CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 target
Drug / intervention
Resources for Postpartum Parentingbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02121496
NCT02121496N/ACompleted

Social Circumstances, Parenting Techniques, and Infant Development

New York State Psychiatric Institute·interventional·Posted Apr 23, 2014·Updated Jan 28, 2020

In Brief

A clinical study evaluating Resources for Postpartum Parenting for Postpartum Depression and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 23, 2014
Enrollment StartMar 1, 2014
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 12.2 years ago

Interventions

Resources for Postpartum Parentingbehavioral

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.