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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.
Verified by National Institute of Mental Health (NIMH), March 2009
First Received: December 7, 2006   Last Updated: March 12, 2009   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00409448
  Purpose

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)

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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
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.
IRC: Active Comparator
Participants will receive the Internet resource comparison group treatment
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409448

Contacts
Contact: Kendra M. Williams, MA 513-636-1055 KendraM.Williams@cchmc.org

Locations
United States, Colorado
Denver Children's Hospital Recruiting
Denver, Colorado, United States, 80045
Contact: Robert Blaha, MA     720-777-5896     Blaha.Robert@tchden.org    
Principal Investigator: Michael W. Kirkwood, PhD            
United States, Minnesota
The Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Donna Felmlee-Devine, MS     507-284-6649     FelmleeDevine.Donna@mayo.edu    
Principal Investigator: Tanya Maines-Brown, PhD            
United States, Ohio
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Anne Slaven, MSSA     216-844-5541     ams87@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    
Principal Investigator: Shari L. Wade, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Shari L. Wade, PhD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Cincinnati Children's Hospital Medical Center ( Shari L. Wade, PhD )
Study ID Numbers: R01 MH073764, DDTR B2-NDA
Study First Received: December 7, 2006
Last Updated: March 12, 2009
ClinicalTrials.gov Identifier: NCT00409448     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
TBI
intracranial edema
brain edema
craniocerebral trauma
head injury
brain hemorrhage, traumatic
subdural hematoma
brain concussion
head injuries, closed
epidural hematoma
extra-axial hemorrhage
cortical contusion

Additional relevant MeSH terms:
Craniocerebral Trauma
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries

ClinicalTrials.gov processed this record on November 05, 2009