Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01042899
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2010-01-05
Brief Title:
Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RRTC--TOPS
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 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 childrenadolescents 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 emotionalbehavioral 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 teens social and emotional functioning thereby enabling him or her to better negotiate the complex transition to adulthood and independent functioning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None