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Table 1 List of procedures of biopsychosocial evaluation of the Pro Kind Follow-up

From: Follow-up study regarding the medium-term effectiveness of the home-visiting program “Pro Kind” at age 7 years: study protocol for a randomized controlled trial

Hypothesis Construct Operationalization Primary or secondary outcome domains Informant Data source
Hypothesis 1.1: The home-visiting program has a positive effect on the child’s cognitive development and school performance Child’s school performance Basic diagnostics of specific developmental disorders of speech and language at primary school age (BUEGA [55]) Primary outcome domain Child Testing by trained test administrator
Child’s cognitive development
Child’s specific developmental disorders
Hypothesis 1.2: The home visits have a positive effect on the child’s mental health Child’s behavioral problems and emotional disorders Child Behavior Checklist (CBCL 6/18 R [60]), German version: [61] Primary outcome domain Mother Questionnaire
Child’s attention deficit hyperactivity disorder and social behavior disorders (suspected diagnosis) Module from the diagnostic interview of mental disorders in children and youths (Kinder-DIPS [52]) Mother Interview by trained and certified staff
Child’s anxiety disorders (suspected diagnosis)
Child’s affective disorders (suspected diagnosis)
Hypothesis 1.3: The home visits have a positive effect on the child’s socio-emotional development Child’s social skills Social Skills Improvement System (SSIS [62]), German version: author’s translation Secondary outcome domain Mother Questionnaire
Child’s aggression Questionnaire regarding children’s aggressive behavior (FAVK [63]) Mother Questionnaire
Child’s psychopathy Inventory of Callous-Unemotional Traits (ICU) ([64]), German version by Essau Mother Questionnaire
Hypothesis 1.4: The home visits have a positive effect on the child’s life satisfaction. Child’s general life satisfaction Inventory to measure the life quality of children and youths (ILK [65]) Primary outcome domain Child Survey by trained test administrator
Hypothesis 1.5: The home visits influence the child’s preferences (risk behavior, pro-social behavior and time preference). Child’s pro-social behavior Game for interpersonal allocation decisions ([57]). Secondary outcome domain Child Testing by trained test administrator
Child’s risk behavior Investment decisions in a lottery ([56])
Child’s time preference Game for temporary allocation decisions ([58])
Hypothesis 2.1: The home visits result in improved parenting skills (less inappropriate parenting behavior) Mother’s dysfunctional parenting Parenting Scale (PS) ([66]), German version: target-group-specific adaptation by the authors Primary outcome domain Mother Questionnaire
Mother’s non-violent disciplining Conflict Tactic Scale Child Report (CTS-CR [68]), interview of the children with picture cards. German version: translation by the AMIS group / Conflict Tactic Scale Parent Child (CTS-PC [67]), German version: target-group-specific adaptation by the authors Child / Mother Interview through trained test administrator (Child) / Questionnaire (Mother)]
Hypothesis 2.2: The home visits reduce or prevent child abuse and the frequency of physical violence Mother’s child abuse Conflict Tactic Scale Parent Child (CTS-PC) ([54]), German version: target-group-specific adaptation by the authors Primary outcome domain Mother Questionnaire
Mother’s “Minor” aggression Conflict Tactic Scale Child Report (CTS-CR [68]), interview of the children with picture cards. German version: translation by the AMIS group / Conflict Tactic Scale Parent Child (CTS-PC) ([54]), German version: target-group-specific adaptation by the authors Child / mother Interview through trained test administrator (Child) / Questionnaire (Mother)
Mother’s “Minor” physical violence
Hypothesis 2.3: The home visits reduce or prevent child neglect Mother’s physical neglect Scale of the Multidimensional Neglectful Behavior Scale-Child Report (MNBS [53]), interview of the children with picture cards. German version: translation by the AMIS group. Primary outcome domain Mother Questionnaire
