NCT00436150

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

2.6 years

First QC Date

February 14, 2007

Last Update Submit

March 8, 2013

Conditions

Keywords

AdolescentsDepression, postpartum

Outcome Measures

Primary Outcomes (1)

  • Postpartum depression diagnosis

    Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum

Secondary Outcomes (3)

  • Degree of depressive symptoms

    Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum

  • Prenatal distress

    Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum

  • Social support

    Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum

Study Arms (2)

A

EXPERIMENTAL

Participants will receive interpersonal therapy-based treatment

Behavioral: Interpersonal therapy-based treatment

B

ACTIVE COMPARATOR

Participants will receive standard care

Behavioral: Standard care

Interventions

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.

Also known as: REACH
A
Standard careBEHAVIORAL

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.

Also known as: Baby Basics
B

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Less than 24 weeks pregnant
  • Not currently being treated for depression
  • Speaks and reads English fluently

You may not qualify if:

  • Currently receiving mental health services from a health care provider
  • Meets DSM-IV criteria for an affective disorder, substance use disorder, or psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

DepressionDepression, Postpartum

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Maureen Phipps, MD

    Women and Infants Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 16, 2007

Study Start

February 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations