Text Size

Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers (REACH 2)

This study is currently recruiting participants.
Verified April 2013 by Women and Infants Hospital of Rhode Island
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Pacific Institute for Research and Evaluation
Brown University
Information provided by (Responsible Party):
maureen phipps, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01482832
First received: November 25, 2011
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

The Specific Aim of this proposal 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.

Condition Intervention
Postpartum Depression
 Behavioral: Interpersonal therapy-based treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Postpartum Depression in Adolescent Mothers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Diagnosis of depression [ Time Frame: within 6 months postpartum ] [ Designated as safety issue: No ]
    Outcome assessment using KID-SCID


Secondary Outcome Measures:
  • Degree of depressive symptoms [ Time Frame: pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52 ] [ Designated as safety issue: No ]
    Outcomes assessment using CDRS


Estimated Enrollment: 324
Study Start Date: December 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
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 5 weekly sessions and have a brief booster session postpartum.
 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)
Other Name: REACH 2
Active Comparator: Control
Behavioral: Standard care Participants assigned to receive standard care will focus on prenatal education including issues associated with pregnancy and postpartum. Both groups will attend 5 weekly sessions and have a brief booster session postpartum.
 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)
Other Name: REACH 2

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, conducted over five years, 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.

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482832

Contacts
Contact: Maureen Phipps, MD, MPH 401-274-1122 ext 1575 mphipps@wihri.org
Contact: Crystal Ware 401-274-1122 ext 2855 cjocelyn@wihri.org

Locations
United States, Rhode Island
Women & Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Maureen Phipps, MD, MPH     401-274-1122 ext 1575     mphipps@wihri.org    
Contact: Crystal Ware     401-274-1122 ext 2855     cjocelyn@wihri.org    
Principal Investigator: Maureen Phipps, MD, MPH            
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
National Institute of Mental Health (NIMH)
Pacific Institute for Research and Evaluation
Brown University
Investigators
Principal Investigator: Maureen G Phipps, MD, MPH Women & Infants Hospital
  More Information

No publications provided

Responsible Party: maureen phipps, Study Prinicipal Investigator, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01482832     History of Changes
Other Study ID Numbers: R01 MH093342, R01MH093342
Study First Received: November 25, 2011
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Women and Infants Hospital of Rhode Island:
Randomized trial
Postpartum depression
Adolescent pregnancy
Interpersonal psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on May 19, 2013