Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 19, 2009
October 17, 2014
February 2008
February 2009   (final data collection date for primary outcome measure)
  • 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.
Negative cognitions [ Time Frame: Measured at baseline, after 1 month of treatment, and at post-treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00904917 on ClinicalTrials.gov Archive Site
  • 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.
  • Social skills [ Time Frame: Measured at baseline and post-treatment ] [ Designated as safety issue: No ]
  • Social support [ Time Frame: Measured at baseline and post-treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Preventing Depression in the Children of Depressed African American Mothers
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Depression
  • 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.
  • Behavioral: Psychoeducation
    Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.
  • 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.

    Intervention: Behavioral: Prevention Intervention Project
  • Active Comparator: Lecture

    Mothers received psychoeducation about depression.

    The intervention was psychoeducation.

    Intervention: Behavioral: Psychoeducation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
8 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00904917
2004-10-4041, K01MH068619, DSIR 8K-RTCT, IRB NO: 2004-10-4041
Yes
Rhonda Boyd, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
National Institute of Mental Health (NIMH)
Principal Investigator: Rhonda C. Boyd, PhD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP