type: article
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.'
affiliation: 'Jensen, JK (Corresponding Author), Northwestern Univ, Ctr Community
  Hlth, Inst Publ Hlth \& Med, Feinberg Sch Med, 750 N Lake Shore Dr,Suite 680, Chicago,
  IL 60611 USA.

  Jensen, Jessica K.; Diebold, Alicia; Segovia, Melissa; Degillio, Aria; Solano-Martinez,
  Jesus; Tandon, S. Darius, Northwestern Univ, Ctr Community Hlth, Inst Publ Hlth
  \& Med, Feinberg Sch Med, 750 N Lake Shore Dr,Suite 680, Chicago, IL 60611 USA.

  Ciolino, Jody D., Northwestern Univ, Dept Prevent Med, Feinberg Sch Med, Chicago,
  IL 60611 USA.'
article-number: e11624
author: Jensen, Jessica K. and Ciolino, Jody D. and Diebold, Alicia and Segovia, Melissa
  and Degillio, Aria and Solano-Martinez, Jesus and Tandon, S. Darius
author-email: jessica.jensen@northwestern.edu
author_list:
- family: Jensen
  given: Jessica K.
- family: Ciolino
  given: Jody D.
- family: Diebold
  given: Alicia
- family: Segovia
  given: Melissa
- family: Degillio
  given: Aria
- family: Solano-Martinez
  given: Jesus
- family: Tandon
  given: S. Darius
da: '2023-09-28'
doi: 10.2196/11624
files: []
issn: 1929-0748
journal: JMIR RESEARCH PROTOCOLS
keywords: 'depression; postpartum; pregnancy; randomized controlled trial;

  community health'
keywords-plus: 'IN-HOME CBT; LOW-INCOME; POSTPARTUM DEPRESSION; SYMPTOMS; SCALE;

  INFANTS; PERCEPTIONS; OUTCOMES; EVENTS'
language: English
month: NOV
number: '11'
number-of-cited-references: '44'
orcid-numbers: 'Johnson, Jessica/0000-0001-9482-7225

  Diebold, Alicia/0000-0002-1085-9105

  Tandon, Darius/0000-0002-3243-903X

  Solano-Martinez, Jesus/0000-0002-3826-6408'
papis_id: eac6fc92d0d106077ef82f2aaaa4fcf3
ref: Jensen2018comparingeffectivene
times-cited: '11'
title: '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'
unique-id: WOS:000452201800011
usage-count-last-180-days: '0'
usage-count-since-2013: '2'
volume: '7'
web-of-science-categories: 'Health Care Sciences \& Services; Public, Environmental
  \& Occupational

  Health'
year: '2018'