NCT00183547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 29, 2013

Status Verified

December 1, 2008

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

May 28, 2013

Conditions

Keywords

Postpartum DepressionPostpartum PeriodIndians, North AmericanAdolescentFemaleCBT

Outcome Measures

Primary Outcomes (1)

  • Postpartum depression

    up to 24 weeks postpartum

Study Arms (2)

1

EXPERIMENTAL

"Living in Harmony" depression prevention program

Behavioral: "Living in Harmony" depression prevention program

2

ACTIVE COMPARATOR

Depression-prevention education and support

Behavioral: Depression-prevention education and support

Interventions

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

1

Weekly therapy sessions offering general depression-prevention education and support

2

Eligibility Criteria

Age15 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of major depressive disorder
  • Current psychiatric disorder or condition requiring intervention or treatment
  • Current participation in another mental or behavioral health study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Center for American Indian Health

Whiteriver, Arizona, 85941, United States

Location

Johns Hopkins Center for American Indian Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

DepressionDepression, Postpartum

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Golda Ginsburg, PhD

    Johns Hopkins Center for American Indian Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

January 1, 2005

Primary Completion

March 1, 2007

Study Completion

September 1, 2007

Last Updated

May 29, 2013

Record last verified: 2008-12

Locations