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Trial record 30 of 45 for:    Postpartum Depression AND PPD | "Depression" AND "Depression"

The Northern Babies Longitudinal Study

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ClinicalTrials.gov Identifier: NCT02538497
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Public Health Sisters in the Tromsø municipality
University Hospital of North Norway
Information provided by (Responsible Party):
University of Tromso

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.

Condition or disease Intervention/treatment Phase
Depression, Postpartum Behavioral: The Newborn Behavioral Observation (NBO) Behavioral: Routine care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Northern Babies Longitudinal Study: Predicting Postpartum Depression and Improving Parent-infant Interaction With The Newborn Behavioral Observation
Actual Study Start Date : November 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NBO plus routine care
The Newborn Behavioral Observation
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.

Other Name: NBO

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

Routine care 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




Primary Outcome Measures :
  1. Levels of postpartum depression [ Time Frame: Six weeks postpartum ]
    Mothers and fathers self-reported levels of postpartum depression measured with the Edinburgh Postnatal Depression Scale.


Secondary Outcome Measures :
  1. Levels of postpartum depression [ Time Frame: Four months postpartum ]
    Mothers and fathers self-reported levels of postpartum depression measured with the Edinburgh Postnatal Depression Scale.

  2. Levels of postpartum depression [ Time Frame: Six months postpartum ]
    Mothers and fathers self-reported levels of postpartum depression measured with the Edinburgh Postnatal Depression Scale.

  3. Parental reflective functioning [ Time Frame: Six weeks postpartum ]
    Mothers and fathers self-reported parental reflective functioning measured with the Parental Reflective Functioning Questionnaire.

  4. Parental reflective functioning [ Time Frame: Four months postpartum ]
    Mothers and fathers self-reported parental reflective functioning measured with the Parental Reflective Functioning Questionnaire.

  5. Bonding between parent and child [ Time Frame: Six weeks postpartum ]
    Self-reported quality of bonding between parent and child measured with Maternal Postnatal Attachment Scale/Paternal Postnatal Attachment Scale.

  6. Bonding between parent and child [ Time Frame: Four months postpartum ]
    Self-reported quality of bonding between parent and child measured with Maternal Postnatal Attachment Scale/Paternal Postnatal Attachment Scale.

  7. Parent-child interaction [ Time Frame: Four months postpartum ]
    Parent-child interaction will be rated on the basis of 15-30 minutes videotaped episodes of parent-infant play interaction.

  8. Parental stress [ Time Frame: Six weeks postpartum ]
    Self-reported measure of parental stress.

  9. Parental stress [ Time Frame: Four months postpartum ]
    Self-reported measure of parental stress.

  10. A composite measure of the infant´s temperament [ Time Frame: Six months postpartum ]
    Parents report of infant´s sensitivity, general activity, frustration tolerance, adaptability, regularity, and soothability.

  11. Infants social withdrawal behaviour [ Time Frame: Six months postpartum ]
    Assessment of the infant`s social withdrawal behaviour with The Alarm Distress Baby Scale.

  12. Infant cognitive, communicative and motor development [ Time Frame: Six months postpartum ]
    Assessment of the infant`s cognitive, communicative and motor development with The screening test version of Bayley Scales of Infant and Toddler Development

  13. Heart rate variability [ Time Frame: Six months postpartum ]
    Mothers and infants heart rate variability will be measured with a wireless and unobtrusive electrocardiogram (ECG) equipment.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant woman and expecting fathers
  • Speak Norwegian

Exclusion Criteria:

  • Do not speak Norwegian

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538497


Locations
Norway
UiT The Arctic University of Norway
Tromso, Norway
Sponsors and Collaborators
University of Tromso
Public Health Sisters in the Tromsø municipality
University Hospital of North Norway
Investigators
Principal Investigator: Catharina EA Wang, Professor UiT The Arctic University of Norway

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT02538497     History of Changes
Other Study ID Numbers: 2015/614REK nord
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Tromso:
NBO
The Newborn Behavioral Observation
postpartum depression
postnatal depression
child development
parent-child interaction

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications