Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06116747 |
| Other study ID # |
P-2022-792 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 31, 2023 |
| Est. completion date |
December 31, 2027 |
Study information
| Verified date |
November 2023 |
| Source |
Hvidovre University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose is to support first-time fathers of premature infants in early parenthood by
promoting early paternal-infant relationships. Improve paternal confidence by involving,
knowledge sharing, and guiding them in their premature infants' emotional, nutritional, and
developmental needs.
The study operates with two study populations: a) first-time fathers, their premature
infants, and families, b) health care professionals working with new families in neonatal
intensive care units and maternity units and the families' health visitors from the secondary
health care sectors. Seven hospitals located in Denmark's five regions participates.
Four studies address the key questions for the father's involvement in supportive health
care: 1) How do fathers experience their participation in father-groups in the NICU, 2) What
are the first-time fathers' needs and preferences for supporting health care, 3) Development
of an intervention based on the identified need to support the fathers in early parenting, 4)
Study the process and effect of the intervention on paternal confidence and stress.
The first question is explored in a qualitative evaluation of an ongoing father-group
intervention in a neonatal intensive care unit. The following three questions are studied
through an action research approach, identifying first-time fathers' needs for support and
the current practices among health professionals towards new first-time fathers of premature
infants. Secondly, developing guiding principles for health care professionals to strengthen
fathers' partnership in health care. Finally, conducting a quasi-experimental study to
evaluate the process and effect of the proposed approaches. The study of this paternal
supportive programme, involves perspectives that have not yet been studied in Denmark or
internationally.
Description:
Project description The overall aim of this research study is to identify, develop and
evaluate whether supportive strategies for first-time fathers (FTF) of preterm infants will
improve parental confidence, mood and anxiety as well as increasing paternal reflective
function, and improve infants social-emotional competencies during admission in the Neonatal
Intensive Care Unit (NICU), or Maternity Unit (MU) and follow up at home by health visitors
in the municipalities in all five regions in Denmark. Thus, improve paternal confidence in
the father role by involving, knowledge sharing, and guiding them in their infants'
emotional, nutritional, and developmental needs.
Background Developing paternal confidence and engaging in the paternal role is pivotal to
men's transition into fatherhood (1). The change in fatherhood culture from breadwinner to
being involved in the care of the infant is challenging (2-4). Among first-time parents,
fathers express more insecurity than mothers (5). Fathers of preterm infants experience even
more insecurity as it is more difficult to read the infant's cues (6). Fathers have unique
support needs that are frequently unmet (5,7), which may result in decreased mental health,
father-infant interaction, and parenting confidence (7). In the health care system, they
often feel like bystanders (4) even though they want a participating role to attach to the
infant (8).
In Denmark, about 4.200 of 60.000 infants (7%) are born preterm (9). Preterm infants are
admitted to the hospital for weeks or months due to immaturity of the organs. Information,
emotional and practical support from healthcare professionals (HCP) are needed to enhance
parents' experiences, well-being, caring, and confidence during admission and at home (10).
Studies on fathers' involvement in early interventions of their preterm infant are limited
(11). Generally, interventions that extend over a long period of time and include both
primary and secondary sectors are the most effective (12). Studies have addressed parental
relationships and insecurity and sought interventions to improve parents' opportunities to
actively participate in care, showing positive effects, e.g., skin-to-skin helps fathers gain
confidence in the paternal role (13). Across sections nurses, midwives, and health visitors
provide early parenting support to all new families. There is a need to change the culture
among HCP to increase the engagement of the father in a family-focused approach, and this
requires the identification of changeable factors among HCPs in primary and secondary sectors
like knowledge, attitudes, and behavior (14). Perceptions of fathers as important as the
mother in early parenting are associated with favorable attitudes toward including them in
family interventions; this association is mediated by the professionals' perception of their
confidence (15).
Health- and socio-economic arguments exist for improving early paternal engagement, and
fathers want to be engaged, attentive, and caring (16). Their involvement in fatherhood can
benefit the health and well-being of both himself, the mother, and the infant (17). Fathers'
engagement has been shown to improve social and relational functioning in childhood, decrease
behavioral problems in adolescence, and increase educational outcomes (18,19).
Even though the Nordic countries have been at the forefront of involving fathers in pregnancy
and delivery, evidence shows that fathers are still not included and approached by HCP
equally to mothers. This project which works at and within all levels in the healthcare
sector and across the country, has the potential to take the next step to a partnership with
FTF of preterm infants by changing practice and culture to benefit the fathers, preterm
infants, and families.
Setting, recruitment and participants The recruitment period of first-time fathers and their
partners starts November 6th 2023 and is expected to be completed late July 2027 by health
professionals at the NICU in participating hospital settings in all Danish regions where
preterm infants are admitted. Eligible yearly from hospitals of Aalborg/Gødstrup (n=150),
Aarhus (n=155), Odense (n=80), Slagelse (n=75), Holbæk (n=50), Roskilde (n= 80),
Rigshospitalet (n=140) and Hvidover (n=170), and municipalities in the hospitals' catchment
areas. About 40% are FTFs, and about 12% not fulfilling the inclusion criteria. When a total
of 900 families will be eligible yearly there is a good possibility to recruit 266 families
in both groups in the recruitment period. Eight hospitals representing all Regions in Denmark
and municipalities in their catchment areas will participate.
The primary study population consists of FTF and their preterm infants (i.e., infants born
alive before 37 weeks of pregnancy). Inclusion criteria: Danish-speaking FTF to preterm
infants admitted to a NICU. Exclusion criteria: parents unable to manage their own legal
affairs and not living at home. The secondary study population consists of nurses and
midwives at hospitals and health visitors in the municipalities. For the time and activity
schedule (see appendix 1).
