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 20, 2019

See Contacts and Locations

Sponsor:

Collaborator:

San Diego State University

Information provided by (Responsible Party):

Judith Garber, Vanderbilt University

Study Description

Brief Summary:

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

Detailed Description:

Depression is a major public health problem affecting over 15 million U.S. adults annually and is especially prevalent in those of parenting age. Offspring of depressed parents are at increased risk of depression and therefore are a critical target for preventive interventions. The current study aims to reduce the rate of depression in parents and their children by adopting an innovative, family-based approach to simultaneously preventing depression in at-risk youth and in their affected parents. The rationale for this approach is based on (a) a conceptual model that integrates parenting processes, stress (particularly that which is associated with parental depression), and children's self-regulatory skills in the face of stress, (b) evidence that depression runs in families, (c) promising results from family- and child-focused depression prevention programs, (d) evidence that in adults, cognitive-behavioral therapy (CBT) reduces both depressive episodes and their recurrence, and (e) growing consensus among scientists, clinicians, and policymakers on the need for family-based models of healthcare. This 5- year, two-site randomized controlled trial will test a Family Depression Prevention (FDP) program for children (ages 9-15) and their parents with depressive disorders (past or current). This "dual prevention" approach is a novel synthesis of existing evidence-based intervention techniques drawn from child prevention and adult treatment models. Participating families (N=300) will be randomized to either FDP (12 weekly + 3 monthly sessions) or a written information comparison (WI) condition. All parents and children will be evaluated at pre- and post-intervention, and at 6-, 12-, 18-, and 24-months from baseline.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Depression

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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. Other Names: Cognitive behavioral intervention Coping skills training Parent training
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 Other Names: Psychoeducation Self-help

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	9 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Parent with a current or history of a depressive disorder within child's life
Children ages 9.0 to 15.6 years old

Exclusion Criteria:

Bipolar I (parent or child)
Schizophrenia (parent or child)
Current alcohol or drug abuse (parent or child)
Conduct disorder; developmental disability (child)
Current diagnosis of a depressive disorder (child)

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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United States, California
San Diego State University	Recruiting
San Diego, California, United States, 92120-4913
Contact: Robin Weersing, PhD 619-594-8892 robin.weersing@mail.sdsu.edu
Principal Investigator: Robin Weersing, PhD
United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37203-5721
Contact: Judy Garber, PhD 615-343-0595 jgarber.vanderbilt@gmail.com
Contact: Bruce Compas, PhD 615-322-8306 Bruce.Compas@Vanderbilt.edu
Principal Investigator: Judy Garber, PhD
Principal Investigator: Bruce Compas, PhD

Sponsors and Collaborators

Vanderbilt University

San Diego State University

Investigators

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Principal Investigator:	Judy Garber, PhD	Vanderbilt University
Principal Investigator:	Bruce Compas, PhD	Vanderbilt University
Principal Investigator:	Robin Weersing, PhD	San Diego State University

More Information

Publications:

Compas BE, Forehand R, Keller G, Champion JE, Rakow A, Reeslund KL, McKee L, Fear JM, Colletti CJ, Hardcastle E, Merchant MJ, Roberts L, Potts J, Garai E, Coffelt N, Roland E, Sterba SK, Cole DA. Randomized controlled trial of a family cognitive-behavioral preventive intervention for children of depressed parents. J Consult Clin Psychol. 2009 Dec;77(6):1007-20. doi: 10.1037/a0016930.

Compas BE, Champion JE, Forehand R, Cole DA, Reeslund KL, Fear J, Hardcastle EJ, Keller G, Rakow A, Garai E, Merchant MJ, Roberts L. Coping and parenting: Mediators of 12-month outcomes of a family group cognitive-behavioral preventive intervention with families of depressed parents. J Consult Clin Psychol. 2010 Oct;78(5):623-34. doi: 10.1037/a0020459.

Compas BE, Forehand R, Thigpen JC, Keller G, Hardcastle EJ, Cole DA, Potts J, Watson KH, Rakow A, Colletti C, Reeslund K, Fear J, Garai E, McKee L, Merchant MJ, Roberts L. Family group cognitive-behavioral preventive intervention for families of depressed parents: 18- and 24-month outcomes. J Consult Clin Psychol. 2011 Aug;79(4):488-99. doi: 10.1037/a0024254.

Garber J, Clarke GN, Weersing VR, Beardslee WR, Brent DA, Gladstone TR, DeBar LL, Lynch FL, D'Angelo E, Hollon SD, Shamseddeen W, Iyengar S. Prevention of depression in at-risk adolescents: a randomized controlled trial. JAMA. 2009 Jun 3;301(21):2215-24. doi: 10.1001/jama.2009.788.

Beardslee WR, Brent DA, Weersing VR, Clarke GN, Porta G, Hollon SD, Gladstone TR, Gallop R, Lynch FL, Iyengar S, DeBar L, Garber J. Prevention of depression in at-risk adolescents: longer-term effects. JAMA Psychiatry. 2013 Nov;70(11):1161-70. doi: 10.1001/jamapsychiatry.2013.295.

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Responsible Party:	Judith Garber, Professor, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT02021578 History of Changes
Other Study ID Numbers:	8482529
First Posted:	December 27, 2013 Key Record Dates
Last Update Posted:	May 20, 2019
Last Verified:	May 2019

Keywords provided by Judith Garber, Vanderbilt University:


Depression Mood disorder

Additional relevant MeSH terms:

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Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders

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