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The Northern Babies Longitudinal Study

NCT02538497 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2019-05-17

No results posted yet for this study

Summary

Postpartum depression (PPD) is a prevalent disorder. Studying the factors related to PPD will help to identify families at risk and provide preventive interventions. This can in turn improve the developmental trajectories for the children. Several previous studies have investigated risk factors for PPD. However, few studies have focused on cognitive vulnerability factors. The first aim of the present study is to explore a range of protective and risk factors, including cognitive factors, for PPD, parent-infant interactions and child development. The second aim of the study is to evaluate the effectiveness of The Newborn Behavioral Observation (NBO) as a universal preventive intervention delivered in routine practice. The NBO is a brief relationship-enhancing intervention that may reduce depressive symptomatology in mothers.

Conditions

  • Depression, Postpartum

Interventions

BEHAVIORAL

The Newborn Behavioral Observation (NBO)

The Newborn Behavioral Observation (NBO) is a flexible parental guidance methodology which takes between 20 and 40 minutes to administer. It consists of 18 neurobehavioral observations which give a profile of the infant´s behavioral repertoire along the dimensions: attentional-interactional, autonomic, motor and state organization. The intervention group will receive 3 NBO consultations: 1) Routine care plus the NBO at the hospital within two days post-delivery; 2) Routine home visit plus the NBO by a public health nurse when the infant is 7-10 days old; and 3) NBO at the well-baby clinic when the infant is about 4 weeks old.

BEHAVIORAL

Routine care

The control group will receive routine care. Between 7 and 10 days after birth a public health nurse routinely visits the family at home. Six weeks after birth, the mother and the infant visit the well-baby clinic

Sponsors & Collaborators

  • Public Health Sisters in the Tromsø municipality

    collaborator UNKNOWN

  • University Hospital of North Norway

    collaborator OTHER

  • University of Tromso

    lead OTHER

Principal Investigators

  • Catharina EA Wang, Professor · UiT The Arctic University of Norway

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Norway

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 NCT02538497 on ClinicalTrials.gov