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

Preventing Postpartum Depression in Adolescent Mothers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01482832
Acronym
REACH 2
Enrollment
250
Registered
2011-12-01
Start date
2011-12-31
Completion date
2018-10-30
Last updated
2019-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Depression

Keywords

Randomized trial, Postpartum depression, Adolescent pregnancy, Interpersonal psychotherapy

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.

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.

Interventions

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

National Institute of Mental Health (NIMH)
CollaboratorNIH
Pacific Institute for Research and Evaluation
CollaboratorOTHER
Brown University
CollaboratorOTHER
Women and Infants Hospital of Rhode Island
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of depressionwithin 6 months postpartumOutcome assessment using KID-SCID

Secondary

MeasureTime frameDescription
Degree of depressive symptomspre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52Outcomes assessment using CDRS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026