In this RCT the following hypotheses will be tested:1. The Prenatal Video Feedback Intervention to promote Positive Parenting (VIPP-PRE) results in different hormonal, neural, and behavioral responses to infant stimuli and video clips designed to…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
study does not concern any medical condition, but studies the effect of a behavioral intervention on fatherhood
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
We propose to conduct a randomized controlled trial (RCT) with a
between-subject design in a critical phase of parenthood: the transition to
having the first baby. We focus on the 50% of parents who have been neglected
in parenting research and *until recently- in family policies: fathers. In most
western countries fathers have increased their participation in parenting over
the past decades. And even though in most families the participation of fathers
in child rearing is modest, the parental role of fathers is highly relevant for
child development (e.g., Kok et al., 2015; Ramnchandani et al., 2005). We will
test the effects of a prenatal version of the Video Feedback Intervention to
promote Positive Parenting (VIPP, Juffer et al., 2008) on fathers* hormonal
levels, on their processing of infant signals, and on their parenting behavior,
including the quantity (involvement) and quality (sensitivity) of father-child
interaction. The proposed study tests whether exposure to and interaction with
the unborn infant increase the father*s involvement during pregnancy and after
birth. A special focus is on a dimension of parenting that has received
considerable attention in animal research but, despite its evolutionary
importance, not in studies on humans: the role of the parent as protector.
Study objective
In this RCT the following hypotheses will be tested:
1. The Prenatal Video Feedback Intervention to promote Positive Parenting
(VIPP-PRE) results in different hormonal, neural, and behavioral responses to
infant stimuli and video clips designed to elicit protective parenting
2. VIPP-PRE promotes fathers* parenting in terms of quantity (involvement) and
quality (sensitive interaction)
3. VIPP-PRE affects fathers* basal hormonal levels (i.e. oxytocin, vasopressin,
cortisol, estradiol, and testosterone), which in turn may mediate neural and
behavioral effects.
Secondary objective
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.
Study design
The RCT includes an experimental group and a control group, and will be
conducted during pregnancy (i.e. gestational age 20-30 weeks). The
interventions start 1-2 weeks after the pretest. The first posttest is
administered 1-2 weeks after the intervention, and a follow-up 5-6 months later
(i.e. infant is 8 weeks old).
Intervention
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 and last for
approximately one hour. Fathers will be invited to interact with the fetus both
verbally and by touching and softly massaging the infant through the mother*s
abdominal wall. The baby*s behavior will be made visible through ultrasound.
Study burden and risks
There are no risks associated with the assessments used in this study. No
adverse effects have been reported in participants/patients undergoing MRI at
the currently available field strengths. The burden associated with
participation (producing ten saliva samples, three visits to the LUMC, three
intervention sessions, online and app questions) has been approved by the
Toetsingscommisie Ethiek Pedagogische Wetenschappen (see ECPW2017-170). The use
of non-medical prenatal ultrasound in this study is strictly regulated and
considered safe.
Once we understand the neurobiological underpinnings of good-enough and
poor parental sensitivity and protection, better attempts can be made to
improve parenting and reduce the adverse effects of poor parenting. Thus, the
importance of the benefits gained from this research outweighs the minimal
risks involved.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
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
* 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
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL62696.058.17 |