NCT00061698

Brief Summary

This study will compare the effectiveness of three therapies for the treatment of depression in preadolescent girls.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for phase_1 depression

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_1 depression

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

Study Start

First participant enrolled

April 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2003

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

6.3 years

First QC Date

June 3, 2003

Last Update Submit

June 11, 2015

Conditions

Study Arms (3)

Cognitive Behavior Therapy Child Only

ACTIVE COMPARATOR

Participants completed 20 sessions of CBT

Behavioral: Cognitive Behavior Therapy Child Only

CBT plus Parent training

ACTIVE COMPARATOR

Child participants completed 20 sessions of CBT and parents completed 8 sessions of parent training

Behavioral: Cognitive Behavior Therapy Child OnlyBehavioral: CBT plus Parent Training

Minimal Contact Control

NO INTERVENTION

Participants waited 12 weeks for treatment but their safety and well-being were monitored during this time

Interventions

Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.

CBT plus Parent trainingCognitive Behavior Therapy Child Only

Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief. Parents learned skills that helped their child to apply the strategies they learned. Parents learned how to better communicate positive information that helped their child build a positive core belief. Parents learned how to use reinforcement to support healthy behavior.

CBT plus Parent training

Eligibility Criteria

Age9 Years - 13 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Depressive Disorder

You may not qualify if:

  • Learning disability or limited intellectual ability
  • Health-related illness that would prevent the patient from completing the research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Cole DA, Cai L, Martin NC, Findling RL, Youngstrom EA, Garber J, Curry JF, Hyde JS, Essex MJ, Compas BE, Goodyer IM, Rohde P, Stark KD, Slattery MJ, Forehand R. Structure and measurement of depression in youths: applying item response theory to clinical data. Psychol Assess. 2011 Dec;23(4):819-33. doi: 10.1037/a0023518. Epub 2011 May 2.

    PMID: 21534696BACKGROUND
  • Stark, K. D. (2008). Experiences Implementing the ACTION Treatment Program: Implications for Preventive Interventions. Clinical Psychology: Science and Practice, 15, 342 - 345.

    BACKGROUND
  • Stapleton LM, Sander JB, Stark KD. Psychometric properties of the Beck Depression Inventory for Youth in a sample of girls. Psychol Assess. 2007 Jun;19(2):230-5. doi: 10.1037/1040-3590.19.2.230.

    PMID: 17563204BACKGROUND
  • Morey, M. E., Arora, P., & Stark, K. D. (in press). Multiple-Stage Screening of Youth Depression in Schools. Psychology in the Schools.

    RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2003

First Posted

June 4, 2003

Study Start

April 1, 2002

Primary Completion

August 1, 2008

Study Completion

December 1, 2008

Last Updated

June 12, 2015

Record last verified: 2015-06