Preventing Depression in the Children of Depressed African American Mothers
Recruitment status was Recruiting
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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 |
- Negative cognitions [ Time Frame: Measured at baseline, after 1 month of treatment, and at post-treatment ] [ Designated as safety issue: Yes ]
- 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 |
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| Contact: Rhonda C. Boyd, PhD | 215-590-3945 | boydr@email.chop.edu |
| Contact: Thananya D. Wooden, BS | 267-426-0289 | wooden@email.chop.edu |
| 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 | |
| Principal Investigator: | Rhonda C. Boyd, PhD | Children's Hospital of Philadelphia |
More Information
Publications:
| 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 May 16, 2013