A Family Depression Prevention Program

Depression Clinical Trial

— FDP  

Official title:

Family Cognitive Behavioral Prevention of Depression in Youth and Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021578
• Other study ID #: 8482529
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Family Cognitive Behavioral Prevention
Parent training and cognitive behavioral intervention with parents. Coping skills training with children.
• Written information
Reading materials about depression

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee
United States	San Diego State University	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	San Diego State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kado-Walton M, Vreeland A, Henry L, Gruhn M, Compas B, Garber J, Weersing VR. Racial/ethnic differences in parenting behaviors among depressed parents. J Fam Psychol. 2023 Sep;37(6):763-773. doi: 10.1037/fam0001125. Epub 2023 Jun 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	twelve months post baseline
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months

External Links

•   Link to PMC10613481