Depression Clinical Trial
Official title:
NewPreBP: Project Newborn -Preparation for Birth and Parenthood. A Large Interdisciplinary Randomised Trial on the Effect of Birth and Parent Preparation
The Danish regions aim to implement antenatal education in small groups for all expectant
parents. The effects of general antenatal education for childbirth or parenthood, or both,
remain largely unknown. Also it is unknown if antenatal education in small groups is superior
to antenatal lectures which is currently standard care.
The aim of the trial is to evaluate if antenatal birth and parent preparation in small groups
can increase parenting resources thereby easing birth and creating a smoother and less
stressful transition to parenthood among the participants, compared to those allocated to
standard care. This in turn is hypothesized to improve health and thriving among newborn
families and affect their use of healthcare services. A thorough process evaluation will be
conducted highlighting enabling factors and barriers to the implementation. Finally
cost-effectiveness analysis will be conducted.
Individually randomised trial sited at Hvidovre Hospital, a large birth clinic in the
Copenhagen Capital Region of Denmark.
Participants: 1756 pregnant women ≥ 18 years old, recruited before 20+0 weeks gestation, due
to give birth at Hvidovre Hospital. Being legally able and willing to provide signed consent,
and being fluent in Danish.
Women are randomised to receive:
1. A research-based birth and parenting program. The intervention consists of 4 sessions in
small groups that last for 2,5 hours per session at 25, 33 and 35 weeks of gestation,
and a post-natal session 5 weeks after expected due date.
2. Standard care (control group). The pregnant woman and her partner are offered two
antenatal lectures in an auditorium.
The allocation of participants to the intervention will be 1:1 to the intervention and the
control group.
Data will be collected via questionnaires at baseline, 37 weeks gestation, 9 weeks
post-partum, 6 months post-partum and 1 year post-partum, via the hospital obstetric
database, and via the national registers. Analyses will be intention to treat. Subgroup
analysis will be conducted in relation to personal and demographic characteristics. Process
evaluation will be conducted using questionnaires and qualitative interviews. The incremental
societal cost of the intervention will be computed and compared to the measured outcomes in a
cost-effectiveness analysis.
Outcomes: Stress, parenting alliance, depressive symptoms, wellbeing obstetric intervention,
use of health care services, self-efficacy, divorce.
Antenatal education Today Danish antenatal classes are primarily offered in auditoriums as
lectures with a minimum of interaction with the audience. The Danish regions currently aim in
time to implement antenatal birth and parent preparation classes in small groups for all
expectant parents. However, it is unknown if 1) antenatal preparation in small groups is
superior to standard care; 2) what elements the preparation should encompass to meet the
needs of expectant parents today; and 3) what the cost-effectiveness of antenatal preparation
in small groups is compared to large-scale preparation in auditoriums.
Trial objectives and purpose The primary aim is to compare parenting resources, health and
thriving, and use of healthcare services in newborn families enrolled in a research-based
standardised antenatal birth and parenting program in small groups with those allocated to
standard care.
Development of the program: We have developed a comprehensive, theoretically founded
parenting program in collaboration with midwives, health care visitors, a psychologist and
family therapist, parents, and leading national and international researchers and clinicians
in this field.
Process evaluation: Focus group interviews with service providers, group facilitators and
participants will be carried out. Program fidelity e.g. whether the protocol is followed in
program delivery, and how much of the intended program the participants are receiving, as
well as program reach e.g. what proportions of the intended groups are participating in the
program, has an impact on the effect of an intervention. We will evaluate whether the
protocol is followed in program delivery and how much of the intended program the
participants are receiving. Participants will be asked to fill in an electronic questionnaire
on-site at the end of each session. The questionnaire will highlight whether the intended
subjects of the session have been covered as well as to what extent the participants found
the information given useful. Group facilitators will be asked to fill in a similar
questionnaire with the opportunity to explain why certain topics may have been omitted.
