Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01379781
First received: June 22, 2011
Last updated: August 14, 2014
Last verified: February 2013
  Purpose

Postpartum depression (PPD) is undertreated and the consequences of this are substantial for women and children. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. In this study, the investigators are teaching parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to women likely to develop PPD to see if the investigators can prevent the onset of this disorder.


Condition Intervention
Postpartum Depression
Behavioral: Behavioral Intervention for PPD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Symptoms of Depression (with postpartum onset) measured by Standardized Clinical Interview for the DSM-IV [ Time Frame: 16 weeks postpartum ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: August 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Intervention for PPD
Behavioral Intervention for PPD delivered over 3 in-person sessions.
Behavioral: Behavioral Intervention for PPD
We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
Other Name: Preventative Behavioral Intervention for PPD.
Active Comparator: Treatment As Usual
Referred to Treatment in the Community.
Behavioral: Behavioral Intervention for PPD
We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
Other Name: Preventative Behavioral Intervention for PPD.

Detailed Description:

Of the over 4 million live births each year in the United States, nearly 800,000 — or 20% — of the mothers will develop major or minor depression within the first 3 months postpartum. This number dwarfs prevalence rates for gestational diabetes (2-5%) and preterm birth (12.7%). Existing clinical approaches to postpartum depression (PPD) use standard pharmacologic and psychological interventions to reduce women's symptoms. Nevertheless, PPD is undertreated, in part because women are reluctant to seek treatment due to stigma associated with mental health care and disinclination to take psychotropic medications when breastfeeding. The consequences of this are substantial. Untreated PPD is associated with diminished quality of life and significant emotional suffering for women, and, through compromised caregiving, poor outcomes in children's cognitive and social-emotional development. Although maternal risk factors for PPD are well known, protocols for prevention based on commonly used depression interventions are only beginning to be evaluated. Building on developmental data showing the profound bi-directionality of emotional and behavioral influences between mother and infant, the investigators are testing a novel PPD intervention protocol that challenges the standard, individually-focused treatment paradigm. Our intervention is based on the conceptualization of PPD as a potential disorder of the dyad, and one that can be approached through behavioral change in and affective engagement with mother and child. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. The investigators aim to collect data on a novel PPD risk-reducing protocol based on a dyadic behavioral approach to PPD in which the investigators treat at-risk women by promoting maternally-mediated behavioral changes in their infants. The investigators will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits, then evaluate infant behavior at 6 and 14 weeks, and maternal mood at 6, 10, and 14 weeks postpartum. The investigators will fully exploit the investigative opportunities of this intervention study by using state-of-the-art EEG and fetal monitoring to characterize early biomarkers associated with infant behavior and behavior change. This study has the potential to have a major impact on clinical research, and to transform the standard care of PPD in that (1) the intervention will have high rates of treatment compliance because (a) the protocol sessions can be incorporated into usual perinatal medical visits, (b) parenting skills will appeal to women as a non-psychiatric intervention, (c) the clinical approach will have face validity given the dyadic focus of the perinatal period; (2) its aim is prevention; (3) it fosters both maternal and child well being; (4) it will expand the risk factors for PPD to include neurobehavioral markers in the perinate.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, non-smoking pregnant women
  • Ages 18-35
  • Score of 28 or higher on the Predictive Index of Postnatal Depression
  • Low to normal obstetric risk
  • Before 34 weeks gestation

Exclusion Criteria:

  • High Risk pregnancy
  • Taking medications that affect the cardiovascular system (α blockers, β blockers, corticosteroids
  • Chronic-use asthma medications (e.g. beta2-adrenoceptor agonists)
  • Smoking during pregnancy
  • Illicit drug/alcohol use during pregnancy
  • Taking any psychotropic medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379781

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Catherine E Monk, Ph.D. Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01379781     History of Changes
Other Study ID Numbers: 6285
Study First Received: June 22, 2011
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
prevention
postpartum depression

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

ClinicalTrials.gov processed this record on October 19, 2014