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

Sponsors and Collaborators:	University of Pittsburgh Children's Hospital Medical Center, Cincinnati Centers for Disease Control and Prevention
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00178022

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

MedlinePlus related topics: Anxiety Depression Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study
Official Title:	A Trial of Two On-Line Interventions for Child Brain Injury

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

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

Keywords provided by University of Pittsburgh:

tbi
intervention
depression
anxiety

Study placed in the following topic categories:

Craniocerebral Trauma
Depression
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Depressive Disorder

Brain Diseases
Behavioral Symptoms
Anxiety Disorders
Mental Disorders
Mood Disorders
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009