The primary objective is to assess the effect of the parenting support intervention on parental stress. Secondary objectives are the effect of theintervention on other parental outcomes (anxiety and depression, satisfaction with the parental role,…
ID
Source
Brief title
Condition
- Family issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study will be parenting stress.
Secondary outcome
Secondary outcomes will be parent's well-being (indicated by anxiety and
depression, satisfaction with the parenting role and self-efficacy in
caring for the infant); caregiving (attachment, breastfeeding duration, and
co-sleeping); and the infant's well-being (sleeping, crying and feeding
problems and health).
Background summary
The first months after birth can be challenging for parents and affect
well-being. This might lead to high parental stress and to other negative
outcomes for the parents (e.g. to postpartum depressive symptoms). Parents with
high levels of parental stress are also less able to respond
adequately and sensitively to their infant. This might lead to less secure
attachment bonds and to less than optimal infant (brain) development.
Effective interventions to reduce parental stress are available but until now
only used for high-risk groups. Furthermore, those interventions
focus exclusively on the mother. The proposed study focuses on a parenting
support intervention consisting of psycho-education and practical
tools. This intervention is aimed at reducing parental stress for both parents.
Study objective
The primary objective is to assess the effect of the parenting support
intervention on parental stress. Secondary objectives are the effect of the
intervention on other parental outcomes (anxiety and depression, satisfaction
with the parental role, self-efficacy in caring for their infant),
caregiving outcomes (bonding, duration of breastfeeding and co-sleeping) and on
infant well-being (indicated by their patterns of crying and
sleeping behaviour and the infant*s health).
Study design
The proposed study is a randomized controlled intervention study. Random
allocation will take place at the individual level on a 1:1 ratio to either
the intervention or a wait-list control group. Participants are randomized
using random sequence block randomization (blocks of 2, 4 or 6),
stratified by birth order of their child (first or second) and participation of
the father (participate/not participate). Patients will receive the outcome
of randomization by mail. Due to the nature and design of the study, blinding
of the researchers or participants is not possible.
Intervention
The parenting support intervention is based on the work of Hiscock et al (2014)
about infant sleeping and crying patterns which has proven to
be effective on parents* and infants* health. We add information about how to
respond to signals of distress which is essential for the bonding
process. The intervention will be introduced prenatally, between the 34th and
the 36th week of pregnancy. Parents will receive a booklet and
access to an online video which will be accessible with individual credentials.
During a subsequent prenatal home visit, parents will receive
further explanation about the materials and how to implement the tools
provided. Also, they are given the opportunity to ask questions. Parents
will receive a phone call 4 weeks after birth, to ask how they are doing and to
further support them with implementing the intervention.
Study burden and risks
Participation in the proposed study contributes to a better understanding of
how parents can be supported prenatally in preparing for parenthood
and the first months with a newborn infant. The main burden for parents will be
to keep the infant behavior diary, and to fill in the questionnaires
pre- and postnatally. In the experimental group, parents also need to read the
booklet and watch the online video before the child is born.
Van der Boechorststraat 1
Amsterdam 1081 BT
NL
Van der Boechorststraat 1
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
* Women expecting their first or second child
* Uncomplicated pregnancy
* Sufficient Dutch language proficiency (to understand the information in the booklet and on the website)
* Access to a computer and the internet
Exclusion criteria
* Current psychopathology (defined as current treatment for psychopathology or treatment in the 6 months before inclusion)
* Insufficient Dutch language proficiency
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL58528.028.16 |
OMON | NL-OMON24862 |