Social Circumstances, Parenting Techniques, and Infant Development

Completed · Not applicable

Conditions studied: Postpartum Depression, Infant Development, Rhythm; Sleep

In brief

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.

Key facts

Study ID

NCT02121496

Run by

New York State Psychiatric Institute

People needed

60

Starts

2014-03-01

Expected to finish

2019-12-01

Last updated by the study team

2020-01-28

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.)

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.