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Social Circumstances, Parenting Techniques, and Infant Development

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02121496
Collaborator
The Robin Hood Foundation (Other)
60
Enrollment
1
Location
2
Arms
69
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  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:

  2. The feasibility of applying this protocol with a low SES population

  3. The effectiveness of the intervention compared to usual care

  4. If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development

  5. 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 or Disease Intervention/Treatment Phase
  • Behavioral: Resources for Postpartum Parenting
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Social Circumstances, Parenting Techniques, and Infant Development
Actual Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in maternal mood and prevalence/severity of postpartum depression. [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.

    Secondary Outcome Measures

    1. The effect of behavioral intervention for infants on infant development [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.

    2. The effect of behavioral intervention on infant sleep and fuss behavior [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • New York State Psychiatric Institute
    • The Robin Hood Foundation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Catherine Monk, Professor of Medical Psychology, New York State Psychiatric Institute
    ClinicalTrials.gov Identifier:
    NCT02121496
    Other Study ID Numbers:
    • #6889
    First Posted:
    Apr 23, 2014
    Last Update Posted:
    Jan 28, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by Catherine Monk, Professor of Medical Psychology, New York State Psychiatric Institute
    Depression
    Development
    Infant sleep
    Additional relevant MeSH terms:
    Depression, Postpartum
    Depression

    Study Results

    No Results Posted as of Jan 28, 2020