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Completed

NCT Number: NCT02121496

Social Circumstances, Parenting Techniques, and Infant Development

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.

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Key information

Conditions

Postpartum Depression Behavior Behavioral Symptoms Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Infant Development Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Rhythm; Sleep Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Resources for Postpartum Parenting

Behavioral

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 names: Practical Resources for Effective Postpartum Parenting

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • The Robin Hood Foundation

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2014
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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