Preventing Depression in the Children of Depressed African American Mothers

NCT ID: NCT00904917

Last Updated: 2014-10-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-02-28

Brief Summary

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The purpose of the study is to adapt and test the Preventive Intervention Project for urban African American mothers with depression and their children.

Detailed Description

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Abstract

Background: There is limited representation of ethnic minorities in preventive interventions for the generational impact of maternal depression.

Methods: The Preventive Intervention Project (PIP) was adapted to be culturally and contextually relevant for urban African American mothers with depression and their children. A pilot clinical trial (PIP vs. lecture) was conducted.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Adapted PIP

Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.

The intervention was the Prevention Intervention Project.

Group Type EXPERIMENTAL

Prevention Intervention Project

Intervention Type BEHAVIORAL

Eight 1-hour sessions focused on psychoeducation, coping with stress, and cognitive-behavioral strategies. The sessions were tailored as required to meet the clinical and cultural needs of each family; other family members, such as fathers, spouses, and grandparents, were invited to participate in the intervention.

Lecture

Mothers received psychoeducation about depression.

The intervention was psychoeducation.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.

Interventions

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Prevention Intervention Project

Eight 1-hour sessions focused on psychoeducation, coping with stress, and cognitive-behavioral strategies. The sessions were tailored as required to meet the clinical and cultural needs of each family; other family members, such as fathers, spouses, and grandparents, were invited to participate in the intervention.

Intervention Type BEHAVIORAL

Psychoeducation

Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* African American
* Primary current or past-year diagnostic and statistical manual (DSM-IV) diagnosis of Major Depressive Disorder, Dysthymic Disorder, or Depressive Disorder not otherwise specified
* Parent or guardian and primary caregiver of a child 8 to 14 years old
* Resided at least part time for the past year with the targeted child
* May be receiving psychopharmacological treatment, psychosocial services, or both


* Have an African American mother with a depressive disorder
* 8 to 14 years old
* Reside at least part time with mother

Exclusion Criteria

* Current or lifetime history of schizophrenia
* Current or lifetime history of bipolar disorder
* Current or past-year diagnosis of alcohol or drug dependency
* Serious medical disorder, neurological disorder, condition, or chronic pain that prevents participation
* Documented mental retardation
* Current suicide risk sufficient to preclude outpatient treatment

Children:


* Currently in treatment for depression or an anxiety disorder
* Presence of a medical or psychiatric condition contraindicating study intervention, such as mental retardation, suicidality, or pervasive developmental disorder
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Rhonda Boyd

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rhonda C. Boyd, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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K01MH068619

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 8K-RTCT

Identifier Type: OTHER

Identifier Source: secondary_id

IRB NO: 2004-10-4041

Identifier Type: OTHER

Identifier Source: secondary_id

2004-10-4041

Identifier Type: -

Identifier Source: org_study_id

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