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Completed

NCT Number: NCT02021578

A Family Depression Prevention Program

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Mental Disorders Mood Disorders

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Family Cognitive Behavioral Prevention

Behavioral

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

Other names: Cognitive behavioral intervention, Coping skills training, Parent training

Written Information

Behavioral

Reading materials about depression

Other names: Psychoeducation, Self-help

Primary outcomes

  1. In children, the primary outcome is level of symptoms on the Youth Self-report form.

    Time frame: twelve months post baseline

    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 outcomes

  1. In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child

    Time frame: 12 months

    For child participants, we will assess change in their levels of symptoms on the Child Behavior checklist at 12-month follow-up.

  2. Parents: Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: 12 months

    Parent participants: The PHQ-9 measures 9 symptoms of depression on a 4-point scale. Scores can range from 0 to 36.

  3. Children: depressive diagnoses

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • San Diego State University

Registry information

Official study title

Family Cognitive Behavioral Prevention of Depression in Youth and Parents

Acronym: FDP

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2013
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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