Depression Prevention Program for American Indian Adolescents During and After Pregnancy

NCT ID: NCT00183547

Last Updated: 2013-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Depression Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

"Living in Harmony" depression prevention program

Group Type EXPERIMENTAL

"Living in Harmony" depression prevention program

Intervention Type BEHAVIORAL

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

2

Depression-prevention education and support

Group Type ACTIVE_COMPARATOR

Depression-prevention education and support

Intervention Type BEHAVIORAL

Weekly therapy sessions offering general depression-prevention education and support

Interventions

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"Living in Harmony" depression prevention program

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

Intervention Type BEHAVIORAL

Depression-prevention education and support

Weekly therapy sessions offering general depression-prevention education and support

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Johns Hopkins Center for American Indian Health

Principal Investigators

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Golda Ginsburg, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Center for American Indian Health

Locations

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Johns Hopkins Center for American Indian Health

Whiteriver, Arizona, United States

Site Status

Johns Hopkins Center for American Indian Health

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R34MH071300

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 84-CTP

Identifier Type: -

Identifier Source: secondary_id

R34MH071300

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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