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Sponsored by: |
National Institute of Mental Health (NIMH) |
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00409448 |
This study will evaluate the effectiveness of an Internet-based psychosocial treatment in improving problem-solving, communication skills, stress management strategies, and coping among children who have had a traumatic brain injury and their families.
Condition | Intervention |
Traumatic Brain Injury |
Behavioral: Counselor-assisted problem solving (CAPS) Behavioral: Internet-resource comparison (IRC) |
MedlinePlus related topics: | Child Mental Health Head and Brain Injuries Mental Health |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Improving Mental Health Outcomes of Child Brain Injury |
Estimated Enrollment: | 120 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
CAPS: Experimental
Participants will receive the Internet-based counselor-assisted problem-solving group treatment
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Behavioral: Counselor-assisted problem solving (CAPS)
In CAPS, a trained counselor will guide families through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions.
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IRC: Active Comparator
Participants will receive the Internet resource comparison group treatment
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Behavioral: Internet-resource comparison (IRC)
Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources, but not the CAPS website content.
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A traumatic brain injury (TBI) is caused by a strong blow, jolt, or penetration to the head that disrupts normal brain functioning. A TBI can range from a mild concussion to severe brain damage. Falls, assaults, and motor vehicle accidents account for more than 50% of TBIs. Physical symptoms of a TBI can be subtle to severe and can include nausea, memory loss, mood swings, blurred vision, and light-headedness. This type of injury can be very stressful for families and can result in feelings of anxiety, burden, and depression among family members. A child who experiences a TBI will often display new social and behavioral problems, leading to further parental distress and increased family dysfunction. Recent studies have shown that problem-solving interventions can reduce caregiver distress and improve child adjustment following a TBI. However, access to skilled therapists and specialized care for this kind of psychosocial treatment is often limited in many communities. In such communities, the Internet offers a new way to meet the mental and other health needs of individuals with TBIs. This study will evaluate the effectiveness of an Internet-based psychosocial treatment in improving problem solving, communication skills, stress management strategies, and coping among teens who have had a TBI and their families.
Families participating in this study will be randomly assigned to either an Internet-based counselor-assisted problem-solving (CAPS) group or an Internet resource comparison group (IRC). Participants assigned to CAPS will work with a trained counselor who will guide them through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions. Families assigned to IRC will receive computers, high speed Internet access, and links to brain injury information and resources, but no access to the CAPS Web site content. The effectiveness of CAPS will be assessed after treatment and at 6- and 12-month follow-up evaluations.
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kendra M. Williams, MA | 513-636-1055 | KendraM.Williams@cchmc.org |
United States, Ohio | |||||
Rainbow Babies and Children's Hospital | Recruiting | ||||
Cleveland, Ohio, United States, 44106 | |||||
Contact: Beth Hagesfeld, MA 216-844-6294 beth.hagesfeld@case.edu | |||||
Principal Investigator: Hudson G. Taylor, PhD | |||||
MetroHealth Medical Center | Recruiting | ||||
Cleveland, Ohio, United States, 44106 | |||||
Contact: Britt Nielsen, PsyD 216-778-3745 bnielsen@metrohealth.org | |||||
Sub-Investigator: Terry Stancin, PhD | |||||
Cincinnati Children's Hospital | Recruiting | ||||
Cincinnati, Ohio, United States, 45229 | |||||
Contact: Kendra M. Williams, MA 513-636-1055 KendraM.Williams@cchmc.org | |||||
Contact: Samantha | |||||
Principal Investigator: Shari L. Wade, PhD |
Principal Investigator: | Shari L. Wade, PhD | Children's Hospital Medical Center, Cincinnati |
Responsible Party: | Cincinnati Children's Hospital Medical Center ( Shari L. Wade, PhD ) |
Study ID Numbers: | R01 MH073764, DDTR B2-NDA |
First Received: | December 7, 2006 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00409448 |
Health Authority: | United States: Federal Government |
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