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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