Preventing Depression in the Children of Depressed African American Mothers

Depression Clinical Trial

Official title:

Children of Depressed Mothers: Culture & Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904917
• Other study ID #: 2004-10-4041
• Secondary ID: K01MH068619DSIR
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2009
• Last updated: October 17, 2014
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2014
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children Depression Inventory (CDI)	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)	Yes
Primary	Multidimensional Anxiety Scale for Children (MASC)	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)	No
Secondary	Understanding Mood Disorders Questionnaire (UMDQ)	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)	No
Secondary	Child's Report on Parental Behavior Inventory (CRPBI)	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)	No