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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), September 2008

Sponsored by: 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)

MedlinePlus related topics:   Child Mental Health    Head and Brain Injuries    Mental Health   

U.S. FDA Resources

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

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, 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            

Sponsors and Collaborators

Investigators
Principal Investigator:     Shari L. Wade, PhD     Children's Hospital Medical Center, Cincinnati    
  More Information


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

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

Study placed in the following topic categories:
Craniocerebral Trauma
Wounds and Injuries
Disorders of Environmental Origin
Head Injuries, Closed
Edema
Central Nervous System Diseases
Brain Edema
Trauma, Nervous System
Hemorrhage
Brain Diseases
Brain Concussion
Hematoma
Contusions
Brain Injuries

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 22, 2008




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