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ImportanceHome-based interventions targeting socially disadvantaged families may help to improve maternal and child health. Only a few studies have investigated how different staffing models affect early home visiting program outcomes.ObjectiveTo assess the effects of 2 staffing models of an early childhood intervention on mother and child outcomes.Design, Setting, and ParticipantsThe baseline assessment of this randomized trial was conducted between November 2006 and December 2009 in 15 municipalities in Germany. The follow-up assessment at offspring age 7 years was carried out by interviewers masked to treatment conditions from April 2015 to December 2017. Data analysis was performed from March to August 2023. Pregnant women with no previous live birth, low-income, and at least 1 additional psychosocial risk factor were eligible. A total of 1157 women were referred to the study by gynecologists, psychosocial counseling services, or employment agencies; 755 were randomized to treatment conditions (2 intervention groups and 2 control groups); and 525 completed the follow-up.InterventionsBased on the Nurse-Family Partnership program, women assigned to the intervention groups received visits by either a midwife (midwife-only model) or by a team consisting of a social worker and a midwife (tandem model) until child age 2 years. Women assigned to control groups had access to the standard health and social services.Main Outcomes and MeasuresAverage treatment effects (ATEs) on the following primary outcomes were assessed using adjusted regression models with inverse probability weighting: developmental disorders, child behavioral problems, adverse, neglectful and abusive parenting, maternal mental health, and life satisfaction.ResultsThe mean (SD) age at follow-up was 29.6 (4.36) years for mothers and 7.55 (0.75) years for children; 272 (52.2%) of the children were female. Mothers in the tandem model reported fewer internalizing child behavioral problems compared to their control group (ATE, 2.98; 95% CI, −5.49 to −0.47; absolute reduction, 13.3 percentage points). Beneficial intervention effects were found in the midwife-only group on abusive parenting (ATE, −4.00; 95% CI, −6.82 to −1.18), parenting stress (ATE, −0.13; 95% CI, −0.20 to −0.06), and maternal mental health burden (ATE, −3.63; 95% CI, −6.03 to −1.22; absolute reduction, 6.6 percentage points in depressive symptoms), but not in the tandem group.Conclusions and RelevanceBoth staffing models produced positive intervention effects, with more effects seen in the midwife-only model. These insights can guide future early childhood intervention designs and may help improve health care for socially disadvantaged families.Trial RegistrationGerman Clinical Trials Register Identifier: DRKS00007554
BackgroundRigorous research trials have demonstrated that early childhood interventions can reach socially disadvantaged families and can have a lasting impact on the healthy development of their children. However, little is known about the internal and contextual factors that contribute to the long-term implementation of such interventions. In this study, we investigated the development of the home visiting program Pro Kind. The program was adapted from the evidence-based US-American Nurse-Family Partnership program and was implemented in Germany in 2006. Using an exploratory approach, we examined factors contributing to the long-term implementation of this program.MethodsQualitative interviews with program implementers (midwives, social workers, program managers) of the Pro Kind program and key stakeholders in two cities in Germany were conducted. Interview guides were developed to assess participants' perceptions and experiences on how the program had developed over time internally and in the interaction with its environment. Data were collected between March and September 2021. Drawing on the Consolidated Framework for Implementation Research (CFIR), data was coded according to the principles of thematic analysis.ResultsA total of 25 individuals (11 program implementers, 14 key stakeholders) were interviewed. The identified factors related to three out of five domains of the CFIR model in our analysis. First, regarding the intervention characteristics, the evidence of effectiveness and the relative advantage of the implementation of the program compared to similar interventions were viewed as contributors to long-term implementation. However, the program's adaptability was discussed as a constraining factor for reaching the target group. Second, concerning the inner setting, stakeholders and program implementers perceived the implementation climate, the leadership engagement and the program's size as relevant factors for networking strategies and program visibility. Third, as part of the outer setting, the degree of networking with external stakeholders was highlighted of great importance for the program.ConclusionsWe identified several factors of particular importance for the long-term implementation and sustainability of an early childhood intervention at the practice level, particularly in the local context in Germany. These findings should inform the design of impactful, scalable, and sustainable early childhood interventions targeting disadvantaged families.
BackgroundThe Nurse-Family Partnership (NFP) is an evidence-based home visiting program shown to improve maternal and child outcomes. Pro Kind is the first German adaptation of NFP, implemented between 2006 and 2012. While earlier evaluations demonstrated short- and medium-term benefits, no European trial has yet assessed long-term effects into adolescence. ObjectivesThis study protocol outlines the third phase of the Pro Kind randomized controlled trial (RCT), designed to evaluate the program’s effectiveness 14–16 years post-intervention. Primary aims are to assess adolescent and maternal outcomes related to mental health, parenting, risk behaviors, and life satisfaction, as well as potential long-term economic effects.MethodsThe original RCT enrolled 755 pregnant women with psychosocial risk factors, randomly assigned to an intervention (n = 394) or control group (n = 361). The intervention comprised structured home visits from midwives or tandem teams (midwife + social worker) from pregnancy until the child’s second birthday. The 15-year follow-up combines self-report data (via online interviews and questionnaires) and administrative records on employment, social benefits, and criminal justice involvement. Discussion: This study represents the first long-term follow-up of an NFP adaptation in Europe. While U.S. trials of NFP provide evidence of the program’s effectiveness, these results cannot be generalized to European welfare contexts. This underscores the need for long-term evaluations of NFP adaptations in Europe to generate evidence that can inform policy and ensure evidence-based decision making.