Clinical trial NCT00904917: Preventing Depression in the Children of Depressed African American Mothers
Official title: Children of Depressed Mothers: Culture & Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: African American Mothers
Children
African American Families
Parental Depression
Preventive Intervention
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-05-20
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Mothers:

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

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:

Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Children Depression Inventory (CDI)
timeFrame: Measured at baseline and at post-treatment (8 weeks after baseline)
measure: Multidimensional Anxiety Scale for Children (MASC)
timeFrame: Measured at baseline and post-treatment (8 weeks after baseline)
Secondary outcomes:
measure: Understanding Mood Disorders Questionnaire (UMDQ)
timeFrame: Measured at baseline and post-treatment (8 weeks after baseline)
measure: Child's Report on Parental Behavior Inventory (CRPBI)
timeFrame: Measured at baseline and post-treatment (8 weeks after baseline)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Rhonda C. Boyd, PhD
role: PRINCIPAL_INVESTIGATOR
References: