Clinical trial NCT00183547: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Pregnancy
Keywords: Postpartum Depression
Postpartum Period
Indians, North American
Adolescent
Female
CBT
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 45
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postpartum depression
timeFrame: up to 24 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Arizona
city: Baltimore
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Center for American Indian Health
name: Golda Ginsburg, PhD
role: PRINCIPAL_INVESTIGATOR
References: