NCT02021578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

9.4 years

First QC Date

December 19, 2013

Last Update Submit

January 30, 2024

Conditions

Depression

Keywords

DepressionMood disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    12 months

  • Parents: Patient Health Questionnaire - 9 (PHQ-9)

    12 months

  • Children: depressive diagnoses

    12 months

Study Arms (2)

Family Cognitive Behavioral Prevention

EXPERIMENTAL

A family cognitive behavioral program for parents and children. Parents learn parenting skills and cognitive behavioral techniques for managing depression. Children learn coping skills.

Behavioral: Family Cognitive Behavioral Prevention

Written Information

ACTIVE COMPARATOR

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

Behavioral: Written information

Interventions

Family Cognitive Behavioral PreventionBEHAVIORAL

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

Also known as: Cognitive behavioral intervention, Coping skills training, Parent training
Family Cognitive Behavioral Prevention
Written informationBEHAVIORAL

Reading materials about depression

Also known as: Psychoeducation, Self-help
Written Information

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent with a current or history of a depressive disorder within child's life
  • Children ages 9- to 15-years-old

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Diego State University

San Diego, California, 92120-4913, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203-5721, United States

Location

Related 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.

    PMID: 37358525BACKGROUND

Related Links

MeSH Terms

Conditions

DepressionMood Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Judy Garber, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

  • Bruce Compas, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

  • Robin Weersing, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Interviewers who assess diagnostic outcomes are masked to participant condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 27, 2013

Study Start

August 1, 2014

Primary Completion

December 30, 2023

Study Completion

December 31, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data reported in publications will be made available to researchers upon request.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Data will be available after publication of results.
Access Criteria
Written requests for specific data, hypotheses, and data analytic plan

Locations

US(2)