Viewing Study NCT00409058



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Last Modification Date: 2024-10-26 @ 9:29 AM
Study NCT ID: NCT00409058
Status: COMPLETED
Last Update Posted: 2014-10-28
First Post: 2006-12-07

Brief Title: Teen Online Problem Solving TOPS - An Online Intervention Following TBI
Sponsor: Childrens Hospital Medical Center Cincinnati
Organization: Childrens Hospital Medical Center Cincinnati

Study Overview

Official Title: An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving TOPS
Status: COMPLETED
Status Verified Date: 2014-09
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: TOPS
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 andor 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 eg 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

Comparisons 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

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
Secondary IDs
Secondary ID Type Domain Link
H133G050239 OTHER_GRANT NIDRR None