Look - Your Baby is Talking to You.

NCT04169334 | Completed DMC

• 1 other identifier: H-18021300
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in maternal depressive symptoms from baseline to three month postpartum

  Edinburgh postnatal depression score, rates on a four point scale from 'most of the time' to 'never' Cut off at 11. The higher the score the more depressive symptoms.

  Baseline and 3 month post partum

Secondary Outcomes (5)

• Parental Stress scale

  Baseline and 3 month post partum

• Parental reflective function

  Baseline and 3 month post partum

• Family function

  Baseline and 3 month post partum

• Infant self-regulations

  Baseline and 3 month post partum

• Process evaluation

  When the family is discharged.

Study Arms (2)

Control group

NO INTERVENTION

Group receiving care as usual

Intervention group

EXPERIMENTAL

Intervention group receiving a standardized preventive program (5 days at the Obstetric department)

Behavioral: Prolonged planned program for the stay at the obstetric department

Interventions

Prolonged planned program for the stay at the obstetric department BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Gender Eligibility Details: Women delivering at Hvidovre hospital meeting inclusion criteria
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers with ongoing or former either depression or anxiety diagnosis

You may not qualify if:

• Other psychiatric comorbidities
• Premature birth (\<37 week)
• admission to neonatal unit
• if the infant is born with syndromes or other malformations.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

COpenhagen University Hospital Hvidovre

Hvidovre, Danmark, 2650, Denmark

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Intervention study with one controlgroup and one intervention group

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 19, 2019
• Study Start: September 19, 2019
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

DK (1)