Non respondent/non-participation: What proportions of the intended groups are participating
in the program will be explored by examining demographic characteristics of those who
declined to participate in the trial via the national registers, as well as examining
characteristics of those who accepted and then did or did not show up for the sessions.
Cost-effectiveness analysis: Finally the incremental societal cost of the intervention will
be calculated and compared to the measured outcomes in a cost-effectiveness analysis. Direct
health care costs as well as productivity costs in terms of labour market participation and
sickness absence. For this we will use data from the obstetric database at Hvidovre Hospital,
national registers and questionnaires.
Trial design Individually randomised trial sited at a large birth clinic in the Copenhagen
Capital Region, Hvidovre Hospital.
Trial intervention
The intervention will have two arms:
1. A research-based parenting program described in more detail below.
2. Standard care (control group). The pregnant woman and her partner are offered two
antenatal lectures on birth and breastfeeding in an auditorium.
The intervention arm: Groups of approximately 6-7 couples (or mothers) will meet three times
during pregnancy and 1 time 5 weeks after expected due date, for the duration of 2.5 hours
per session. (The aim is to create groups of 6-7 couples; however, due to fluctuations in
uptake groups of 4-9 couples will be deemed acceptable). The sessions will include
information and discussions about emotions and expectations related to birth and parenting,
identification of social network resources, couple communication, breastfeeding, parent-child
attachment, directions on taking care of a newborn, and recognising common signs of mood
disorders and how to react. A website with parenting information and exercises will be
created and parents will be encouraged to use this material alongside the sessions. In
addition to gaining knowledge about issues related to birth and parenting, and creating an
environment where parents can discuss their feelings and concerns, the program aims at
enhancing expectant parents' awareness of their own resources and problem-solving strategies.
Furthermore the way the groups are composited will enable participants to establish relations
with other expectant parents in their local area. All sessions will be led by a midwife. The
postnatal session will be conducted in collaboration with a health visitor, to increase
knowledge on available resources in the local communities Informed consent All participants
considered for this trial will be provided with written and oral information on this trial so
that participants can make an informed decision about their participation in this trial. A
project phone line will be established where participants can contact a project member
throughout the trial if she has further questions, or wishes to withdraw her consent for
participation in the trial.
Data collection Data will be collected from both parents using web-based questionnaires at:
baseline (approximately 18 weeks gestation) (Tp0), 37 weeks gestation (Tp1), 9 weeks after
expected due date (Tp2), 6 months after expected due date (Tp3), 1 year after expected due
date (Tp4). Participants will be contacted via e-mail, when due to answer a questionnaire.
Two reminders will be sent via additional e-mails, the first after a week and the second
after 14 days. Data will also be obtained from the hospital obstetric database and the
national registers.
Concomitant medication/treatment All participants are free to make use of concomitant
antenatal/postnatal services and parent groups. As use of other services and parent groups
may influence the outcomes that we are interested in, use and services will be examined,
documented and given careful consideration in the analyses.
Explorative outcomes
In addition to primary and secondary outcomes, there are following explorative outcomes:
Post-natal depressive symptomatology and anxiety - questionnaire data, EPDS (tp0,1,2)
Breastfeeding - questionnaire data (tp0,1,2,3) Use of healthcare services i.e.: for the
parents obstetric intervention i.e. augmentation of labour, vacuum extraction, caesarean rate
- data from the hospital obstetric database (tp2), and contact to healthcare professionals
for depressive symptomatology and unscheduled postnatal visits- questionnaire data (tp2,3).
