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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Women and Infants Hospital of Rhode Island
Sponsor:
Collaborators:
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: January 10, 2014
Last verified: January 2014

November 25, 2011
January 10, 2014
December 2011
April 2016   (final data collection date for primary outcome measure)
Diagnosis of depression [ Time Frame: within 6 months postpartum ] [ Designated as safety issue: No ]
Outcome assessment using KID-SCID
Same as current
Complete list of historical versions of study NCT01482832 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers
Preventing Postpartum Depression in Adolescent Mothers

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Postpartum Depression
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
  • 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.
    Intervention: Behavioral: Interpersonal therapy-based treatment
  • 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.
    Intervention: Behavioral: Interpersonal therapy-based treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
324
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Female
12 Years to 19 Years
Yes
Contact: Maureen Phipps, MD, MPH 401-274-1122 ext 41575 mphipps@wihri.org
Contact: Crystal Ware, RN, CCRP 401-274-1122 ext 42855 cjocelyn@wihri.org
United States
 
NCT01482832
R01 MH093342, R01MH093342
Yes
maureen phipps, Women and Infants Hospital of Rhode Island
Women and Infants Hospital of Rhode Island
  • National Institute of Mental Health (NIMH)
  • Pacific Institute for Research and Evaluation
  • Brown University
Principal Investigator: Maureen G Phipps, MD, MPH Women & Infants Hospital
Women and Infants Hospital of Rhode Island
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP