A Family Depression Prevention Program (FDP)
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|ClinicalTrials.gov Identifier: NCT02021578|
Recruitment Status : Recruiting
First Posted : December 27, 2013
Last Update Posted : May 3, 2018
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 fewer onsets of depressive episodes and lower levels of anxious/depressive symptoms 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 :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Family Cognitive Behavioral Prevention of Depression in Youth and Parents|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
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 onset of a depressive episode. In parents, the primary outcome is time in a depressive episode. [ Time Frame: up to two years ]
For child participants, we will assess time to onset of a depressive disorder (e.g., Major Depressive Episode; persistent depressive disorder) using a semi-structured clinical interview, the Longitudinal Interval Follow-up Evaluation (LIFE).
For parent participants, we also will use the LIFE to measure the amount of time in a depressive episode during the assessment interval.
- Parents: Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: past two weeks ]Parent participants: The PHQ-9 measures 9 symptoms of depression on a 4-point scale. Scores can range from 0 to 36.
- Children: Youth Self-report (YSR) anxiety/depression subscale [ Time Frame: six months ]Children will complete the YSR, which is a self-report checklist containing 112 items scored on a 3-point scale.
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||Recruiting|
|San Diego, California, United States, 92120-4913|
|Contact: Robin Weersing, PhD 619-594-8892 email@example.com|
|Principal Investigator: Robin Weersing, PhD|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203-5721|
|Contact: Judy Garber, PhD 615-343-0595 firstname.lastname@example.org|
|Contact: Bruce Compas, PhD 615-322-8306 Bruce.Compas@Vanderbilt.edu|
|Principal Investigator: Judy Garber, PhD|
|Principal Investigator: Bruce Compas, PhD|
|Principal Investigator:||Judy Garber, PhD||Vanderbilt University|
|Principal Investigator:||Bruce Compas, PhD||Vanderbilt University|
|Principal Investigator:||Robin Weersing, PhD||San Diego State University|