A Family Depression Prevention Program (FDP)

Vanderbilt University

Status: Completed

Conditions: Depression

Treatments: Behavioral: Family Cognitive Behavioral Prevention; Behavioral: Written information

Study type: Interventional

Funder types: Other

Identifiers

NCT02021578

8482529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 9 to 15 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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304 participants in 2 patient groups

Family Cognitive Behavioral Prevention

Experimental group

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.

Treatment:

Behavioral: Family Cognitive Behavioral Prevention

Written Information

Active Comparator group

Description:

Families receive written materials about depression and the effects of parental depression on children.

Treatment:

Behavioral: Written information