study does not concern any medical condition, but studies the effect of a behavioral intervention on fatherhood n.a.
Conditions
Interventions
The VIPP-PRE consists of three sessions between the 21th and 30th week of
pregnancy. Parents are seen by an intervener and a prenatal ultrasound
professional. The sessions take place every 1-2 weeks
Sponsors
Universiteit Leiden
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Fathers having their first baby. * The parents must have had the 20-week medical ultrasound via regular health care services. * Partners of the fathers must be low-risk expecting women with uncomplicated singleton pregnancies between the 21th and 30th week of gestation.
Exclusion criteria
Exclusion criteria: * Not living in the same house as their partner * Not fluent in Dutch * Endocrine disorders * Alcohol and drug abuse * Use of medication potentially interfering with the endocrine system * MRI contraindications, including metallic foreign objects, neurological disorder and claustrophobia * Psychiatric disorder * Cardiovascular disease * Birth defects in the families of either the father or the mother. * Further, fathers with partners who meet any of the following criteria will be excluded: alcohol, tobacco or illicit drug use during pregnancy, BMI over 30 before pregnancy, or abnormalities found during the regular 20-week ultrasound. ;Parents who absolutely do not want to know the gender of their unborn baby are advised to carefully consider participation, since this might unintentionally be visible during ultrasound.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are: * Parenting behavior, including physiological response to infant stimuli (*handgrip task*), sensitivity (*quality of care*), involvement (*quantity of care*), and protection (*Auditory Startling Task*). We will examine the effects of VIPP-PRE on these parenting behaviors. * Activity in brain areas associated with parenting. We will examine the effects of VIPP-PRE on activity in these areas in fathers during the processing of infant signals and brief video vignettes designed to elicit protective parenting. * Oxytocin, vasopressin, and estradiol levels will be assessed in saliva. Cortisol and testosterone will be assessed in both saliva and hair samples. Saliva samples are used to measure current hormonal levels. Hair samples provide information on hormone levels in past period: as human scalp hair grows approximately 1 cm per month, hormone concentrations in 1 cm hair reflect the mean exposure of 1 month. These assessments have all previously been approved by the METC and the CCMO (see NL54702.058.15 and nr. NL49069.000.14) and tested in a pilot sample (see NL54702.058.15 and P15.359). These measures take place at the LUMC. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will examine the extent to which effects of the VIPP-PRE intervention are moderated by fathers* early childhood experiences. Although fathers* early childhood experiences are known to moderate the effects of nasally administered oxytocin, it is not yet clear whether this also holds for endogenously produced oxytocin. | — |
Countries
Netherlands
Outcome results
None listed