Preventing Depression in the Children of Depressed African American Mothers

October 17, 2014 updated by: Rhonda Boyd, Children's Hospital of Philadelphia

Children of Depressed Mothers: Culture & Prevention

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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.
Active Comparator: Lecture

Mothers received psychoeducation about depression.

The intervention was psychoeducation.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children Depression Inventory (CDI)
Time Frame: 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.
Measured at baseline and at post-treatment (8 weeks after baseline)
Multidimensional Anxiety Scale for Children (MASC)
Time Frame: 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.
Measured at baseline and post-treatment (8 weeks after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding Mood Disorders Questionnaire (UMDQ)
Time Frame: 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.
Measured at baseline and post-treatment (8 weeks after baseline)
Child's Report on Parental Behavior Inventory (CRPBI)
Time Frame: 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.
Measured at baseline and post-treatment (8 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rhonda C. Boyd, PhD, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 17, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2004-10-4041
  • K01MH068619 (U.S. NIH Grant/Contract)
  • DSIR 8K-RTCT (NIMH DSIR)
  • IRB NO: 2004-10-4041 (Other Identifier: IRB No.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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