Depression Prevention Program for American Indian Adolescents During and After Pregnancy

Johns Hopkins University

Status: Completed

Conditions: Depression; Pregnancy

Treatments: Behavioral: Depression-prevention education and support; Behavioral: "Living in Harmony" depression prevention program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00183547

DSIR 84-CTP

R34MH071300 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 15 to 19 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

1

Experimental group

Description:

"Living in Harmony" depression prevention program

Treatment:

Behavioral: "Living in Harmony" depression prevention program

2

Active Comparator group

Description:

Depression-prevention education and support

Treatment:

Behavioral: Depression-prevention education and support