Social Circumstances, Parenting Techniques, and Infant Development
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|ClinicalTrials.gov Identifier: NCT02121496|
Recruitment Status : Active, not recruiting
First Posted : April 23, 2014
Last Update Posted : July 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Depression Infant Development Rhythm; Sleep||Behavioral: Resources for Postpartum Parenting||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Social Circumstances, Parenting Techniques, and Infant Development|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
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 Name: 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.
- 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.
- 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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121496
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Catherine Monk, Ph.D.||NYPI, CUMC|