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

Study Overview
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Brief Summary
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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: 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: The decreased rate of major depression in the Project REACH group compared to the control program group will be sustained through one year postpartum. Adolescent mothers in Project REACH compared to the control program group will have higher levels of maternal-child bonding.

Detailed Description
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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.

Official Title
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Preventing Postpartum Depression in Adolescent Mothers

Conditions
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Postpartum Depression

Intervention / Treatment
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* Behavioral: Interpersonal therapy-based treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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<br>* 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)<br>* Other names: REACH 2;|
| Active Comparator: Control<br>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<br>* 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)<br>* Other names: REACH 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of depression | Outcome assessment using KID-SCID | within 6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of depressive symptoms | Outcomes assessment using CDRS | pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized trial, Postpartum depression, Adolescent pregnancy, Interpersonal psychotherapy