Framework This project will use the Medical Research Councils' (MRC) framework for developing
and evaluating complex interventions as the overall frame of reference (20), including
developing, feasibility testing, implementing, and evaluating the intervention. This national
study comprises three interlinked studies, including an intended and beneficial collaboration
between FTF and HCP across sectors from the NICU and health visitors from the municipalities.
The project may promote a joint responsibility agreement between health care providers from
municipalities and hospitals with the aim to promote knowledge and skills across sectors
about caring for new family with preterm infants. New knowledge and skills might promote both
groups confidence and motivation working with first-time fathers of preterm infants. Each
study forms the foundation of the following study that ensures a constant focus on the
context, existing practice, and feasibility of the planned study activities.
STUDY 1 - THE ASSESSMENT PHASE AND STUDY 2 - THE DEVELOPMENTAL PHASE We expect the
intervention to be supported by technology and to include a training program for HCPs
describing how to deliver the intervention as intended. The training program is expected to
include a) an implementation manual, b) e-learning and face-to-face training, and c)
supervision workshops. Based on prior studies (13,31,32), the intervention for fathers is
expected to contain; a) Guidance in understanding the infant's strengths and needs concerning
care, feeding, sleeping, and comfort; b) support to build a healthy father-infant
relationship and c) strengthening of fathers in being fathers while supporting the mothers.
However, this will be elucidated and adjusted according to pilot testing and the findings of
studies 1 and 2.
STUDY 3 - THE IMPLEMENTATION AND EVALUATION PHASE Implementation and evaluation of the
developed intervention. The content and format of the intervention is shaped by the outcomes
of study 1 and 2.
Aim The aim is to explore whether the intervention has positive effects on fathers and
infants' well-being and to unfold barriers and facilitators of the implementation through
process evaluation.
Implementation and evaluation The manual for the HCP from municipalities and hospitals, the
training course, and the supervision workshop during the intervention period ensure that both
sectors deliver the program as intended.
The effect evaluation explores whether the intervention has positive effects on the father
and the infant and thereby determines the success of the project. We hypothesize that a
tailored intervention, developed according to the identified needs, will increase paternal
confidence and mood and reduce anxiety and stress. Moreover, it will increase the father's
capacity to mentalize in the early father-infant relationship, improve the infant's
socio-emotional behavior, as well as increase exclusive breastfeeding rates at two weeks and
four months of corrected age. Parallel to the effect evaluation a process evaluation will be
conducted with the aim to evaluate fathers' and health professionals' experiences with the
study. Furthermore, to determine whether the project has been implemented as intended.
Methods An effect evaluation of the intervention will be performed in a quasi-experimental
design with the following outcome measures: Primary outcome: Paternal confidence (KPCS)
(33,34). Secondary outcomes: Family assessment (FAD) (35,36). Paternal stress scale (37,38),
reflective functioning (PRFQ) (39), depressive symptoms (GS) (40), and child social and
emotional development (ASQ:SE) (41). We also collect data from the mothers to make sure that
increased focus on the father does not negatively impact her. Data on the comparison group
will be collected alongside the development of the intervention to avoid spillover effects.
Sample size The power calculation is based on the primary outcome. Instruments measuring
early confidence concerning early fatherhood are unknown. Twenty-five percent of new mothers
have a risk score <37 on the KPCS scale. First-time fathers have been shown to be more
insecure than new mothers (39,40). We estimate that 60% of first-time fathers to preterm
infants have a risk score <37 on the KPCS scale. With a significance level of 5% and a power
of 80%, the power calculation finds a need for 173 participating first-time fathers in each
group to be able to identify a statistically significant difference decrease of 15% in
reporting low confidence as a father. To be able to account for potential confounders (age,
marital status, educational background, and employment), 10 fathers will be added per
confounder giving 213 in each group. Additionally, accounting for the expected loss to follow
up of 20 % gives a final need of 266 fathers in each group.
Statistical methods The effect of the intervention on the primary outcome, paternal
confidence scale, will be analyzed by chi-squared test on distribution for <37 and ≥37
between intervention and comparison groups. To evaluate possible confounders, a logistic
regression model will be used. If the confounding effect is more than 10%, the variable is
included in the final model. The secondary outcomes will be compared using a t-test or
Wilcoxon rank sum test if normality assumption is not satisfied. Confounders will be
evaluated with the same procedure as for KPCS, with linear regression used instead of
logistic regression.
Analysis of qualitative data Interview data will be analyzed using systematic text
condensation, which consists of four steps: (I) read transcripts repeatedly to identify
themes; (II) identify and code units of meaning; (III) identify sub-groups of codes from step
II and develop condensates from them; and (IV) describe experiences based on the condensates.
Process evaluation Alongside the effect evaluation, a process evaluation will be conducted to
assess the reach, dose, and fidelity of the intervention to unfold facilitators and barriers
to implementation as well as the influence of contextual factors.
Ethics Approval from the Danish Committees on Health Research Ethics was not required for
this project (journal no.: F-22055527). Permission has been obtained from the Danish Data
Protection Agency via Pactius, the Capital Region of Copenhagen (journal no.: P-2022-792).
Data will be collected through a REDCap database, and all data will be stored in the hospital
server's logged drive. Permission to use the different internationally validated
questionnaire scales will be obtained from the copyright holders. According to the
Declaration of Helsinki, data will be handled anonymously, and written informed content will
be obtained from all participants.
