Clinical trial NCT02021578: A Family Depression Prevention Program
Official title: Family Cognitive Behavioral Prevention of Depression in Youth and Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Mood disorder
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: San Diego State University
First posted: 2013-12-27
Enrollment: 304
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: In children, the primary outcome is level of symptoms on the Youth Self-report form.
timeFrame: twelve months post baseline
Secondary outcomes:
measure: In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child
timeFrame: 12 months
measure: Parents: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 12 months
measure: Children: depressive diagnoses
timeFrame: 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Judy Garber, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Bruce Compas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Robin Weersing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.