Family medicine use - questionnaire data (tp2,3) and register data (tp4) Smoking -
questionnaire data (tp1,2,3,4) Satisfaction with relationship and family break-ups -
questionnaire data (tp 0,1,2,3,4), and data from the national registers on divorce and
break-ups (tp4): mental well-being (tp1,2,3,4)
In this trial the intermediate outcomes of interest are:
Parenting resources: trust in own ability to cope with: 1) birth (tp1), 2) discharge (tp1) 3)
parenting (tp1,2,4) breastfeeding (tp0,1); couple communication (tp0,1,2,3,4); social
support/network (tp0,1,2,3,4) Statistical plan and data analysis Sample size and power
estimations We are planning a trial of independent experimental and control participant with
1 control per experimental participant. 2011 data from the HH Obstetric Database (unpublished
data) indicate that epidural use among pregnant women is 31%. If the true epidural use for
experimental participants is 25%, we will need to include 1,175 experimental participants and
1,175 control participants be able to reject the null hypothesis that the epidural use for
experimental and control participants are equal with probability (power) 90%. The Type I
error probability associated with this test of this null hypothesis is 5% Amendment 17th
February 2014: Due to slow recruitment, we reduce the power from 90% to 80%, thus reducing
the sample size from 2,350 participants to 1,756 participants.
Power estimation for the secondary outcome Perceived Stress Scale We are planning a trial
with 1175 experimental participants and 1175 control participants. In a previous study the
Perceived Stress Scale response within each participant group was normally distributed with
standard deviation 6 (18). If the true difference in the experimental and control means is 1,
we will be able to reject the null hypothesis that the population means of the experimental
and control groups are equal with probability (power) 98.1%. The type 1 error probability
associated with this test of this null hypothesis is 0.5.
Power estimation for the secondary outcome Swedish Parenthood Stress Questionnaire In a
previous study the Swedish Parenthood Stress Questionnaire response within each subject group
was normally distributed with standard deviation 0.5 (19). If the true difference in the
experimental and control means is 0.1, we will be able to reject the null hypothesis that the
population means of the experimental and control groups are equal with probability (power)
99.8%. The type 1 error probability associated with this test of this null hypothesis is 0.5.
Power estimation for the secondary outcome Parenting Alliance Measure In a previous study the
Parenting Alliance Measure response within each subject group was normally distributed with
standard deviation 20. If the true difference in the experimental and control means is 4, we
will be able to reject the null hypothesis that the population means of the experimental and
control groups are equal with probability (power) 98.7%. The type 1 error probability
associated with this test of this null hypothesis is 5%.
Statistical methods Reporting will follow the guidelines of the CONSORT-statement.
Statistical analyses will be intention to treat as well as per protocol. The level of
significance will be 0.05.
The analysis of the primary binary outcome will be done using logistic regression.
The results of this analysis will be subjected to a worst case and a best case scenario
analysis of the potential impact of missing values. In the analysis of the two secondary
outcome measures a mixed model with repeated measures will be used. The fixed effects will
include a linear and a quadratic time component and their corresponding interactions with the
intervention indicator. An unstructured covariance matrix will be used initially. If
convergence cannot be obtained the spatial power law covariance structure will be tried and
then the compound symmetric model.
Using the general linear univariate model it will be tested if the mean values differ between
the two intervention groups at time 1 (9 weeks following birth).
If the assumptions of the above analyses cannot be fulfilled with reasonable approximation
the groups will only be compared at time 1 using a nonparametric test (Mann Whitney).
The unadjusted analyses are the primary analyses. If possible all analyses will be repeated
adjusted for the protocol specified stratification variable and the baseline value.
Three explorative subgroup analyses may be conducted in each case provided the subgroup
interacts significantly with the intervention.
Dealing with multiplicity, gate keeping will be used to adjust the observed p values for
primary and secondary outcomes. Both observed and adjusted p values will be reported.
Direct access to source data/documentation
The trial will be carried out in accordance with the Declaration of Helsinki in its latest
form as well as national laws and regulations. The investigators permit audits and inspection
by providing direct access to source data/documentation. The trial will be monitored by an
unrelated research group at the National Institute of Public Health. eCRFs will be checked,
and as minimum the following will be monitored locally:
All patients for existence (If the CPR number is correct), All patients for documented
informed consent
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