Depression Prevention Program for American Indian Adolescents During and After Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00183547
First received: September 13, 2005
Last updated: May 28, 2013
Last verified: December 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Depression Prevention in Pregnant American Indian Teens Using CBT

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Postpartum depression [ Time Frame: up to 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Johns Hopkins University
Investigators
Principal Investigator: Golda Ginsburg, PhD Johns Hopkins Center for American Indian Health
  More Information

No publications provided

Responsible Party: Golda Ginsburg, PhD, Johns Hopkins Center for American Indian Health
ClinicalTrials.gov Identifier: NCT00183547     History of Changes
Other Study ID Numbers: R34 MH71300, R34MH071300, DSIR 84-CTP
Study First Received: September 13, 2005
Last Updated: May 28, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 22, 2014