Social Circumstances, Parenting Techniques, and Infant Development
NCT ID: NCT02121496
Last Updated: 2020-01-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-03-31
Study Completion Date
2019-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Postpartum Depression
Infant Development
Rhythm; Sleep
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Investigators
Study Groups
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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.
Group Type
EXPERIMENTAL
Resources for Postpartum Parenting
Intervention Type
BEHAVIORAL
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.
Control Group
This group will not receive the coaching tips to help babies cry less and sleep more.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Practical Resources for Effective Postpartum Parenting
Eligibility Criteria
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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)
* 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.)
* 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.)
Minimum Eligible Age
18 Years
Maximum Eligible Age
45 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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New York State Psychiatric Institute
OTHER
Sponsor Role
lead
The Robin Hood Foundation
UNKNOWN
Sponsor Role
collaborator
Responsible Party
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Catherine Monk
Professor of Medical Psychology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Catherine Monk, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
NYPI, CUMC
Locations
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Columbia University Medical Center
New York, New York, United States
Site Status
Countries
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United States
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Other Identifiers
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#6889
Identifier Type: -
Identifier Source: org_study_id
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