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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00183547 |
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.
Condition | Intervention |
---|---|
Depression Pregnancy |
Behavioral: "Living in Harmony" depression prevention program Behavioral: Depression-prevention education and support |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Depression Prevention in Pregnant AI Teens Using CBT |
Estimated Enrollment: | 45 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | September 2007 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
"Living in Harmony" depression prevention program
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Behavioral: "Living in Harmony" depression prevention program
Weekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support
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2: Active Comparator
Depression-prevention education and support
|
Behavioral: Depression-prevention education and support
Weekly therapy sessions offering general depression-prevention education and support
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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.
Ages Eligible for Study: | 15 Years to 19 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Johns Hopkins Center for American Indian Health | |
Whiteriver, Arizona, United States, 85941 | |
United States, Maryland | |
Johns Hopkins Center for American Indian Health | |
Baltimore, Maryland, United States, 21205 |
Principal Investigator: | Golda Ginsburg, PhD | Johns Hopkins Center for American Indian Health |
Responsible Party: | Johns Hopkins Center for American Indian Health ( Golda Ginsburg, PhD ) |
Study ID Numbers: | R34 MH71300, DSIR 84-CTP |
Study First Received: | September 13, 2005 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00183547 |
Health Authority: | United States: Federal Government |
Postpartum Depression Postpartum Period Indians, North American |
Adolescent Female CBT |
Depression Depression, Postpartum Mental Disorders |
Mood Disorders Depressive Disorder Behavioral Symptoms |