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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00436150
Other study ID # R34MH077588
Secondary ID R34MH077588DSIR
Status Completed
Phase N/A
First received February 14, 2007
Last updated March 8, 2013
Start date February 2007
Est. completion date September 2009

Study information

Verified date March 2013
Source Women and Infants Hospital of Rhode Island
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will aim to prevent postpartum depression in pregnant teenagers through an interpersonal therapy-based program.


Description:

Postpartum depression is believed to be one of the most common complications after pregnancy. This type of depression often occurs within the first year after the baby is born and is most likely caused by dramatic changes in hormone levels after pregnancy. Pregnant teenagers are even more at risk for experiencing complications throughout pregnancy and parenting difficulties after delivery. Minimal research has been done on preventive ways to reduce postpartum depression in teenagers. Therefore, this study will evaluate the effectiveness of an interpersonal therapy-based program at preventing postpartum depression in financially disadvantaged pregnant teenagers.

Participants will first undergo a 15-minute interview about their background and emotions. Participants will undergo a second interview and then be randomly assigned to receive either interpersonal therapy-based treatment or standard care. Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. Participants assigned to receive standard care will focus more on the health issues associated with pregnancy and postpartum. Both groups will attend weekly 1-hour sessions for 5 weeks. Homework may be assigned to review topics discussed, and all participants will receive the book Baby Basics. Following treatment, participants will meet with researchers again when they are 34 to 36 weeks pregnant; in the hospital after the baby is born; and 6, 12, and 24 weeks after the baby is born.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- Less than 24 weeks pregnant

- Not currently being treated for depression

- Speaks and reads English fluently

Exclusion Criteria:

- Currently receiving mental health services from a health care provider

- Meets DSM-IV criteria for an affective disorder, substance use disorder, or psychosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Interpersonal therapy-based treatment
Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. Both groups will attend weekly 1-hour sessions for 5 weeks.
Standard care
Participants assigned to receive standard care will focus more on the health issues associated with pregnancy and postpartum. Both groups will attend weekly 1-hour sessions for 5 weeks.

Locations

Country Name City State
United States Women & Infants Hospital of Rhode Island Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Women and Infants Hospital of Rhode Island National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postpartum depression diagnosis Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum No
Secondary Degree of depressive symptoms Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum No
Secondary Prenatal distress Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum No
Secondary Social support Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum No
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