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Depression Prevention Program for American Indian Adolescents During and After Pregnancy

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ClinicalTrials.gov Identifier: NCT00183547
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 29, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Depression Pregnancy Behavioral: "Living in Harmony" depression prevention program Behavioral: Depression-prevention education and support Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Depression Prevention in Pregnant American Indian Teens Using CBT
Study Start Date : January 2005
Actual Primary Completion Date : March 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
"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
Active Comparator: 2
Depression-prevention education and support
Behavioral: Depression-prevention education and support
Weekly therapy sessions offering general depression-prevention education and support



Primary Outcome Measures :
  1. Postpartum depression [ Time Frame: up to 24 weeks postpartum ]


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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Johns Hopkins University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Golda Ginsburg, PhD Johns Hopkins Center for American Indian Health

Responsible Party: Golda Ginsburg, PhD, Johns Hopkins Center for American Indian Health
ClinicalTrials.gov Identifier: NCT00183547     History of Changes
Other Study ID Numbers: R34MH071300 ( U.S. NIH Grant/Contract )
R34MH071300 ( U.S. NIH Grant/Contract )
DSIR 84-CTP
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: December 2008

Keywords provided by Johns Hopkins University:
Postpartum Depression
Postpartum Period
Indians, North American
Adolescent
Female
CBT

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders