Preventing Depression in the Children of Depressed African American Mothers

NCT00904917 | Completed Phase 1 Results DMC

• 4 other identifiers: 2004-10-4041K01MH068619DSIR 8K-RTCTIRB NO: 2004-10-4041
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

African American Mothers; Children; African American Families; Parental Depression; Preventive Intervention

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (2)

• Understanding Mood Disorders Questionnaire (UMDQ)

  Measured at baseline and post-treatment (8 weeks after baseline)

• Child's Report on Parental Behavior Inventory (CRPBI)

  Measured at baseline and post-treatment (8 weeks after baseline)

Study Arms (2)

Adapted PIP

EXPERIMENTAL

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

Lecture

ACTIVE COMPARATOR

Mothers received psychoeducation about depression. The intervention was psychoeducation.

Behavioral: Psychoeducation

Interventions

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.

Adapted PIP

Psychoeducation BEHAVIORAL

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

Lecture

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Have an African American mother with a depressive disorder
• to 14 years old
• Reside at least part time with mother
• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

Small sample size; Inadequate power to detect changes between groups; No-intervention comparison group; Differential attrition in the two groups favoring the comparison group

Results Point of Contact

• Title: Rhonda C. Boyd, Ph.D.
• Organization: Children's Hospital of Philadelphia

boydr@email.chop.edu

215-590-3945

Study Officials

• Rhonda C. Boyd, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 20, 2009
• Study Start: February 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 20, 2014
• Results First Posted: October 20, 2014

Record last verified: 2014-10

Locations

US (1)