The Northern Babies Longitudinal Study

NCT02538497 | Completed

• 1 other identifier: 2015/614REK nord
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NBO; The Newborn Behavioral Observation; postpartum depression; postnatal depression; child development; parent-child interaction

Outcome Measures

Primary Outcomes (1)

• Levels of postpartum depression

  Mothers and fathers self-reported levels of postpartum depression measured with the Edinburgh Postnatal Depression Scale.

  Six weeks postpartum

Secondary Outcomes (13)

• Levels of postpartum depression

  Four months postpartum

• Levels of postpartum depression

  Six months postpartum

• Parental reflective functioning

  Six weeks postpartum

• Parental reflective functioning

  Four months postpartum

• Bonding between parent and child

  Six weeks postpartum

Study Arms (2)

NBO plus routine care

EXPERIMENTAL

The Newborn Behavioral Observation

Behavioral: The Newborn Behavioral Observation (NBO); Behavioral: Routine care

Routine care

OTHER

Behavioral: Routine care

Interventions

The Newborn Behavioral Observation (NBO) BEHAVIORAL

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.

Also known as: NBO

NBO plus routine care

Routine care BEHAVIORAL

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

NBO plus routine care; Routine care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant woman and expecting fathers
• Speak Norwegian

You may not qualify if:

• Do not speak Norwegian

Sponsors & Collaborators

• University of Tromso: lead
• Public Health Sisters in the Tromsø municipality: collaborator
• University Hospital of North Norway: collaborator

Study Sites (1)

UiT The Arctic University of Norway

Tromsø, Norway

Location

Related Publications (2)

• Hoifodt RS, Nordahl D, Landsem IP, Csifcsak G, Bohne A, Pfuhl G, Rognmo K, Braarud HC, Goksoyr A, Moe V, Slinning K, Wang CEA. Newborn Behavioral Observation, maternal stress, depressive symptoms and the mother-infant relationship: results from the Northern Babies Longitudinal Study (NorBaby). BMC Psychiatry. 2020 Jun 15;20(1):300. doi: 10.1186/s12888-020-02669-y.

  PMID: 32539729 DERIVED

• Hoifodt RS, Nordahl D, Pfuhl G, Landsem IP, Thimm JC, Ilstad LKK, Wang CEA. Protocol for the Northern babies longitudinal study: predicting postpartum depression and improving parent-infant interaction with The Newborn Behavioral Observation. BMJ Open. 2017 Sep 27;7(9):e016005. doi: 10.1136/bmjopen-2017-016005.

  PMID: 28963284 DERIVED

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 Officials

• Catharina EA Wang, Professor

  UiT The Arctic University of Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: September 2, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 17, 2019

Record last verified: 2019-04

Locations

NO (1)