An interventional study of Family Group Cognitive Behavioral and Written Information in Depression, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Prevention
This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus educational treatment in preventing depression in the children of parents with a history of depression.
Depression is a serious condition that can affect a person's work, relationships, and quality of life. Studies have shown that children of depressed parents are at a higher risk for developing depression than those whose parents have not experienced depression. Safe and effective treatments that can help prevent children of depressed parents from becoming depressed are needed. This study will compare CBT to depression education to determine which is more effective in preventing depression in the children of depressed parents.
Families will be randomly assigned to receive weekly sessions of either CBT or depression education for 12 weeks. Parents in the CBT group will be taught skills to more effectively raise their children and to better manage their depressive symptoms; their children will be taught skills to cope with the stress of their parents' depression. Families in the education group will be informed about the ways that depression can affect individuals with depression and their families.
Study visits will occur at study entry and at Week 12. Several follow-up visits will occur for up to 2 years after the interventional part of the study. At each visit, a clinician will make direct observations of the depressed parent's interaction with his or her children. In addition, families will be interviewed and will complete questionnaires about the parent's depressive symptoms and family interaction.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 304 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
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Exclusion Criteria for All Participants:
The intervention is a family group cognitive behavioral program for families of parents with a history of depression to teach parenting skills to parents and coping skills to children.
Behavioral: Family Group Cognitive Behavioral
The comparison arm involves providing written information about depression and stress to parents with a history of depression and their children.
Behavioral: Written Information
Groups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions
Families are mailed written materials that describe depression and stress in families with a depressed parent.
Internalizing and Externalizing symptoms in children
Child Behavior Checklist; Youth Self-Report; Internalizing and Externalizing Problems; Minimum T score = 40; Maximum T score = 80; Higher scores reflect worse outcome
Time frame: 12 months
Depressive symptoms in parents
Patient Health Questionnaire - 9; Total Depression Symptoms; Minimum score = 0; Maximum score = 27; Higher scores reflect worse outcomes
Time frame: 12 months
Coping skills of children
Responses to Stress Questionnaire; Secondary control coping scale; Minimum score = 4; Maximum score = 16; Higher scores reflect better outcomes
Time frame: 12 months
Parenting skills of parents
Parent-child interaction coded
Time frame: 12 months
Onset of depressive disorders in children
Interviews
Time frame: 12 months
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Vanderbilt University