Expired Study
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Pittsburgh, Pennsylvania 15637


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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Child between 5 and 17 years old who experienced a TBI in the past 12 months


Study is Available At:


Original ID:

0410002


NCT ID:

NCT00178022


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

5 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:


Overall Contact Information

Official Name:Armando J Rotondi, PhD
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:February 2005
Completion Date:September 2006
Completion Type:Actual
Verification Date:May 2008
Last Changed Date:May 27, 2008
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Previous investigations using problem solving therapy have documented large effect sizes on measures of problem solving and depression.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Similarly, the single previous controlled intervention following pediatric traumatic brain injury (TBI) demonstrated a large effect on self-report measures of depression and anxiety.
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Case management and problem solving therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh
Agency Class:Other
Agency Type:Collaborator
Agency Name:Children's Hospital Medical Center, Cincinnati

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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