Depression Prevention Program for American Indian Adolescents During and After Pregnancy

Study Overview
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Brief Summary
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This study will determine the effectiveness of the Living in Harmony depression prevention program in preventing depressive symptoms among pregnant American Indian adolescents during pregnancy and after giving birth.

Detailed Description
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Pregnancy among reservation-based American Indian adolescents has become increasingly common. Numerous psychosocial and environmental factors have put this population at high risk for pregnancy-related depression. Depression during pregnancy and after giving birth is associated with reduced quality of life for both young mothers and their children. Many reservations lack mental health services; therefore, an inexpensive intervention is needed to prevent depressive symptoms among pregnant adolescents who live on reservations. The duration of this study will vary for each participant, depending on the time of study entry. Participants will be randomly assigned to receive weekly sessions of either the Living in Harmony program, consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support; or general depression-prevention education and support. Participants' depressive symptoms will be assessed at study entry, at 4, 12, and 24 weeks after giving birth, and study completion. Interviews and self-report scales will be used to assess participants.

Official Title
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Depression Prevention in Pregnant American Indian Teens Using CBT

Conditions
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Depression, Pregnancy

Intervention / Treatment
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* Behavioral: Living in Harmony depression prevention program
* Behavioral: Depression-prevention education and support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At 28th week or earlier of pregnancy Center for Epidemiologic Studies-Depression Scale (CES-D) score of 16 or higher Identified (by others and by self) as an American Indian Currently live on an American Indian reservation Parent or guardian willing to give consent, if applicable Willing and able to comply with all study requirements Exclusion Criteria: Diagnosis of major depressive disorder Current psychiatric disorder or condition requiring intervention or treatment Current participation in another mental or behavioral health study

Ages Eligible for Study
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Minimum Age: 15 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Living in Harmony depression prevention program | Behavioral: Living in Harmony depression prevention program<br>* Weekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support<br>|
| Active Comparator: 2<br>Depression-prevention education and support | Behavioral: Depression-prevention education and support<br>* Weekly therapy sessions offering general depression-prevention education and support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum depression |  | up to 24 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Depression, Postpartum Period, Indians, North American, Adolescent, Female, CBT