Preventing Depression in the Children of Depressed African American Mothers

Phase 1

Completed

• Conditions: Depression
• Interventions: Behavioral: Prevention Intervention Project; Behavioral: Psychoeducation

• Registration Number: NCT00904917
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Results First Submitted: 2013-09-26
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-17
• Last Update Submitted: 2014-10-17
• Results First Posted: 2014-10-20
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapted PIP	Prevention Intervention Project	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.
Lecture	Psychoeducation	Mothers received psychoeducation about depression. The intervention was psychoeducation.

Primary Outcome Measures

Name	Time	Method
Multidimensional Anxiety Scale for Children (MASC)	Measured at baseline and post-treatment (8 weeks after baseline)	Multidimensional Anxiety Scale for Children (MASC; March et al., 1997) is a self-report instrument that measures a broad range of anxiety symptoms in youth. The MASC consists of 39 items using a 4-point Likert scale that are distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety. Scores are summed and converted to T-scores. The total T score ranges from 25 to 90 with higher scores representing greater levels of anxiety.
Children Depression Inventory (CDI)	Measured at baseline and at post-treatment (8 weeks after baseline)	Children Depression Inventory (CDI; Kovacs, 1992) is a widely-used self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The CDI is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
Understanding Mood Disorders Questionnaire (UMDQ)	Measured at baseline and post-treatment (8 weeks after baseline)	Understanding Mood Disorders Questionnaire (UMDQ; Gavazzi, Fristad, \& Law, 1997) measures attributions and knowledge of symptoms, course, and treatment of mood disorders and a symptom checklist. It has 39 items and two subscales. A range of total score is 0 to 59. The first 20 questions are true/false questions and correct responses are scored 2 points each. Nineteen questions are a checklist of symptoms and correct identification of those depression and manic symptoms are scored 1 point each. All items are summed for a total score. Higher scores indicate greater knowledge of mood disorders. Both maternal and child reporters completed this measure.
Child's Report on Parental Behavior Inventory (CRPBI)	Measured at baseline and post-treatment (8 weeks after baseline)	Child's Report on Parental Behavior Inventory (CRPBI; Schludermann \& Schludermann, 1970) assesses children's and parents' perceptions of parental acceptance, permitting psychological autonomy, and level of parental control. The 10-item acceptance scale which assesses parental warmth was administered. The acceptable scale has items scored from 1 to 3 (not like me, somewhat like me, a lot like me). Items are summed with a total range is 10 to 30. Higher scores represents greater warmth exhibited by mother to child. Separate forms are available for both child and parent report.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States