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Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers

NCT01482832 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2019-04-24

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Interpersonal therapy-based treatment

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. (5 weekly sessions with a booster session postpartum)

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Pacific Institute for Research and Evaluation

    collaborator OTHER

  • Brown University

    collaborator OTHER

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Maureen G Phipps, MD, MPH · Women & Infants Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2017-12-31
Completion
2018-10-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01482832 on ClinicalTrials.gov