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Depression Prevention Program for American Indian Adolescents During and After Pregnancy
This study has been completed.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00183547
  Purpose

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

MedlinePlus related topics: Depression
U.S. FDA Resources
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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Postpartum depression [ Time Frame: Measured at 4, 12, and 24 weeks postpartum ] [ Designated as safety issue: No ]

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
1: Experimental
"Living in Harmony" depression prevention program
Behavioral: "Living in Harmony" depression prevention program
Weekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support
2: Active Comparator
Depression-prevention education and support
Behavioral: Depression-prevention education and support
Weekly therapy sessions offering general depression-prevention education and support

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183547

Locations
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
Sponsors and Collaborators
Investigators
Principal Investigator: Golda Ginsburg, PhD Johns Hopkins Center for American Indian Health
  More Information

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

Keywords provided by National Institute of Mental Health (NIMH):
Postpartum Depression
Postpartum Period
Indians, North American
Adolescent
Female
CBT

Study placed in the following topic categories:
Depression
Depression, Postpartum
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 15, 2009