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A Trial of Two On-Line Interventions for Child Brain Injury

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Centers for Disease Control and Prevention
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00178022
First received: September 13, 2005
Last updated: May 27, 2008
Last verified: May 2008
History of Changes
  Purpose

The primary aims of this project are to examine the feasibility and relative efficacy of two models of on-line intervention for families of children with traumatic brain injury: one, a model emphasizing cognitive appraisals and problem solving skills; the other, emphasizing linking families to resources and providing professionally-moderated peer support.


Condition Intervention
Traumatic Brain Injury
Depression
Anxiety Disorders
 Behavioral: Case management and problem solving therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Official Title: A Trial of Two On-Line Interventions for Child Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Previous investigations using problem solving therapy have documented large effect sizes on measures of problem solving and depression.

Secondary Outcome Measures:
  • Similarly, the single previous controlled intervention following pediatric traumatic brain injury (TBI) demonstrated a large effect on self-report measures of depression and anxiety.

Estimated Enrollment: 120
Study Start Date: February 2005
Study Completion Date: September 2006
Detailed Description:

The feasibility of the two interventions will be evaluated by examining family utilization of on-line materials and satisfaction with receiving services this way. Previous studies suggest the longer-term effects of TBI often create significant stress for both child and family and the need for psychological services.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Child between 5 and 17 years old who experienced a TBI in the past 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178022

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15637
Sponsors and Collaborators
University of Pittsburgh
Children's Hospital Medical Center, Cincinnati
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Armando J Rotondi, PhD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00178022     History of Changes
Other Study ID Numbers: 0410002
Study First Received: September 13, 2005
Last Updated: May 27, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
tbi
intervention
depression
anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Brain Injuries
Mental Disorders
Behavioral Symptoms
Mood Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013