A Family Depression Prevention Program (FDP)
Primary Purpose
Depression
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Cognitive Behavioral Prevention
Written information
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Depression, Mood disorder
Eligibility Criteria
Inclusion Criteria:
- Parent with a current or history of a depressive disorder within child's life
- Children ages 9- to 15-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)
Sites / Locations
- San Diego State University
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Family Cognitive Behavioral Prevention
Written Information
Arm Description
A family cognitive behavioral program for parents and children. Parents learn parenting skills and cognitive behavioral techniques for managing depression. Children learn coping skills.
Families receive written materials about depression and the effects of parental depression on children.
Outcomes
Primary Outcome Measures
In children, the primary outcome is level of symptoms on the Youth Self-report form.
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).
Secondary Outcome Measures
In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child
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)
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
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.
Full Information
NCT ID
NCT02021578
First Posted
December 19, 2013
Last Updated
January 7, 2023
Sponsor
Vanderbilt University
Collaborators
San Diego State University
1. Study Identification
Unique Protocol Identification Number
NCT02021578
Brief Title
A Family Depression Prevention Program
Acronym
FDP
Official Title
Family Cognitive Behavioral Prevention of Depression in Youth and Parents
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
San Diego State University
4. Oversight
Data Monitoring Committee
Yes
5. 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 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.
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 (10 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-months from baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Mood disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Interviewers who assess diagnostic outcomes are masked to participant condition.
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Family Cognitive Behavioral Prevention
Arm Type
Experimental
Arm Description
A family cognitive behavioral program for parents and children. Parents learn parenting skills and cognitive behavioral techniques for managing depression. Children learn coping skills.
Arm Title
Written Information
Arm Type
Active Comparator
Arm Description
Families receive written materials about depression and the effects of parental depression on children.
Intervention Type
Behavioral
Intervention Name(s)
Family Cognitive Behavioral Prevention
Other Intervention Name(s)
Cognitive behavioral intervention, Coping skills training, Parent training
Intervention Description
Parent training and cognitive behavioral intervention with parents. Coping skills training with children.
Intervention Type
Behavioral
Intervention Name(s)
Written information
Other Intervention Name(s)
Psychoeducation, Self-help
Intervention Description
Reading materials about depression
Primary Outcome Measure Information:
Title
In children, the primary outcome is level of symptoms on the Youth Self-report form.
Description
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).
Time Frame
twelve months post baseline
Secondary Outcome Measure Information:
Title
In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child
Description
For child participants, we will assess change in their levels of symptoms on the Child Behavior checklist at 12-month follow-up.
Time Frame
12 months
Title
Parents: Patient Health Questionnaire - 9 (PHQ-9)
Description
Parent participants: The PHQ-9 measures 9 symptoms of depression on a 4-point scale. Scores can range from 0 to 36.
Time Frame
12 months
Title
Children: depressive diagnoses
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parent with a current or history of a depressive disorder within child's life
Children ages 9- to 15-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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Garber, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Compas, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robin Weersing, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92120-4913
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-5721
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data reported in publications will be made available to researchers upon request.
IPD Sharing Time Frame
Data will be available after publication of results.
IPD Sharing Access Criteria
Written requests for specific data, hypotheses, and data analytic plan
Citations:
PubMed Identifier
19968378
Citation
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.
Results Reference
background
PubMed Identifier
20873898
Citation
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.
Results Reference
background
PubMed Identifier
21707137
Citation
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.
Results Reference
background
PubMed Identifier
19491183
Citation
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.
Results Reference
background
PubMed Identifier
24005242
Citation
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.
Results Reference
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A Family Depression Prevention Program
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