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Internet-Based Treatment for Children With Traumatic Brain Injuries & Their Families: Counselor Assisted Problem Solving (CAPS)
This study is currently recruiting participants.
Study NCT00409448   Information provided by National Institute of Mental Health (NIMH)
First Received: December 7, 2006   Last Updated: March 12, 2009   History of Changes

December 7, 2006
March 12, 2009
March 2007
January 2011   (final data collection date for primary outcome measure)
  • Problem-solving skills [ Time Frame: Measured immediately after treatment and at Months 6 and 12 follow-ups ] [ Designated as safety issue: No ]
  • Parent-child communication [ Time Frame: Measured immediately after treatment and at Months 6 and 12 follow-ups ] [ Designated as safety issue: No ]
  • Problem Solving Discussion Rating
  • FAD GF, PS, Communication Scales
  • Iowa Family Interaction Rating Scale
Complete list of historical versions of study NCT00409448 on ClinicalTrials.gov Archive Site
  • Child functioning [ Time Frame: Measured immediately after treatment and at Months 6 and 12 follow-ups ] [ Designated as safety issue: No ]
  • Behavior problems [ Time Frame: Measured immediately after treatment and at Months 6 and 12 follow-ups ] [ Designated as safety issue: No ]
  • Parent psychological distress [ Time Frame: Measured immediately after treatment and at Months 6 and 12 follow-ups ] [ Designated as safety issue: No ]
  • Parent
  • SCL-90-R
  • CES-D
  • Child
  • CAFAS
  • CBCL
  • BRIEF
  • HCSBS
 
Internet-Based Treatment for Children With Traumatic Brain Injuries & Their Families: Counselor Assisted Problem Solving
Improving Mental Health Outcomes of Child Brain Injury

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.

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.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Traumatic Brain Injury
  • Behavioral: Counselor-assisted problem solving (CAPS)
  • Behavioral: Internet-resource comparison (IRC)
  • Experimental: Participants will receive the Internet-based counselor-assisted problem-solving group treatment
  • Active Comparator: Participants will receive the Internet resource comparison group treatment
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate to severe TBI that occurred within the last 6 months
  • Overnight hospital stay
  • English-speaking
  • Parent must be willing to provide informed consent

Exclusion Criteria:

  • Child does not live with parents or guardian
  • Child or parent has history of hospitalization for psychiatric problem
  • TBI is a result of child abuse
  • Child suffered a nonblunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)
  • Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability
Both
12 Years to 17 Years
No
Contact: Kendra M. Williams, MA 513-636-1055 KendraM.Williams@cchmc.org
United States
 
NCT00409448
Shari L. Wade, PhD, Cincinnati Children's Hospital Medical Center
R01 MH073764, DDTR B2-NDA
National Institute of Mental Health (NIMH)
 
Principal Investigator: Shari L. Wade, PhD Children's Hospital Medical Center, Cincinnati
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP