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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178022
• Other study ID #: 0410002
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: May 27, 2008
• Start date: February 2005
• Est. completion date: September 2006

Study information

• Verified date: May 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• Child between 5 and 17 years old who experienced a TBI in the past 12 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Anxiety Disorders
• Brain Injuries
• Depression
• Traumatic Brain Injury

Intervention

Behavioral:
• Case management and problem solving therapy

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Centers for Disease Control and Prevention, Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

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