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A Family Depression Prevention Program

Family Cognitive Behavioral Prevention of Depression in Youth and Parents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02021578
Acronym
FDP
Enrollment
304
Registered
2013-12-27
Start date
2014-08-01
Completion date
2023-12-31
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, Mood disorder

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.

Interventions

BEHAVIORALFamily Cognitive Behavioral Prevention

Parent training and cognitive behavioral intervention with parents. Coping skills training with children.

Reading materials about depression

Sponsors

San Diego State University
CollaboratorOTHER
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Interviewers who assess diagnostic outcomes are masked to participant condition.

Eligibility

Sex/Gender
ALL
Age
9 Years to 15 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
In children, the primary outcome is level of symptoms on the Youth Self-report form.twelve months post baselineFor 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

MeasureTime frameDescription
In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child12 monthsFor 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)12 monthsParent participants: The PHQ-9 measures 9 symptoms of depression on a 4-point scale. Scores can range from 0 to 36.
Children: depressive diagnoses12 monthsChildren 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026