A Family Depression Prevention Program (FDP)
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|ClinicalTrials.gov Identifier: NCT02021578|
Recruitment Status : Active, not recruiting
First Posted : December 27, 2013
Last Update Posted : February 8, 2022
The primary aim is to prevent depression in youth and parents in a single, integrated family intervention.
Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have significantly lower levels of anxious/depressive symptoms and fewer onsets of depressive episodes as compared to children in the Written Information (WI) condition.
Hypothesis 1b: In parents, the amount of time in a depressive episode will be significantly lower for those in the FDP program as compared to those in the WI condition.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Family Cognitive Behavioral Prevention Behavioral: Written information||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Interviewers who assess diagnostic outcomes are masked to participant condition.|
|Official Title:||Family Cognitive Behavioral Prevention of Depression in Youth and Parents|
|Actual Study Start Date :||December 2014|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: Family Cognitive Behavioral Prevention
A family cognitive behavioral program for parents and children. Parents learn parenting skills and cognitive behavioral techniques for managing depression. Children learn coping skills.
Behavioral: Family Cognitive Behavioral Prevention
Parent training and cognitive behavioral intervention with parents. Coping skills training with children.
Active Comparator: Written Information
Families receive written materials about depression and the effects of parental depression on children.
Behavioral: Written information
Reading materials about depression
- In children, the primary outcome is level of symptoms on the Youth Self-report form. [ Time Frame: twelve months post baseline ]For child participants, we will assess change in their levels of symptoms on the Youth Self-report form at 12-month follow-up. T-scores range from 0 to 100; higher scores indicate more symptoms (i.e., worse outcome).
- In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child [ Time Frame: 12 months ]For child participants, we will assess change in their levels of symptoms on the Child Behavior checklist at 12-month follow-up.
- Parents: Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: 12 months ]Parent participants: The PHQ-9 measures 9 symptoms of depression on a 4-point scale. Scores can range from 0 to 36.
- Children: depressive diagnoses [ Time Frame: 12 months ]Children and parents are interviewed about the child's depressive symptoms with the Longitudinal Interval Follow-up Evaluation, which yields scores 1-6 for each week.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021578
|United States, California|
|San Diego State University|
|San Diego, California, United States, 92120-4913|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203-5721|
|Principal Investigator:||Judy Garber, PhD||Vanderbilt University|
|Principal Investigator:||Bruce Compas, PhD||Vanderbilt University|
|Principal Investigator:||Robin Weersing, PhD||San Diego State University|