Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04169334 |
| Other study ID # |
H-18021300 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 19, 2019 |
| Est. completion date |
January 21, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Copenhagen University Hospital, Hvidovre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It is well documented that the formation of the early relation between parents and infant has
a significant impact on the child's mental, social and cognitive development and
competencies. The early relationship formation in the first year in the infants' life gets
the best conditions when parents are able to interpret, understand and respond to the infants
signal adequately. Symptoms of mental illness can affect a person's ability to respond to
their environment and thereby their parenting capabilities. Research have found that parental
psychopathology may interfere with a healthy interaction with the infant by reducing the
ability to be sensitively attuned and responsive to the infant's signal, needs and cues due
to the nature of the psychiatric symptoms.
The aim of this study is to investigate what potential lies within the postpartum stay at the
obstetric department and in the transition to the primary health care sector for vulnerable
families and to develop an intervention that will help increase the parents sensitivity
towards their new born infant in order to enter a healthy early relationship formation which
will be measureable on short term in the prevalence of maternal post-partum depression.
The study is a prospective mixed-method study consisting of three sub-studies. The first
study is a register-based study which aims to investigate how the proportion and the absolute
risk of children with predefined adverse developmental outcomes is distributed between
families defined as level three or four compared to families defined as level one and two.
The second study aims to uncover needs and preferences of the vulnerable families and to
investigate the experiences of the health care professionals. It is explored by in-depth
family interviews with families discharged from the obstetric department and focus group
interviews with health care professionals (nurses and health visitors) who are responsible
for the care delivered to vulnerable families. Subsequently an intervention study will be
developed, adapted, implemented and evaluated. The intervention will be carried out at the
obstetric department at Hvidovre hospital and in transition to the primary healthcare sector
using components from family focused nursing (FFN) and neonatal behavioral observational
sessions (NBO) in addition to what have appeared in the two first sub-studies. The aim of the
intervention is to facilitate family consciousness of their resources'' and increase parental
sensitivity in order to foster the best possible prerequisites for a healthy early
relationship formation between parent and infant.
The study population consists of mothers with anxiety or depression diagnosis giving birth at
Hvidovre hospital.
The register-based study will provide population based information on the characteristics of
vulnerable families focusing on the adverse outcomes for the children. The qualitative
interviews will contribute with in-depth knowledge about preferences and experiences in
relation to the care offered within the extended stay at the obstetric department and in the
transition to primary health care sector and everyday life for vulnerable families.
The enactment, implementation and evaluation of the intervention will determine whether the
combination of FFN, NBO and improved collaboration between the obstetric department and the
health visitor is associated with increased family function and increased parental
sensitivity among parents in the intervention group compared to the control group. Effect
from baseline (24-48 hours post-partum) to follow-up (3 months post-partum) will be measured
on both the mother, the parents and the infant focusing on depression symptoms (primary
outcome), parental stress, parental reflective function, mother-baby interaction, couple
relationship satisfaction, infants' self-regulation, family function and breastfeeding
Descriptive statistics will be applied in order to detect associations. Power calculations
showed that with a significance level of 5% and a power of 80% 55 families are needed in the
control and the intervention group, respectively, in order to detect statistically
difference.
This PhD study will contribute with a new perspective on the potential of the time
immediately after birth and the potential effect of early intervention to improve
prerequisites for increased family function and early healthy relationship formation for
vulnerable families. The study will provide knowledge and experience about the practical
application of both FFN and NBO at the obstetric department which have never been done in a
Danish context before. It is expected that the study as a whole may impact and benefit
clinical nursing as well a public health.
Description:
Background The formation of the early relation between parents and infant has a significant
impact on the infant's mental, social and cognitive development and competencies. Parental
psychopathology may interfere with a healthy interaction by reducing the ability to be
sensitively attuned to the infant's signal and needs due to the nature of the psychiatric
symptoms. A healthy psycho-social development starts in the perinatal period in which the
parent-infant interactions comprise of one of the most influential experiences which make
infants vulnerable and exposed to mental health risks in a lifespan perspective.
International research has found that the consequences of being born by a mother suffering
from mental illness influences on the infant's risks of developing psychopathology,
developmental disorders, and problems related to the social negative heritage. In order to
initiate preventive programs, the long-term effects of being born by a vulnerable mother need
to be investigated to target and design effective interventions. In a Danish context it is
also of interest to investigate how the proportions of children with poorer developmental
outcomes are distributed between vulnerable and not-vulnerable families.
