Social Circumstances, Parenting Techniques, and Infant Development
Primary Purpose
Postpartum Depression, Infant Development, Rhythm; Sleep
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resources for Postpartum Parenting
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Depression focused on measuring Depression, Development, Infant sleep
Eligibility Criteria
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.)
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Resources for Postpartum Parenting
Control Group
Arm Description
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.
This group will not receive the coaching tips to help babies cry less and sleep more.
Outcomes
Primary Outcome Measures
Change in maternal mood and prevalence/severity of postpartum depression.
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
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
The infant's sleep and fuss/cry behavior will be assessed at 6 weeks and 16 weeks of age (Baby Day Diary)
Full Information
NCT ID
NCT02121496
First Posted
March 28, 2014
Last Updated
January 27, 2020
Sponsor
New York State Psychiatric Institute
Collaborators
The Robin Hood Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02121496
Brief Title
Social Circumstances, Parenting Techniques, and Infant Development
Official Title
Social Circumstances, Parenting Techniques, and Infant Development
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
The Robin Hood Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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:
The feasibility of applying this protocol with a low SES population
The effectiveness of the intervention compared to usual care
If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Infant Development, Rhythm; Sleep
Keywords
Depression, Development, Infant sleep
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resources for Postpartum Parenting
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will not receive the coaching tips to help babies cry less and sleep more.
Intervention Type
Behavioral
Intervention Name(s)
Resources for Postpartum Parenting
Other Intervention Name(s)
Practical Resources for Effective Postpartum Parenting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in maternal mood and prevalence/severity of postpartum depression.
Description
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.
Time Frame
6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum
Secondary Outcome Measure Information:
Title
The effect of behavioral intervention for infants on infant development
Description
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.
Time Frame
4 months (infant age)
Title
The effect of behavioral intervention on infant sleep and fuss behavior
Description
The infant's sleep and fuss/cry behavior will be assessed at 6 weeks and 16 weeks of age (Baby Day Diary)
Time Frame
6 weeks, 4 months (infant age)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Monk, Ph.D.
Organizational Affiliation
NYPI, CUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
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Social Circumstances, Parenting Techniques, and Infant Development
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