Mother’s emotional neglect Child / mother Interview through trained test administrator (Child) / Questionnaire (Mother)
Mother’s cognitive neglect
Mother’s supervisory neglect
Hypothesis 3.1: The home visits have a positive effect on the mother’s perceived social support Mother’s Perceived social support Questionnaire regarding social support (FSOZU-K6 [71]) Secondary outcome domain Mother Questionnaire
Hypothesis 3.2: The home visits influence the mother’s mental health Mother’s mental stress Depression-Anxiety-Stress Scale (DASS [70]), German version: target-group-specific adaptation by the authors Primary outcome domain Mother Questionnaire
Hypothesis 3.3: The home visits result in more stable partnerships with less frequent partner change, greater satisfaction with the partnership and less domestic violence in the partnership Mother’s stability of partnership Developed by the authors Secondary outcome domain Mother Questionnaire
Mother’s partnership satisfaction Short form of the Partnership Questionnaire (PFB-K [74])
Psychological aggression against mother Conflict Tactics Scales (CTS2 [54]; German version: target-group-specific adaptation by the authors [forward-backward]
Physical violence against mother
Sexual assault against mother
Injuries due to assaults by the partner
Hypothesis 3.4: The home visits improve the parental self-efficacy expectations regarding the parenting tasks Mother’s parenting self-efficacy Parenting Sense of Competence Scale (PSOC) ([76]), German version: target-group-specific adaptation by the authors Secondary outcome domain Mother Questionnaire
Hypothesis 3.5: The home visits have a positive effect on the perceived stress resulting from the mother’s parenting tasks Mother’s parenting stress Parenting Stress Index (PSI [72]), German version: Eltern-Belastungs-Inventar (EBI [73]). Secondary outcome domain Mother Questionnaire
Hypothesis 3.6:The home visits have a positive effect on the mother‘s life satisfaction Mother’s general life satisfaction Questions regarding life satisfaction (FLZ [77]) Primary outcome domain Mother Questionnaire
Hypothesis 4.1: The home visits increase the share of mothers in employment or education programs Mother’s acceptance of employment The German Socio-Economic Panel (SOEP) [49] and Secondary outcome domain Mother Questionnaire
Mother’s acceptance of training or educational offers The Panel Arbeitsmarkt und Soziale Sicherung ([78]) Mother Questionnaire
Hypothesis 4.2: The home visits reduce the families’ use of welfare payments (SGB II, SGB III and SGB VIII [social security codes]). Welfare payments Integrated employment history provided by the Institute of Employment Research (IAB) Secondary outcome domain Institute of Employment Research (IAB) Administrative data
Hypothesis 4.3: The home visits have a positive effect on the family’s living situation Family situation The Home Observation for Measurement of the Environment (HOME [59] forward-backward translation by the authors) Secondary outcome domain Staff Observation
Hypothesis 4.4: The home visits influence the timing or frequency of a renewed pregnancy and births Renewed pregnancy Questionnaire about intended and realized fertility (Siedler et al., 2009).
Integrated Employment History provided by the Institute of Employment Research (IAB)
Secondary outcome domain Mother/ Institute of Employment Research (IAB) Questionnaire/ administrative data
Renewed desire to have children
Abortions Births
Hypothesis 5.1: The home visits improve the mothers’ physical health Mother’s physical health 12-Item Short Form Survey (SF-12 [79]) Secondary outcome domain Mother Questionnaire
Hypothesis 5.2: The home visits increase the frequency of pediatric primary care use (e.g., screenings, vaccinations, child’s oral health care and dentist visits) Frequency of pediatric primary care use KiGGS questionnaire [80]
physician visits with ICD Z
Secondary outcome domain Mother health insurance companies Questionnaire/administrative data
Hypothesis 5.3: Home visits reduce the children’s hospital visits (outpatient or inpatient) caused by accidents and injuries Number of child’s injuries Hospital admission and physician visits with ICD S and T Secondary outcome domain Health insurance companies Administrative data