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Evaluation of the home visiting program "Pro Kind" for disadvantaged first time mothers
Initial registration date
March 30, 2017
March 30, 2017 3:21 PM EDT
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University Collége London
Other Primary Investigator(s)
Criminological Research Institute of Lower Saxony
Additional Trial Information
Pro Kind is a home visiting program to support disadvantaged families. It was implemented in three German states (Bremen, Lower Saxony and Saxony) with a sample of 755 first-time, welfare receiving, at-risk, expectant mothers from 2006 to 2010. Half of the participants were randomly allocated to the home visits which began between the 12th and 28th weeks of pregnancy and ended at the child’s second birthday. The frequency of the home visits varied between weekly, biweekly, and monthly visits, with the highest visit frequency occurring directly before and after birth. Overall, 52 home visits with an average duration of 90 minutes are scheduled between pregnancy and the child’s second birthday. An interdisciplinary research team evaluates the short-, mid-, and longterm effects of the program on family environment, maternal and child health, and child development. Data is collected by face to face and telephone interviews, and objective child developmental assessments, such as the Bayley Scales of Infant Development . Additionally, parts of the participants were merged with administrative social security records and health insurance utilization data. Assessments and interviews were conducted during pregnancy, at 6, 12 and 24 months after births. At the moment data is collected at children's age 6 to 7.
Kliem, Sören and Malte Sandner. 2017. "Evaluation of the home visiting program "Pro Kind" for disadvantaged first time mothers." AEA RCT Registry. March 30.
The intervention includes home visits for disadvantaged first time mothers from pregnancy until the second birthday of the child. The home visits were conducted by trained midfives or social pedagogues. Teaching materials and visit-by-visit guidelines structured the theme and aim of each home visit. Nevertheless, home visitors had the flexibility to adapt the contents to maternal needs and the familial situation. All home visitors regularly received feedback, encouragement, reflection, and support from nurse supervisors. Implementation data shows that the Pro Kind intervention was well implemented. Families who participated in the program until the child’s second birthday received on average 45.3 home visits (SD = 10.7, range: 11-94).
Intervention Start Date
Intervention End Date
Primary Outcomes (end points)
Child mental and cognitive development, child school readiness, maternal and child health, maternal life course development, child preference formation
Primary Outcomes (explanation)
The outcomes will be obtained by direct assessment, experimental games, surveys or administrative data. Maternal life course development includes fertility, labour market participation and welfare dependency. Dates of assessment were pregnancy, 6, 12 and 24 months after birth. At the recent follow up assessment children will be between 6 and 7 years old.
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Half of the mothers were randomly allocated to a control and a treatment group. Allocation happened after affiliation criteria were checked and informed consent was signed by the participants. Only participants who were allocated to the treatment group received full information about the intervention. The control group just received information regarding the research.
Experimental Design Details
The randomization was done in office by a computer. The program used a Efron biased coin design. The result of the randomization was given to the interviewer of the baseline interview in a closed envelope. Only after affiliation criteria were checked and informed consent was signed by the participants the envelope was opened.
Individual (expectant mother)
Was the treatment clustered?
Sample size: planned number of clusters
755 expactant mothers
Sample size: planned number of observations
755 expactant mothers
Sample size (or number of clusters) by treatment arms
394 expactant mothers treatment group, 361 expactant mothers control group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
This study has 80.0% power to detect effect sizes of 0.2 SD.
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Approval Date
IRB Approval Number