Follow-up Assessment of the Midterm Efficacy of the Home Visiting Program Pro Kind Based on a Randomized Controlled Trial

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00007554
• Date of registration: 11/06/2015
• Prospective Registration: Yes
• Primary sponsor: Kriminologisches Forschungsinstitut Hannover
• Public title: Follow-up Assessment of the Midterm Efficacy of the Home Visiting Program Pro Kind Based on a Randomized Controlled Trial
• Scientific title: Follow-up Assessment of the Midterm Efficacy of the Home Visiting Program Pro Kind Based on a Randomized Controlled Trial
• Date of first enrolment: 15/06/2015
• Target sample size: 755
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00007554
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: prevention

Countries of recruitment

Germany

Contacts

• Name: Sabrina Lauenroth
• Affiliation: Kriminologisches Forschungsinstitut Hannover

• Name: Sören Kliem
• Affiliation: Kriminologisches Forschungsinstitut Hannover

Key inclusion & exclusion criteria

Inclusion criteria: Participation in the first stage of the Pro Kind evaluation. Resident in Germany. (In the first program stage Pro Kind intervention registered only financially or socially disadvantaged first-time mothers during their 12th to 28th weeks of pregnancy. Financial disadvantage is defined as receipt of social welfare benefits, unemployment compensation, an income that is as low as social welfare benefits, and/or over-indebtedness. The considered social risk factors included, for example, low education, teenage pregnancy, social isolation, violent experiences, and health problems.)
Exclusion criteria: Insufficient knowledge of German language, without permanent residence permission.

Age minimum: None
Age maximum: None
Gender: Female

Health Condition(s) or Problem(s) studied

Mental stress and disruptions, family health, parental efficacy, school and social competencies of the children, cognitive and socio-emotional child development, aggression of the child, child abuse and neglect, physical aggression and violence against the child, Bullying and victimization of the child.

Intervention(s)

Group 1: The follow-up evaluation does not contain any intervention. In the age of 6 to 7 one combined interview with the mother and a developmental test with the child are conducted. Additionally, one telephone interview takes place, the child's teacher is interviewed and administrative data from the Federal Employment Agency and from health insurance companies are requested.

In the first Pro Kind project stage, arm 1 had access to the regular German welfare state services. They received monetary incentives for participating in the study, feedback on child development and an address list with support services. Additionally women in the treatment group received the Pro Kind home visits.
Group 2: Arm 2 does not receive any intervention in the follow-up evaluation. In the age of 6 to 7 one combined interview with the mother and a developmental test with the child are conducted. Additionally, one telephone interview takes place, the child's teacher is interviewed and administrative data from the Federal Employment Agency and from health insurance companies are requested.

In the first project stage arm 2 had access to the regular German welfare state services. They received monetary incentives for participating in the study, feedback on child development and an address list with support services.

Primary Outcome(s)

In the age of 6 to 7 one combined interview with the mother and a developmental test with the child are conducted. Additionally, one telephone interview takes place, the child's teacher is interviewed and administrative data from the Federal Employment Agency and from health insurance companies are requested.
The home visiting program has a positive effect on the child’s cognitive development and school performance.
-->School performance: Basic diagnostics of Specific Developmental Disorders of Speech and Language at primary school age (BUEGA)
-->Cognitive development: BUEGA
-->Specific developmental disorders: BUEGA
The home visits have a positive effect on the child’s mental health.
-->The child’s behavioral problems and emotional disorders: Child Behavior Checklist (CBCL 6/18 R]), German version
The home visits have a positive effect on the child’s life satisfaction.
-->General Satisfaction with life: Inventory scale to measure the life quality of children and youths (ILK)
The home visits result in improved parenting skills (less inappropriate parenting behavior)
-->Dysfunctional parenting: Parenting Scale (PS), German version: target-group-specific adaptation by the authors
-->Non-violent disciplining: Conflict Tactic Scale Child Report (CTS-CR), interview of the children with picture cards. German version: translation by the AMIS group / Conflict Tactic Scale Parent Child (CTS-PC), German version: target-group-specific adaptation by the authors
The home visits reduce or prevent child abuse and the frequency of physical violence.
-->“Minor” aggression: CTS-CR and CTS-PC
-->“Minor” physical violence: CTS-CR and CTS-PC
-->Child abuse: CTS-PC
The home visits reduce or prevent child Neglect.
->Physical neglect: Scale of the Multidimensional Neglectful Behavior Scale-Child Report (MNBS), interview of the children with picture cards. German version: translation by the AMIS group.
-->Emotional neglect: MNBS
-->Cognitive neglect: MNBS
-->Supervisory neglect: MNBS
The home visits influence the mother’s mental health
-->Mental stress:Depression-Anxiety-Stress Scale (DASS), German version: target-group-specific adaptation by the authors
The home visits have a positive effect on the mother‘s life satisfaction.
-->General life satisfaction: Questions regarding life satisfaction (FLZ)

