Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409448
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2006-12-07
Brief Title:
Internet-Based Treatment for Children With Traumatic Brain Injuries Their Families Counselor Assisted Problem Solving
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Improving Mental Health Outcomes of Child Brain Injury
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:
CAPS
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 children who have had a traumatic brain injury and their families
Detailed Description:
A traumatic brain injury TBI is caused by a strong blow jolt or penetration to the head that disrupts normal brain functioning A TBI can range from a mild concussion to severe brain damage Falls assaults and motor vehicle accidents account for more than 50 of TBIs Physical symptoms of a TBI can be subtle to severe and can include nausea memory loss mood swings blurred vision and light-headedness This type of injury can be very stressful for families and can result in feelings of anxiety burden and depression among family members A child who experiences a TBI will often display new social and behavioral problems leading to further parental distress and increased family dysfunction Recent studies have shown that problem-solving interventions can reduce caregiver distress and improve child adjustment following a TBI However access to skilled therapists and specialized care for this kind of psychosocial treatment is often limited in many communities In such communities the Internet offers a new way to meet the mental and other health needs of individuals with TBIs 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 TBI and their families
Families participating in this study will be randomly assigned to either an Internet-based counselor-assisted problem-solving CAPS group or an Internet resource comparison group IRC Participants assigned to CAPS will work with a trained counselor who will guide them through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions Families assigned to IRC will receive computers high speed Internet access and links to brain injury information and resources but no access to the CAPS Web site content The effectiveness of CAPS will be assessed after treatment and at 6- and 12-month follow-up evaluations
Families participating in this study will be randomly assigned to either an Internet-based counselor-assisted problem-solving CAPS group or an Internet resource comparison group IRC Participants assigned to CAPS will work with a trained counselor who will guide them through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions Families assigned to IRC will receive computers high speed Internet access and links to brain injury information and resources but no access to the CAPS Web site content The effectiveness of CAPS will be assessed after treatment and at 6- and 12-month follow-up evaluations
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 |
|---|---|---|---|
| DDTR B2-NDA | None | None | None |