Skip to main content
OpenTrials
Completed

NCT Number: NCT00183547

Depression Prevention Program for American Indian Adolescents During and After Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Center for American Indian Health, Whiteriver, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Living in Harmony" depression prevention program

Behavioral

Weekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support

Depression-prevention education and support

Behavioral

Weekly therapy sessions offering general depression-prevention education and support

Primary outcomes

  1. Postpartum depression

    Time frame: up to 24 weeks postpartum

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Depression Prevention in Pregnant American Indian Teens Using CBT

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.