Secondary Outcome(s)

The home visits have a positive effect on the child’s mental health.
-->Attention deficit hyperactivity disorder and social behavior disorders (suspected diagnosis): Module from the diagnostic interview of mental disorders in children and youths (Kinder-DIPS)
-->Anxiety disorders (suspected diagnosis): Kinder-DIPS
-->Affective disorders (suspected diagnosis): Kinder-DIPS
The home visits have a positive effect on the child’s socio-emotional development.
-->The child’s social skills: Social Skills Improvement System (SSIS), German version: author’s translation
-->Aggression: Questionnaire regarding children’s aggressive behavior (FAVK)
-->Psychopathy: Inventory of Callous-Unemotional Traits (ICU), German version by Essau
The home visits influence the child’s preferences (risk behavior, pro-social behavior and time preference).
-->Pro-social behavior: Game for interpersonal allocation decisions
-->Risk behavior: Investment decisions in a lottery
-->Time preference: Game for temporary allocation decisions
The home visits have a positive effect on the mother’s perceived social support.
-->Perceived social support:Questionnaire regarding social support (FSOZU-K6)
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
-->Stability of partnership: Developed by the authors
-->Partnership satisfaction: Short form of the Partnership Questionnaire (PFB-K ) Psychological aggression: Conflict Tactics Scales (CTS2); German version: target-group-specific adaptation by the authors [forward-backward]
-->Psychological aggression: CTS2
-->Physical violence: CTS2
-->Sexual assault:CTS2
-->Injuries due to assaults by the partner: CTS2
The home visits improve the parental self-efficacy expectations regarding the parenting tasks.
-->Parenting self-efficacy: Parenting Sense of Competence Scale (PSOC)), German version: target-group-specific adaptation by the authors
The home visits have a positive effect on the perceived stress resulting from the mother’s parenting tasks.
-->Stress, parenting: Parenting Stress Index (PSI ), German version: Eltern-Belastungs-Inventar (EBI )
The home visits increase the share of mothers in employment or education programs.
-->Acceptance of employment and Acceptance of training or educational offerings: The German Socio-Economic Panel (SOEP) and the Panel Arbeitsmarkt und Soziale Sicherung
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)
-->The home visits have a positive effect on the family’s living situation.
-->Family Situation: The Home Observation for Measurement of the Environment (HOME forward-backward translation by the authors)
The home visits influence the timing or frequency of a renewed pregnancy and births
-->Renewed pregnancy / Renewed desire to have children / Abortions / Births: Questionnaire about intended and realized fertility. Integrated Employment History provided by the Institute of Employment Research (IAB)
The home visits improve the mothers’ physical health.
-->Mother’s physical health: 12-Item Short Form Survey (SF-12)
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 and doctor visits with ICD Z
Home visits reduce the children’s hospital visits (outpatient or inpatient) caused by accidents and injuries.
-->Number of injuries: Hospital admission and doctor visits with ICD S and T

Source(s) of Monetary Support

Bundesministerium für Bildung und Forschung Dienstsitz Bonn

Ethics review

Status: Approved
Approval date: 29/05/2015
Contact:

[e-mail]

Ethikkommission der DGPs (Deutsche Gesellschaft für Psychologie) [Ethik-Kommission DGPsychologie]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00007554#studyResults