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Depression Prevention Program for American Indian Adolescents During and After Pregnancy

Primary Purpose

Depression, Pregnancy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

"Living in Harmony" depression prevention program

Depression-prevention education and support

About this trial

This is an interventional prevention trial for Depression focused on measuring Postpartum Depression, Postpartum Period, Indians, North American, Adolescent, Female, CBT

Eligibility Criteria

15 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Johns Hopkins Center for American Indian Health
Johns Hopkins Center for American Indian Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

"Living in Harmony" depression prevention program

Depression-prevention education and support

Outcomes

Primary Outcome Measures

Postpartum depression

Secondary Outcome Measures

Full Information

NCT ID

NCT00183547

First Posted

September 13, 2005

Last Updated

May 28, 2013

Sponsor

Johns Hopkins University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00183547

Brief Title

Depression Prevention Program for American Indian Adolescents During and After Pregnancy

Official Title

Depression Prevention in Pregnant American Indian Teens Using CBT

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

September 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Pregnancy

Keywords

Postpartum Depression, Postpartum Period, Indians, North American, Adolescent, Female, CBT

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (false)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

"Living in Harmony" depression prevention program

Arm Title

Arm Type

Active Comparator

Arm Description

Depression-prevention education and support

Intervention Type

Behavioral

Intervention Name(s)

"Living in Harmony" depression prevention program

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Depression-prevention education and support

Intervention Description

Weekly therapy sessions offering general depression-prevention education and support

Primary Outcome Measure Information:

Title

Postpartum depression

Time Frame

up to 24 weeks postpartum

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Golda Ginsburg, PhD

Organizational Affiliation

Johns Hopkins Center for American Indian Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Center for American Indian Health

City

Whiteriver

State/Province

Arizona

ZIP/Postal Code

85941

Country

United States

Facility Name

Johns Hopkins Center for American Indian Health

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

12. IPD Sharing Statement

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Depression Prevention Program for American Indian Adolescents During and After Pregnancy

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