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Preventing Depression in the Children of Depressed African American Mothers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rhonda Boyd, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00904917
First received: May 19, 2009
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Depression
Behavioral: Prevention Intervention Project
Behavioral: Psychoeducation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Children of Depressed Mothers: Culture & Prevention

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Children Depression Inventory (CDI) [ Time Frame: Measured at baseline and at post-treatment (8 weeks after baseline) ] [ Designated as safety issue: Yes ]
    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.

  • Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Measured at baseline and post-treatment (8 weeks after baseline) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Understanding Mood Disorders Questionnaire (UMDQ) [ Time Frame: Measured at baseline and post-treatment (8 weeks after baseline) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Measured at baseline and post-treatment (8 weeks after baseline) ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Behavioral: 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.

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

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

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904917

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Rhonda C. Boyd, PhD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Rhonda Boyd, Associate Professor, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00904917     History of Changes
Other Study ID Numbers: 2004-10-4041, K01MH068619, DSIR 8K-RTCT, IRB NO: 2004-10-4041
Study First Received: May 19, 2009
Results First Received: September 26, 2013
Last Updated: October 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital of Philadelphia:
African American Mothers
Children
African American Families
Parental Depression
Preventive Intervention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 25, 2014