This trial is active, not recruiting.

Conditions postpartum depression, infant development, rhythm; sleep
Treatment resources for postpartum parenting
Sponsor New York State Psychiatric Institute
Collaborator The Robin Hood Foundation
Start date March 2014
End date April 2017
Trial size 60 participants
Trial identifier NCT02121496, #6889


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
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.
resources for postpartum parenting Practical Resources for Effective 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.
(No Intervention)
This group will not receive the coaching tips to help babies cry less and sleep more.

Primary Outcomes

Change in maternal mood and prevalence/severity of postpartum depression.
time frame: 6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum

Secondary Outcomes

The effect of behavioral intervention for infants on infant development
time frame: 4 months (infant age)
The effect of behavioral intervention on infant sleep and fuss behavior
time frame: 6 weeks, 4 months (infant age)

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.)

Additional Information

Official title Social Circumstances, Parenting Techniques, and Infant Development
Principal investigator Catherine Monk, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by New York State Psychiatric Institute.