Preventing Depression in the Children of Depressed African American Mothers - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00904917

Purpose

This study will test a program for preventing depression from developing in the children of depressed African American mothers.

Condition	Intervention
Depression	Behavioral: Family Prevention Program Behavioral: Psychoeducation

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

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Negative cognitions [ Time Frame: Measured at baseline, after 1 month of treatment, and at post-treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	November 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Participants will take part in a family prevention program for the families of children with a depressed African American mother.	Behavioral: Family Prevention Program Eight 1-hour sessions, tailored as required to meet the clinical and cultural needs of each family; other family members, such as fathers, spouses, and grandparents, will be invited to participate in the intervention
Active Comparator: 2 Participants will receive education about depression.	Behavioral: Psychoeducation Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family

Detailed Description:

The children of depressed women are at an increased risk of developing depression, in addition to other psychological disorders. Studies show that this effect may occur cross culturally, and studies of African American mothers with depression show that their parenting is limited in structure and involvement. Depression may be transmitted from parent to child through exposure to the depressed parent's negative cognitions, behaviors, and affect and through stressors of daily life that accompany living with a depressed person. Previous studies of depression prevention programs for the children of depressed mothers have proved effective in changing negative behaviors and attitudes. This study will test a depression prevention program modified to treat the children of depressed, African American mothers.

Participation in this study will last 2 months. Participants will be randomly assigned to receive either an eight-session family-based prevention program or a two-session education control program. Both programs will involve the 8- to 14-year-old child of a depressed African American mother and any other adult family members who want to be involved. Participants in the family-based prevention program and their families will meet weekly with a study therapist to learn about depression, its impact on the family, coping with life stresses, and thinking skills. Although the treatment always will have the same core elements, it will be tailored to meet the clinical and cultural needs of each family. The education program will involve two meetings, one 4 weeks and one 6 weeks after enrollment, with a study researcher. Participants and their families in the education program will only receive information on depression and its impact on the family.

Participants will complete assessments at baseline, after 1 month of treatment, and post-treatment. These assessments will include interviews and questionnaires for both children and adults about family functioning, environment, and the child.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria for Mothers:

African American
Has primary current or past-year DSM-IV diagnosis of major depressive disorder, dysthymic disorder, or depressive disorder not otherwise specified (NOS)
Parent or guardian and primary caregiver of a child 8 to 14 years old
Has resided at least part time for the past year with the targeted child
May be receiving psychopharmacological treatment, psychosocial services, or both

Inclusion Criteria for Children:

Has an African American mother with a depressive disorder
8 to 14 years old
Resides at least part time with mother

Exclusion Criteria for Mothers:

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

Exclusion Criteria for Children:

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

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

Contacts

Contact: Rhonda C. Boyd, PhD	215-590-3945	boydr@email.chop.edu
Contact: Thananya D. Wooden, BS	267-426-0289	wooden@email.chop.edu

Locations

United States, Pennsylvania
The Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rhonda C. Boyd, PhD 215-590-3945 boydr@email.chop.edu
Contact: Thananya D. Wooden, BS 267-426-0289 wooden@email.chop.edu
Principal Investigator: Rhonda C. Boyd, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Rhonda C. Boyd, PhD

Children's Hospital of Philadelphia

More Information

Publications:

Boyd, R. C., Wooden, T. D., Munro, M., Liu, T., & Ten Have, T. (2008). The impact of community violence exposure on anxiety in children of mothers with depression. Journal of Child and Adolescent Trauma, 1, 287-299.

Responsible Party:	Rhonda C. Boyd, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00904917 History of Changes
Other Study ID Numbers:	K01 MH068619, DSIR 8K-RTCT, IRB NO: 2004-10-4041
Study First Received:	May 19, 2009
Last Updated:	June 25, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

African American Mothers
Children
African American Families
Parental Depression
Preventive Intervention

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012