Social Circumstances, Parenting Techniques, and Infant Development

NCT02121496 | Completed DMC

• 1 other identifier: #6889
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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:
2. 2.The feasibility of applying this protocol with a low SES population
3. 3.The effectiveness of the intervention compared to usual care
4. 4.If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development
5. 5.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.

Conditions

Postpartum Depression; Infant Development; Rhythm; Sleep

Keywords

Depression; Development; Infant sleep

Outcome Measures

Primary Outcomes (1)

• Change in maternal mood and prevalence/severity of postpartum depression.

  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.

  6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum

Secondary Outcomes (2)

• The effect of behavioral intervention for infants on infant development

  4 months (infant age)

• The effect of behavioral intervention on infant sleep and fuss behavior

  6 weeks, 4 months (infant age)

Study Arms (2)

Resources for Postpartum Parenting

EXPERIMENTAL

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

Control Group

NO INTERVENTION

This group will not receive the coaching tips to help babies cry less and sleep more.

Interventions

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.

Also known as: Practical Resources for Effective Postpartum Parenting

Resources for Postpartum Parenting

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• The Robin Hood Foundation: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

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MeSH Terms

Conditions

Depression, Postpartum; Depression

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Catherine Monk, Ph.D.

  NYPI, CUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Psychology

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 23, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

US (1)