Social Circumstances, Parenting Techniques, and Infant Development

January 27, 2020 updated by: Catherine Monk, New York State Psychiatric Institute

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy pregnant women between 24 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 - $47,700 annual for a family of 4 (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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maternal mood and prevalence/severity of postpartum depression.
Time Frame: 6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum
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.
6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of behavioral intervention for infants on infant development
Time Frame: 4 months (infant age)
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.
4 months (infant age)
The effect of behavioral intervention on infant sleep and fuss behavior
Time Frame: 6 weeks, 4 months (infant age)
The infant's sleep and fuss/cry behavior will be assessed at 6 weeks and 16 weeks of age (Baby Day Diary)
6 weeks, 4 months (infant age)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

The Robin Hood Foundation

Investigators

  • Principal Investigator: Catherine Monk, Ph.D., NYPI, CUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #6889

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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