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Completed

NCT Number: NCT01482832

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

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.

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Key information

Conditions

Postpartum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

12 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interpersonal therapy-based treatment

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. (5 weekly sessions with a booster session postpartum)

Other names: REACH 2

Primary outcomes

  1. Diagnosis of depression

    Time frame: within 6 months postpartum

    Outcome assessment using KID-SCID

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Collaborators

  • Brown University
  • National Institute of Mental Health (NIMH)
  • Pacific Institute for Research and Evaluation

Registry information

Official study title

Preventing Postpartum Depression in Adolescent Mothers

Acronym: REACH 2

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Dec 1, 2011
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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