Clinical trial NCT02121496: Social Circumstances, Parenting Techniques, and Infant Development
Official title: Social Circumstances, Parenting Techniques, and Infant Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Infant Development
Rhythm; Sleep
Keywords: Depression
Development
Infant sleep
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: The Robin Hood Foundation
First posted: 2014-04-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

   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.

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 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.)

Primary outcomes:
measure: Change in maternal mood and prevalence/severity of postpartum depression.
timeFrame: 6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum
Secondary outcomes:
measure: The effect of behavioral intervention for infants on infant development
timeFrame: 4 months (infant age)
measure: The effect of behavioral intervention on infant sleep and fuss behavior
timeFrame: 6 weeks, 4 months (infant age)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: NYPI, CUMC
name: Catherine Monk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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