NCT00183482

Brief Summary

This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus educational treatment in preventing depression in the children of parents with a history of depression.

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

1 active site

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

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
8.9 years 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

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

9.4 years

First QC Date

September 13, 2005

Last Update Submit

January 14, 2024

Conditions

Depression

Keywords

ParentsChildStressCBT

Outcome Measures

Primary Outcomes (1)

  • Internalizing and Externalizing symptoms in children

    Child Behavior Checklist; Youth Self-Report; Internalizing and Externalizing Problems; Minimum T score = 40; Maximum T score = 80; Higher scores reflect worse outcome

    12 months

Secondary Outcomes (4)

  • Depressive symptoms in parents

    12 months

  • Coping skills of children

    12 months

  • Parenting skills of parents

    12 months

  • Onset of depressive disorders in children

    12 months

Study Arms (2)

Family Group Cognitive Behavioral

EXPERIMENTAL

The intervention is a family group cognitive behavioral program for families of parents with a history of depression to teach parenting skills to parents and coping skills to children.

Behavioral: Family Group Cognitive Behavioral

Written Information

ACTIVE COMPARATOR

The comparison arm involves providing written information about depression and stress to parents with a history of depression and their children.

Behavioral: Written Information

Interventions

Family Group Cognitive BehavioralBEHAVIORAL

Groups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions

Family Group Cognitive Behavioral
Written InformationBEHAVIORAL

Families are mailed written materials that describe depression and stress in families with a depressed parent.

Written Information

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Families with at least one parent with a history of depression during the life of his or her child
  • Families with at least one child between the age of 10 and 15
  • Parent or guardian willing to provide informed consent for participating children

You may not qualify if:

  • Parent with bipolar disorder or schizophrenia
  • Child with conduct disorder or pervasive developmental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • Ciriegio AE, Pine AE, Cole DA, McKee LG, Forehand R, Compas BE. Mediators of a randomized controlled trial of a preventive intervention for youth of parents with depressive disorders. J Consult Clin Psychol. 2025 Jan;93(1):1-13. doi: 10.1037/ccp0000928.

    PMID: 39786802DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Bruce E. Compas, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigators and outcome assessors are masked to condition of participants.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Repeated measures ANCOVA design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Patricia and Rodes Hart Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

August 1, 2014

Primary Completion

December 30, 2023

Study Completion

December 31, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations

US(1)