Study design
We registered this systematic review and meta-analysis protocol with the International Prospective Register of Systematic Reviews (PROSPERO, registration number CRD42021266462). This protocol was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) 2015 statement [20] (Additional file 1). The final review will be created according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement [21].
Search strategy
We will perform literature searches with the following electronic databases from their inception onward: MEDLINE, PsycINFO, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL). A draft MEDLINE search strategy developed by one of the authors (KO) is described in Additional file 2. After the MEDLINE strategy is completed, it will be adapted to the subject headings and syntax of the other databases. Our search terms consist of “perinatal,” “intervention program,” “child abuse,” and “randomized controlled trials” (RCTs).
Study records
We will upload the studies collected through electronic and manual searches to Rayyan [22], an Internet-based software program facilitating collaboration among reviewers during the study-selection process. Citations, titles, and abstracts will be uploaded to Rayyan. Duplicates will be removed. Then, full-text screening will be conducted using EndNote [23], a reference management software package.
Eligibility criteria
We will include original studies of RCTs; we will exclude articles that did not report original data (e.g., review, meta-analyses, and commentary papers). We will not impose limits on the publication date. The review will include only full-text, peer-reviewed articles published in the English language. The following participants, interventions, comparisons, outcomes, and study criteria (PICOS) of the studies will be included:
-
(P) Studies with participants who are women during pregnancy and less than one year after childbirth who are at risk of child abuse and neglect (determined to be at risk for any reason, e.g., mental illness, low income, social isolation, drug/alcohol use, smoking, and domestic violence) will be included. No age restrictions will be imposed. We will exclude studies where the participants were foster families. We will also exclude studies involving participants who started interventions more than one year after childbirth.
-
(I) Psychological and educational interventions that aim to prevent child abuse and neglect will be considered. Child abuse and neglect are defined and identified by the study authors. We will exclude interventions that aim to prevent specific risks but do not measure the effects of preventing child abuse and neglect (e.g., antenatal and postnatal depression, drug/alcohol use, HIV infection, smoking, intimate partner violence, family planning, and breastfeeding).
-
(C) Routine care, another type of intervention, placebo groups and waiting list groups, or no intervention will be included in the comparison group.
-
(O) Any index of child maltreatment (reports of child abuse, CPS case records, injury reports, hospital admission, and emergency room visits) will be included as a primary outcome. Additional outcomes will include measures of parenting stress (e.g., Parenting Stress Index, PSI [24]) and inappropriate parenting behavior (e.g., Conflict Tactics Scales, Parent-Child Version, CTS-PC [25]; Adult Adolescent Parenting Inventory-version 2, AAPI [26] (-2) [27]; Child Abuse Potential Inventory, CAPI [28]; CARE-Index [29]). If the included study has more than two parts, we will compare each intervention with the usual care.
-
(S) Peer-review articles written in English will be included. We will only include RCTs. The publication period will not be limited.
Study selection
In stage 1, two authors (HT and MS) will independently screen the titles and abstracts of all candidate studies and exclude those not applicable. Then, disagreements will be resolved by two authors, and a final list will be agreed upon. If agreement is not obtained, a third senior author (KT or YT) will arbitrate. If there is still disagreement, the article will go to the second stage. In stage 2, two authors (HT and MS) will independently evaluate for eligibility of the full-text versions of articles that have passed stage 1. Two authors (HT and MS) will resolve discrepancies by consensus, and if it is necessary, a third senior author (KT or YT) will perform the role of arbitrator.
Data extraction
HT and MS will independently pull the following related information from selected studies: author, year, publication language, location (country), intervention period (prenatal/postnatal/both), screening period for at-risk, type of risk, sample size (intervention and control), intervention program, setting (home or center), focus (support or packaged program), delivery (individual or group), occupation type of person delivering the intervention, duration of follow-up, frequency of sessions, comparison program, evaluation period, measurement tools, study results, and funding sources. The senior reviewers (KT and YT) will reconcile any disagreements.
Quality assessment and risk of bias
Two review authors (HT and MS) will independently check the risk of bias in each study that is included; a third review author (KT or YT) will resolve discrepancies by negotiation. We will use the revised Cochrane risk-of-bias tool for randomized trials to check the risk of bias in each study [25]. The tool includes the following domains: randomization process, deviations from the intended interventions, missing outcome data, measurement of the outcome, selection of the reported result, and overall risk of bias. The assessment process will involve extracting the appropriate information from each study (e.g., a detailed description of the method used for the randomization process) and evaluating the risk of bias in that area (e.g., adequate randomization process). We will determine risk of bias for each item as low, high, or of some concern while including a supporting description from the study report along with the reasoning for our judgment in a risk-of-bias table.
Statistical analysis
We plan to provide a narrative synthesis of the characteristics and findings from the included studies using text and tables. The synthesis will be based on intervention type and will describe the characteristics of each of the included studies and supply information about the effective measures for relevant outcomes and study quality.
A meta-analysis can be conducted depending on the availability of data and the degree of heterogeneity of each study. If there are studies with the same types of intervention and outcome measurement, we will conduct a random-effect meta-analysis and present a forest plot generated using the Review Manager 5.4. software.
Sub-group analyses will be considered based on the characteristics of the participants (e.g., age and socio-economic status, type of intervention (e.g., duration), timing of the intervention (during pregnancy and/or postpartum), and assessment points. A sensitivity analysis will be conducted to assess the effect of studies with a high risk of bias.
Reporting bias assessment
If there are 10 or more studies in the meta-analysis, we will examine reporting biases with funnel plots and visually consider any funnel plot asymmetry.
Certainty assessment
We will evaluate the quality of the evidence across studies by using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. Each result’s quality of evidence will be evaluated by using the study’s limitation, imprecision, indirectness, inconsistency, and publication bias [31].