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Social Circumstances, Parenting Techniques, and Infant Development

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by New York State Psychiatric Institute
Sponsor:
Collaborator:
The Robin Hood Foundation
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT02121496
First received: March 28, 2014
Last updated: April 21, 2014
Last verified: March 2014
  Purpose
  1. Investigators aim to assess a novel behavioral intervention (currently approved in Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral changes in young infants to reduce the risk of postpartum depression in a group of low income women. More specifically, investigators aim to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior and thereby: (1) reduce the incidence and/or severity of postpartum maternal depression in low socioeconomic status (SES) women, and (2) improve the quality of mother-infant interaction and subsequent child development. Investigators will study:

    1. The feasibility of applying this protocol with a low SES population
    2. The effectiveness of the intervention compared to usual care
    3. If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development
  2. Investigators aim to determine whether this behavioral intervention can affect infant development as measured by neurodevelopmental assessments and cortisol reactivity at 4 months of age.

Condition Intervention
Postpartum Depression
Infant Development
Rhythm; Sleep
Behavioral: Resources for Postpartum Parenting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Social Circumstances, Parenting Techniques, and Infant Development

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in maternal mood and prevalence/severity of postpartum depression. [ Time Frame: 6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum ] [ Designated as safety issue: No ]
    Investigators will be assessing and tracking the incidence and/or severity of postpartum depression with the use of mood and stress questionnaires (Hamilton Depression Scale, Hamilton Anxiety Scale, Perceived Stress Scale, Center for Epidemiological Studies Depression Scale) administered at 4-6 weeks postpartum, 10 weeks postpartum, and 16 weeks postpartum.


Secondary Outcome Measures:
  • The effect of behavioral intervention for infants on infant development [ Time Frame: 4 months (infant age) ] [ Designated as safety issue: No ]
    Investigators will use neurodevelopmental assessments (Bayley Scale of Infant Development, Still Face Protocol, Free Play Observation, and Conjugate Kicking Task) and cortisol reactivity to assess infant development at 4 months of age.

  • The effect of behavioral intervention on infant sleep and fuss behavior [ Time Frame: 6 weeks, 4 months (infant age) ] [ Designated as safety issue: No ]
    The infant's sleep and fuss/cry behavior will be assessed at 6 weeks and 16 weeks of age (Baby Day Diary)


Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resources for Postpartum Parenting
Behavioral intervention will include techniques to help mothers get their infants to cry/fuss less and sleep more to determine if this has an effect on prevalence of postpartum depression in low SES women and if it improves the quality of mother-infant interaction and subsequent child development.
Behavioral: Resources for Postpartum Parenting
The intervention includes four-sessions that targets maternal caregiving of young infants to increase infant sleep and reduce fuss/cry behavior and thereby simultaneously consolidate women's enjoyment of and confidence in their maternal role, this, in turn, promotes a cycle of a mutually re- warding engagement in the mother-infant dyad — the antithesis of a 'toxic' experience, and a strong foundation for improving the chances of a successful psychosocial adjustment, including adequate employment. Investigators believe PREPP holds tremendous promise as an intervention to fill the science-practice gap in the promotion of an optimal emotional environment for the developing infant, particularly for women and children living in poverty and/or facing significant psychosocial hardship.
Other Name: Practical Resources for Effective Postpartum Parenting
No Intervention: Control Group
This group will not receive the coaching tips to help babies cry less and sleep more.

Detailed Description:

Developmental research consistently shows that postpartum depression has a negative impact on cognitive and emotional development during infancy and childhood. Low SES women face unique stressors and social challenges. Rates of postpartum depression are significantly higher in this group (23-33%) than in the general population (10-15%).

The purpose of this study is to understand how social circumstances, women's mood, and parenting techniques affect infant and child development. Specifically, investigators are interested in finding out whether a behavioral intervention, already being administered in IRB approved protocol #6285, targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, thereby reducing the incidence and/or severity of maternal depression and anxiety symptoms, improving the quality of the mother-infant interaction, and improving infant developmental outcomes.

By collecting stress reports from women from low SES backgrounds during pregnancy and the postpartum period and by conducting follow-up observational assessments of the quality of mother-infant interaction, infant learning, infant cortisol reactivity, and infant neurocognitive development, investigators hope to identify whether this intervention can effectively meet these aims.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy pregnant women between 36 and 38 weeks gestation (based on self-report)
  • Ages 18-45 (based on self-report) 3. English speaking (based on self-report)
  • Salary indicated to be at New York City standardized "Struggling level" or lower - $46,416 annual for a family of (based on self-report)
  • Experiencing one or more of nine social adversity hardships (based on self report)
  • Experiencing a healthy pregnancy, free from any significant medical complication (based on self-report)
  • Receiving standard prenatal care (based on self-report)

Exclusion Criteria:

  • Multi-fetal pregnancy (based on self-report)
  • Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)
  • Acute medical illness or significant pregnancy complication (based on self-report)
  • Currently in weekly, individual psychotherapy - group therapy and psychiatric management ok (based on self-report)
  • Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)
  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: NCT02121496

Contacts
Contact: Catherine Monk, Ph.D. 917-543-6031 cem31@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Catherine Monk, P.h.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
The Robin Hood Foundation
Investigators
Principal Investigator: Catherine Monk, Ph.D. NYPI, CUMC
  More Information

Publications:
Barr, R. G., Kramer, M. S., Boisjoly, C., McVey-White, L. & Pless, I. B. Parental diary of infant cry and fuss behavior. Archives of Disease in Childhood 63, 380-387 (1988).

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02121496     History of Changes
Other Study ID Numbers: 6889
Study First Received: March 28, 2014
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Depression
Development
Infant sleep

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

ClinicalTrials.gov processed this record on November 24, 2014