catanzaro SJ, Mearns J. Measuring generalized expectancies for negative mood regulation: initial scale development and implications. J Pers Assess. 1990;54(3-4):546–63. doi: 10.1080/00223891.1990.9674019.
    1. Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705–14.
    1. Teasdale JD, Moore RG, Hayhurst H, Pope M, Williams S, Segal ZV. Metacognitive awareness and prevention of relapse in depression: empirical evidence. J Consult Clin Psychol. 2002 Apr;70(2):275–87.
    1. Crane DR, Middleton KC, Bean RA. Establishing criterion scores for the Kansas Marital Satisfaction Scale and the Revised Dyadic Adjustment Scale. Am J Fam Ther. 2000 Jan;28(1):53–60. doi: 10.1080/019261800261815.
    1. Diener E, Wirtz D, Tov W, Kim-Prieto C, Choi D, Oishi S, Biswas-Diener R. New well-being measures: short scales to assess flourishing and positive and negative feelings. Soc Indic Res. 2009 May 28;97(2):143–156. doi: 10.1007/s11205-009-9493-y.
    1. Cohen S, Hoberman HM. Positive events and social supports as buffers of life change stress. J Appl Social Pyschol. 1983 Apr;13(2):99–125. doi: 10.1111/j.1559-1816.1983.tb02325.x.
    1. SAS Institute Inc. 2012. [2018-10-30]. SAS 9.4
    1. R Core Team. 2011. [2018-10-30]. R: A language and environment for statistical computing
    1. Hintze J. NCSS, LLC. 2011. [2018-10-30]. PASS 11
    1. Raab GM, Butcher I. Balance in cluster randomized trials. Stat Med. 2001 Feb 15;20(3):351–65.
    1. Turner EL, Li F, Gallis JA, Prague M, Murray DM. Review of recent methodological developments in group-randomized trials: part 1-design. Am J Public Health. 2017 Dec;107(6):907–915. doi: 10.2105/AJPH.2017.303706.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe