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

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ClinicalTrials.gov Identifier: NCT01482832
Recruitment Status : Active, not recruiting
First Posted : December 1, 2011
Last Update Posted : May 15, 2018
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

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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Behavioral: Interpersonal therapy-based treatment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Postpartum Depression in Adolescent Mothers
Actual Study Start Date : December 2011
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Diagnosis of depression [ Time Frame: within 6 months postpartum ]
    Outcome assessment using KID-SCID


Secondary Outcome Measures :
  1. Degree of depressive symptoms [ Time Frame: pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52 ]
    Outcomes assessment using CDRS



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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482832


Locations
United States, Rhode Island
Women & Infants Hospital
Providence, Rhode Island, United States, 02905
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

Responsible Party: maureen phipps, Study Principal Investigator, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01482832     History of Changes
Other Study ID Numbers: R01MH093342 ( U.S. NIH Grant/Contract )
R01MH093342 ( U.S. NIH Grant/Contract )
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not at this point.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by maureen phipps, 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