Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study (RRTC--TOPS)
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| First Received Date ICMJE | January 5, 2010 | ||||
| Last Updated Date | June 12, 2012 | ||||
| Start Date ICMJE | March 2010 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01042899 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | 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 communication skills, fewer teen emotional/behavioral problems, less parental burden and distress, and less parent-teen conflict at follow-up among the TOPS group compared to the IRC group. TOPS makes use of emerging technology to address the multifaceted needs of teens following TBI with the goal of improving the teen's social and emotional functioning, thereby enabling him or her to better negotiate the complex transition to adulthood and independent functioning. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Traumatic Brain Injury | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 165 | ||||
| Estimated Completion Date | October 2015 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 11 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01042899 | ||||
| Other Study ID Numbers ICMJE | H133B090010--01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Children's Hospital Medical Center, Cincinnati | ||||
| Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Children's Hospital Medical Center, Cincinnati | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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