Clinical Trial: Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions

Brief Summary: 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 traumatic brain injury and their families.

Detailed Summary: Traumatic brain injury (TBI) in adolescents is a significant stressor for both the teen and his or her family. Existing interventions are rare and access to treatment can be restricted by distance and finances. Based on previous findings and participant feedback, we propose to expand the previously developed TOPS intervention by conducting a multi-site study comparing the efficacy of TOPS to that of TOPS-Teen Only (TOPS-TO) in improving child behavior and functioning, parental depression and distress and family functioning. The efficacy of both active treatments would be examined in relation to an internet resource comparison group (IRC). During years 1-3, we will recruit 165 children between the ages of 11 and 18 with moderate to severe TBI and randomly assign them to receive TOPS, TOPS-TO, or IRC. We anticipate that TOPS will result in improvements in child, caregiver, and family functioning relative to IRC; but that TOPS-TO will only result in improvements in child behavior and adjustment. Based on prior research, we anticipate that the family-level treatment model of TOPS may be more effective than TOPS-TO in improving child behavior for children/adolescents with fewer social resources. Given these expectations, we will test the following hypotheses: 1) Children with TBI receiving either TOPS or TOPS-TO will have fewer behavior problems, greater social competence, and better functioning than those receiving IRC at both post-treatment and at a 6-month follow-up assessment. 2) Caregivers of children receiving TOPS will report less depression and psychological distress, less parent-child conflict, and better family functioning than those receiving TOPS-TO or IRC at both post-treatment and at a 6-month follow-up assessment. 3) Social resources will moderate treatment efficacy, such that children with limited social and economic resources will show greater improvements in the more comprehensive TOPS intervention. We hypothesize better teen problem solving and communi
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome: Parent Report Measures [ Time Frame: 5 years ]

Original Primary Outcome: Child behavior, social competence and general functioning [ Time Frame: Measured at follow up visit immediately after treatment then at 6 month post-treatment follow up visit ]

Current Secondary Outcome:

  • Teen Self-Report Measures [ Time Frame: 5 years ]
  • Neuropsychological Testing [ Time Frame: 5 years ]


Original Secondary Outcome:

  • Parent psychological distress [ Time Frame: Measured at follow up visit immediately after treatment then at 6 month post-treatment follow up visit ]
  • Family functioning [ Time Frame: Measured at follow up visit immediately after treatment then at 6 month post-treatment follow up visit ]
  • Parent-child conflict [ Time Frame: Measured at follow up visit immediately after treatment then at 6 month post-treatment follow up visit ]


Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: January 5, 2010
Date Started: March 2010
Date Completion:
Last Updated: March 7, 2016
Last Verified: March 2016