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Completed

NCT Number: NCT00904917

Preventing Depression in the Children of Depressed African American Mothers

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

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevention Intervention Project

Behavioral

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

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Children of Depressed Mothers: Culture & Prevention

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 20, 2009
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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