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Clinical Trials/NCT00409058
NCT00409058
Completed
N/A

An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving (TOPS)

Children's Hospital Medical Center, Cincinnati2 sites in 1 country42 target enrollmentOctober 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
TBI (Traumatic Brain Injury)
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
42
Locations
2
Primary Endpoint
Parent Report Measures
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to learn if using the World Wide Web to train teens and their families in problem-solving, communication skills, and stress management strategies can help them to cope better following traumatic brain injury (TBI). To answer this question, we will look at changes from before the intervention to after the intervention on questionnaire measures of problem-solving skills, communication, social competence, adjustment, and family stress and burden. We hypothesize that families receiving the TOPS intervention will have better parent-child communication and problem-solving skills at follow-up than those receiving the IRC intervention. Additionally, families receiving the TOPS intervention will have lower levels of parental distress, fewer child behavior problems and better child functioning than those receiving the IRC intervention. Lastly, treatment effects will be moderated by SES and life stresses, such that families with greater social disadvantage will benefit more from the TOPS intervention.

Detailed Description

Traumatic Brain Injury (TBI) creates significant stress for families resulting in increased burden, anxiety and depression among family members. Both pre- and post-injury family functioning have been linked to child outcomes, suggesting that improvements in family adaptation may result in fewer social and behavioral sequelae in the injured child. Despite this evidence, the development and evaluation of family interventions following TBI are extremely rare. Children with TBI are often treated at urban trauma centers then discharged to distant home communities where psychosocial follow-up is limited and/or difficult to access. Increasingly, the World Wide Web is being used to meet the mental and other health needs of individuals who have difficulty accessing care through traditional routes. Given the lack of specialized care and follow-up for TBI in many communities, the Web may provide an invaluable tool for linking families with state-of-the-art psychosocial care by reducing potential physical and psychological barriers (e.g., distance, stigma). Building on previous intervention research of the PI, this study targets the adolescent population between the ages of 12-18. By identifying the unique concerns and issues of this population following brain injury, Teen Online Problem Solving seeks to improve family and teen adaptation, thereby reducing social and behavioral sequelae. Comparison(s): Teen Online Problem Solving (TOPS) intervention with online curriculum and sequential videoconference therapy sessions in addition to usual care, compared to Internet Resource Comparison with online access to resources in addition to usual care.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
December 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • between 11 and 18 years of age
  • moderate to severe traumatic brain injury
  • overnight hospital stay
  • injury occurred within the last 12 months

Exclusion Criteria

  • younger than 11 and older than 18 years of age
  • injury occurred more than 12 months ago
  • teen does not live with parents or guardian
  • English not spoken in the home
  • injury is a result of child abuse as documented by medical record
  • child or parent has history of hospitalization for a psychiatric problem
  • documentation that the injury is a result of child abuse
  • child suffered a non-blunt injury (e.g. projectile wounds, stroke, drowning, or other form of asphyxiation)
  • child ever diagnosed with moderate or severe mental retardation, Autism, or a significant developmental disability (child must be able to talk)
  • plans for the child to leave home during the coming 12 months.

Outcomes

Primary Outcomes

Parent Report Measures

Time Frame: 4 years

Secondary Outcomes

  • Teen Self-Report Measures(4 years)

Study Sites (2)

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