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Evaluation of the home visiting program "Pro Kind" for disadvantaged first time mothers
Last registered on March 30, 2017

Pre-Trial

Trial Information
General Information
Title
Evaluation of the home visiting program "Pro Kind" for disadvantaged first time mothers
RCT ID
AEARCTR-0002135
Initial registration date
March 30, 2017
Last updated
March 30, 2017 3:21 PM EDT
Location(s)

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Primary Investigator
Affiliation
University Collége London
Other Primary Investigator(s)
PI Affiliation
Criminological Research Institute of Lower Saxony
Additional Trial Information
Status
On going
Start date
2007-01-01
End date
2050-01-01
Secondary IDs
Abstract
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.
External Link(s)
Registration Citation
Citation
Kliem, Sören and Malte Sandner. 2017. "Evaluation of the home visiting program "Pro Kind" for disadvantaged first time mothers." AEA RCT Registry. March 30. https://doi.org/10.1257/rct.2135-1.0.
Former Citation
Kliem, Sören, Malte Sandner and Malte Sandner. 2017. "Evaluation of the home visiting program "Pro Kind" for disadvantaged first time mothers." AEA RCT Registry. March 30. http://www.socialscienceregistry.org/trials/2135/history/15608.
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Experimental Details
Interventions
Intervention(s)
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
2007-01-01
Intervention End Date
2012-12-31
Primary Outcomes
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
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
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
Not available
Randomization Method
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.
Randomization Unit
Individual (expectant mother)
Was the treatment clustered?
No
Experiment Characteristics
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.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Ethik-Kommission DGPsychologie
IRB Approval Date
2015-01-25
IRB Approval Number
SK 122014