Skip to main content
Clinical Trials/NCT01482832
NCT01482832
Completed
Not Applicable

Preventing Postpartum Depression in Adolescent Mothers

Women and Infants Hospital of Rhode Island1 site in 1 country250 target enrollmentDecember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Depression
Sponsor
Women and Infants Hospital of Rhode Island
Enrollment
250
Locations
1
Primary Endpoint
Diagnosis of depression
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The Specific Aim of this study is to conduct a randomized controlled trial to evaluate whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a didactic attention-control program reduces the risk of PPD in adolescent mothers.

Primary Hypothesis:

  1. The intervention (Project REACH) will be significantly more efficacious than the control program in reducing the risk of PPD up to six months postpartum in adolescent mothers.

    Secondary Hypotheses:

  2. The decreased rate of major depression in the Project REACH group compared to the control program group will be sustained through one year postpartum.

  3. Adolescent mothers in Project REACH compared to the control program group will have higher levels of maternal-child bonding.

Detailed Description

Each year, more than 400,000 births in the United States are to mothers less than 20 years old. Alarmingly, approximately 25-36% of teen mothers experience postpartum depression (PPD), a condition associated with significant social and health morbidity. PPD places teen mothers and their children at great risk during an already challenging time in their lives. Preventing PPD in this vulnerable population is essential to improving overall health. Project REACH is a randomized controlled trial, to evaluate whether our novel preventive intervention compared to a didactic attention control reduces the risk of PPD in adolescent mothers. The intervention, REACH (Relax, Encourage, Appreciate, Communicate, Help), is based on Interpersonal Psychotherapy (IPT) and targets those factors that may play a significant role in the development of PPD in adolescent mothers (i.e., poor social support, role transitions and life stressors). The control condition includes didactic prenatal education sessions. Project REACH builds on the foundation of our NIMH-funded treatment development project and pilot study (R34 MH077588). The pilot study demonstrated feasibility, acceptability and initial efficacy in a small sample. The current R01 proposal aims to evaluate the efficacy of the Project REACH intervention in reducing the risk of PPD.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
October 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Women and Infants Hospital of Rhode Island
Responsible Party
Principal Investigator
Principal Investigator

maureen phipps

Study Principal Investigator

Women and Infants Hospital of Rhode Island

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diagnosis of depression

Time Frame: within 6 months postpartum

Outcome assessment using KID-SCID

Secondary Outcomes

  • Degree of depressive symptoms(pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52)

Study Sites (1)

Loading locations...

Similar Trials