It is well-documented that early intervention improves the prognosis for infants of
vulnerable families and short-term programs consisting of a moderate number of sessions aimed
at improving interaction are especially effective in enhancing parental sensitivity and
infant attachment security. Furthermore, the World Health Organization recommends that new
families are supported in the development of a healthy parent-infant relationship. The
postpartum period has been identified as particularly important for the establishment of
early healthy parent-infant relationship and health professionals at the obstetric department
(obs. dept.) and health visitors in the primary health care sector are in a perfect position
to initiate intervention programs that enhances this. Understanding and identifying the
quality of the parent-infant relationship is important in both hospital setting and in the
primary health care sector which also demands knowledge-sharing across sectors to create
coherence. In Denmark the antenatal care is differentiated according to the recommendations
from the National Board of Health, offering families categorized as level three and four an
extended stay at the obs. dept. following birth. Level three covers vulnerable families
comprising of families experiencing social, medical or psychological problems such as e.g.
anxiety or depression. Level four covers families experiencing complicated and severe
problems with drug abuse or severe psychiatric disorders. These families are offered an
extended stay at the obs. dept. which in most Danish hospitals are 5 days.
It is estimated that around 10-14 percentage (n= 980) of families giving birth at Hvidovre
Hospital (HVH) are vulnerable. The care and the content of the extended stay is based on
recommendations, and is not standardized. Further it has not been investigated what the
families' preferences and wishes for the extended stay consists of or what the health
professionals experience when taking care of vulnerable families at the obs. dept. The
transition to the primary health care sector is also not standardized and trading of
information and observation are not ensured.
Vulnerable families need support in the relationship formation . A mentally ill mother
demands activation and involvement of the family as a resource to facilitate the best
possible prerequisites for a healthy relationship formation with the infant. Substantial
evidence have formed an understanding that treatment of postnatal depression might require
specific parenting components to benefit child outcome. In addition, some studies have found
that intervention programs designed specifically towards improvement of the mother-infant
relationship in the context of postnatal depression benefit both the relationship formation
and reduces the negative effects of maternal depression on child development. Therefore it is
assumed that a combination of a family approach assessing family resources and a relationship
based tool that helps parents read their infants self-regulatory cues resulting in an
enhanced relationship-formation may decrease the prevalence of maternal post-partum
depression.
Aim The aim of this study is to investigate how the extended postpartum stay at the obs.
dept. and the transition to the primary health care sector can be optimized for vulnerable
families. Furthermore, to develop and test an intervention program that aim to increase
parental sensitivity and facilitate a healthy early relationship formation with their infant
which may reduce depressive symptoms among vulnerable mothers.
The aim of the study will be achieved by answering the following research questions:
1. To which extent can adverse child developmental outcomes be predicted by the
vulnerability groups?
2. How do health care professionals experience the extended stay at the obstetric
department and the transition to the primary healthcare sector?
3. Does a standardized program offered at the obstetric department containing elements from
NBO and FFN and a systematic transition to primary health care improve prerequisites for
a healthy early relationship formation between parents and infant and thereby reduced
depressive symptoms among vulnerable mothers?
Sub-study 1: Register-based study Being born by a vulnerable mother is associated with
adverse child developmental outcomes and being born into a vulnerable family may have wide
ranging effects on child development. These effects include impairment in cognitive
performance, behavior disturbances and mental problems that may persist into late childhood
and adolescence. However, it is of interest to investigate if the classification of
vulnerable groups, the strategy used by the antenatal care to predict vulnerable groups and
designing intervention programs only aiming at these groups is enough.
This study aim to investigate how the proportion and the absolute risk of children with
predefined adverse developmental outcomes is distributed between families defined as level
three or four compared to families defined as level one and two according to the to the
antenatal care defined by The National Board of Health . Adverse child developmental outcomes
will be defined completion of ninth grade before age 18, grade point average at the
ninth-grade exams in Danish public and private schools and social professional interventions
in the home. The study is conducted as a national register-based cohort study with a study
population consisting of all Danish children born from 1980-2015. Data will be extracted from
the Medical Birth Registry, the Danish National Patient Registry and Statistics Denmark's
Registries. Descriptive statistics will be applied using STATA (StataCorp. 2015). The study
will be carried out in collaboration with an epidemiological research unit at the University
of Copenhagen that has great experience with register-based research.
Sub-study 2: Interviews The interview-study aim to uncover the experiences of the health care
professionals.
Focus group interviews. Two focus group interviews (FGI) will be held of 2 hours
respectively. Both with 3-5 nurses from the obs. dept. and 3-5 health visitors from
collaborating municipalities. In total 12-20 participators.
The FGI will take place at the hospital and will be facilitated by two researchers (PhD
student and senior researcher). An interview-guide will be developed to guide the discussions
and the FGI will be digitally recorded. Data will be analyzed using content analysis
Sub-study 3: Intervention study The intervention study is designed as a feasibility study,
that aim to test and put the developed intervention program into practice. The study will
investigate enquiries related to content, recruitment, applicability of the outcome measures,
time-frame and follow-up period, reasoning and adaptability of statistics. Further the study
is unique in terms of complexity and collaboration across sectors. The health professionals
from the obs. dept. will be trained to carry out the intervention program. Data on the on the
control group will be collected prior launch of the intervention program to prevent bias and
to ease the logistic concerning organization of the health professionals at the obs. Dep. The
control group consists of women giving birth at HVH meeting the same criteria as the
intervention group and they will receive care as usual.
The intervention program comprises of results and knowledge gathered from sub-study 1 and 2,
standardized transition to primary health care sector and the beneath listed components:
Family-focused nursing. The theoretical framework is the philosophy of Family Centered Care
(FCC). It embraces respect and equality, shared responsibility, knowledge-sharing,
cooperation and partnership between health care professionals and families. Family Focused
nursing (FFN) is the practical application of delivering FCC. Assessing family resources,
coping strategies and processes relating to relations and communications among family
members, through FFN conversations provides the foundation of assisting families in their
adaption and attainment of a higher level of family function, support, health and well-being.
FFN conversations are based on systems theory, change theory and communication theory using
genograms to map the structure of the family and used as a basis for the subsequent
interventions.
Newborn behavioral observation System (NBO) The NBO is an individualized, infant-focused,
family-centered and systematic observational system that is designed to be used by health
professionals to assist, elicit and describe the newborns' competencies and individuality,
with the explicit goal of strengthening the relationship between parents and the infant and
it has been developed as a means of supporting parents in the transition to parenthood. The
NBO system comprises of 18 neuro-behavioral observations of the infant when sleeping, being
awake or crying. Combining FFN and NBO in an intervention program will increase focus on the
family's resources and ensure that the infant gets an explicit voice that is thought to
increase parental sensitivity and thereby decrease the risk of maternal post-partum
depression.
The intervention program is thought as preventive and aim to increase parental sensitivity
expressed as a lower prevalence of maternal postpartum depression symptoms. In total10 health
professionals from the obs. dept. will be theoretically and practically educated in the
methods: FFN (3days) and certified in the NBO (3days). The intervention program delivered to
the intervention group participators consists of FFN conversations and NBO sessions that will
be structured throughout the stay at the obs. dept. At the first day following birth an
admission dialogue is held with the family that implies a FFN conversation. On the second,
third and fourth day of the stay NBO sessions will be held with the family. On the third day
the NBO session will be combined with another FFN conversation and on the last day of the
stay a transition dialogue will be held together with a health visitor from the family's home
municipality. This transition dialogue will contain a FFN conversation. The conversations and
sessions will vary in length (but are estimated to last around 45 minutes per conversation)
and content and will be shaped by the needs and preferences of the family. The
transition-dialogue on the day of discharge will be held to ensure that important
observations, knowledge and concerns are shared with the family and between the health
professionals. Contact and formal agreements with the collaborating communities will be made
prior launch of the intervention program.
Descriptive statistics will be applied using STATA (StataCorp. 2015) and T-tests, Chi2 and
regression analysis will be performed and when relevant comparison will be controlled for
confounding. Process evaluation is applied to ensure that the intervention program is
delivered according to the intention. During the intervention period documentation for held
FFN conversations and NBO sessions will be collected and ongoing evaluation will register
drop-outs or recruiting problems. Besides the PhD student will randomly witness both FFN
conversations and NBO sessions in order to ensure intended content.
The sample size is calculated on the basis of the difference between the control and the
intervention group on the maternal Edinburg Postnatal Depression scale (EPDS) at follow-up.
It is estimated that the prevalence of an elevated EPDS score will be 50% in the study
population due to the inclusion criteria (42,43) and a power calculation shows that with a
significance level of 5 % and a power of 80% 55 participating and followed-up families in
both the control and the intervention group is needed to detect significant difference (N =
110). Ethics: Participating families are informed about the purpose of the study and will
receive both oral and written information about the study prior participation. The study will
be reported to the Committee on Health Research Ethics and the Danish Data Protection Agency.
Perspectives Combining research from three sub-studies this PhD study will increase the
understanding of how the time immediate after birth may facilitate family consciousness of
their resources' and help evolve early healthy relationship formation. This study will be the
first to implement and adapt FFN and NBO to a high-risk population at an obs. dept. in
Denmark. Furthermore, it is expected that this study will impact and profile clinical
