Internet-based behavioural activation to improve depressive symptoms and prevent child abuse in postnatal women (SmartMama): a protocol for a pragmatic randomized controlled trial

Abstract

Background Child abuse and postnatal depression are two public health problems that often co-occur, with rates of childhood maltreatment highest during the first year of life. Internet-based behavioural activation (iBA) therapy has demonstrated its efficacy for improving postnatal depression. No study has examined whether the iBA program is also effective at preventing child abuse. This study aims to investigate whether iBA improves depressive symptoms among mothers and prevents abusive behaviours towards children in postpartum mothers in a randomized controlled trial, stratifying on depressive mood status. The study also evaluates the implementation aspects of the program, including how users, medical providers, and managers perceive the program in terms of acceptability, appropriateness, feasibility, and harm done. Methods The study is a non-blinded, stratified randomized controlled trial. Based on cut-off scores validated on Japanese mothers, participants will be stratified to either a low Edinburgh Postnatal Depression Scale (EPDS) group, (EPDS 0–8 points) or a high EPDS group (EPDS ≥9 points). A total of 390 postnatal women, 20 years or older, who have given birth within 10 weeks and have regular internet-access will be recruited at two hospitals. Participants will be randomly assigned to either treatment, with treatment as usual (TAU) or through intervention groups. The TAU group receives 12 weekly iBA sessions with online assignments and feedback from trained therapists. Co-primary outcomes are maternal depressive symptoms (EPDS) and psychological aggression toward children (Conflict Tactic Scale 1) at the 24-week follow-up survey. Secondary outcomes include maternal depressive symptoms, parental stress, bonding relationship, quality of life, maternal health care use, and paediatric outcomes such as physical development, preventive care attendance, and health care use. The study will also investigate the implementation outcomes of the program. Discussion The study investigates the effectiveness of the iBA program for maternal depressive symptoms and psychological aggression toward children, as well as implementation outcomes, in a randomized-controlled trial. The iBA may be a potential strategy for improving maternal postnatal depression and preventing child abuse. Trial registration The study protocol (issue date: 2019-Mar-01, original version 2019005NI-00) was registered at the UMIN Clinical Trial Registry (UMIN-CTR: ID UMIN 000036864).

Usefulness of Implementation Outcome Scales for Digital Mental Health (iOSDMH): Experiences from Six Randomized Controlled Trials

“…Table 1 presents the study characteristics and completion rates of the RCTs. These six trials were registered and/or the protocols were published elsewhere [ 15 , 16 , 17 , 18 , 19 , 20 ]. Table 1 also presents the time points at which the iOSDMH was measured in each study.…”

“…Study 5 was a video-based gatekeeper program for students to prevent suicide of their peers. Study 6 was a web-based behavioral activation therapy (BA) intervention with a writing exercise for postnatal women [ 19 ].…”

Educational interventions to prevent paediatric abusive head trauma in babies younger than one year old: A systematic review and meta-analyses

“…Of the six NRSs, three were state/region-wide controlled before-and-after (CBA) studies (Dias, Rottmund, Cappos, et al, 2017;Vinchon, Rakza, Karnoub, & Gobert, 2020;Zolotor, Runyan, Shanahan, et al, 2015), two were case-control studies (Bechtel et al, 2020;Keenan & Leventhal, 2010), and one was a cohort study (Fujiwara, Isumi, Sampei, Yamada, & Miyazaki, 2020b). Of the remaining nine; four (ChiCtr, 2019; JPRN-UMIN000038940, 2020; NCT04568538, 2020; NCT04608877, 2021) were trial registry records of ongoing RCTs, one RCT registry record (JPRN-UMIN000012445, n.d.) was for a completed RCT which had not yet published results, two published RCT protocols (Cook, Seymour, Giallo, et al, 2015;Obikane, Baba, Shinozaki, et al, 2021) had not published esults, and two studies did not report any of our outcomes of interest (Fig. 1) (Lopes, 2017;Lopes, Gorni, Mattar, & de Albuquerque Williams, 2018).…”

“…Ongoing and unpublished studies (all study designs) are presented in Appendix 4 Table S1. Nine studies were conducted in the USA (Barr et al, 2009b;Bechtel et al, 2020;Cala et al, 2020;Dias et al, 2017;Groisberg et al, 2020;Keenan & Leventhal, 2010;McRury & Zolotor, 2010;NCT04608877, 2021;Zolotor et al, 2015), six in Japan (JPRN-UMIN000012445, n.d.; Fujiwara et al, 2012;Fujiwara et al, 2020a;Fujiwara et al, 2020b;JPRN-UMIN000038940, 2020;Obikane et al, 2021), two in Canada (Barr et al, 2009a;Lou et al, 2011), two in Iran (Arshadi et al, n. d.;Bishe et al, 2020), two in Brazil (Lopes, 2017;, and one in France (Vinchon et al, 2020), Australia (Cook et al, 2015), Turkey (NCT04568538, 2020), and China (ChiCtr, 2019). The intervention was delivered in a hospital setting in eight studies (Arshadi et al, n.d.;Dias et al, 2017;Fujiwara et al, 2020a;Groisberg et al, 2020;Keenan & Leventhal, 2010;NCT04608877, 2021;Vinchon et al, 2020;Zolotor et al, 2015), at home in eight studies (Barr et al, 2009a;Barr et al, 2009b;Bishe et al, 2020;Cook et al, 2015;Fujiwara et al, 2012;Fujiwara et al, 2020b;McRury & Zolotor, 2010;Obikane et al, 2021), in hospital and/or at home in two studies (Cala et al, 2020;…”

“…Seven studies (Barr et al, 2009a;Barr et al, 2009b;Fujiwara et al, 2012;Fujiwara et al, 2020a;Groisberg et al, 2020;Lou et al, 2011;Zolotor et al, 2015) investigated the proprietary intervention "Period of PURPLE Crying", compared with standard care (with or without alternative education on child safety). The following proprietary interventions were assessed by one study each: "The Happiest Baby" (McRury & Zolotor, 2010), the "Cry Baby" (Cook et al, 2015), the "SmartMama" (Obikane et al, 2021), the "Crying plan" (Vinchon et al, 2020), and the "Take 5 safety plan" (Bechtel et al, 2020). The remaining studies did not specify a proprietary intervention name.…”