Look - Your Baby is Talking to You.

NCT04169334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2022-07-20

No results posted yet for this study

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.

Conditions

  • Depression, Postpartum

Interventions

BEHAVIORAL

Prolonged planned program for the stay at the obstetric department

A five day planned and designed program delivered to the family while at the obstetric department.

Sponsors & Collaborators

  • Copenhagen University Hospital, Hvidovre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2022-01-21
Completion
2022-01-21

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169334 on ClinicalTrials.gov