Depression Prevention Program for American Indian Adolescents During and After Pregnancy
Depression Prevention in Pregnant American Indian Teens Using CBT
2 other identifiers
interventional
45
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Jan 2005
Typical duration for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedMay 29, 2013
December 1, 2008
2.2 years
September 13, 2005
May 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postpartum depression
up to 24 weeks postpartum
Study Arms (2)
1
EXPERIMENTAL"Living in Harmony" depression prevention program
2
ACTIVE COMPARATORDepression-prevention education and support
Interventions
Weekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support
Weekly therapy sessions offering general depression-prevention education and support
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosis of major depressive disorder
- Current psychiatric disorder or condition requiring intervention or treatment
- Current participation in another mental or behavioral health study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins Center for American Indian Health
Whiteriver, Arizona, 85941, United States
Johns Hopkins Center for American Indian Health
Baltimore, Maryland, 21205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Golda Ginsburg, PhD
Johns Hopkins Center for American Indian Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
January 1, 2005
Primary Completion
March 1, 2007
Study Completion
September 1, 2007
Last Updated
May 29, 2013
Record last verified: 2008-12