Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study (RRTC--TOPS)
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ClinicalTrials.gov Identifier: NCT01042899 |
Recruitment Status
:
Completed
First Posted
: January 6, 2010
Last Update Posted
: March 8, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Traumatic Brain Injury | Behavioral: Teen Online Problem Solving (TOPS) Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO) Behavioral: Internet Resources Comparison (IRC) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 153 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Teen Online Problem Solving (TOPS)
Web intervention
|
Behavioral: Teen Online Problem Solving (TOPS)
The TOPS program has 10 sessions that provide training in stress management, problem solving, communication, and social skills to all enrolled families, while the remaining 6 sessions address content related to the stressors and burdens of individual families. Each self-guided online session includes real adolescents talking about how TBI affected them, content regarding the skill, video clips showing adolescents and/or families modeling the skill, and exercises giving the family an opportunity to practice the skill. After the completion of the self-guided web pages, the family will meet with the therapist via videoconference; the therapist will review the exercises and help the family implement the problem-solving process with a problem or goal identified by the family.
Other Name: TOPS
Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO)
TOPS-TO targets the same skills as TOPS and includes largely the same website and intervention content. However, it differs with respect to the extent of family involvement in the sessions. In TOPS-TO, sessions will be conducted with the child or adolescent alone, rather than with the family as whole. Parents will be given access to the TOPS-TO website content via their own password protected site so they will understand the skills that their child is learning. However, only the adolescent, and not the parents, will participate in the synchronous videoconferences with the therapist.
Other Name: TOPS-TO
Behavioral: Internet Resources Comparison (IRC)
Families in the IRC group will also receive a computer, printer, and high-speed internet access if they do not currently have these. Additionally, IRC families receive access to a home page of brain injury resources and links (identical to those given on the TOPS and TOPS-TO homepage) but will not be able to access specific session content. This will enable us to equate the groups with respect to access to the information and resources available on the Web.
Other Name: IRC
|
Experimental: Teen Online Problem Solving---Teen Only
Web Intervention
|
Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO)
TOPS-TO targets the same skills as TOPS and includes largely the same website and intervention content. However, it differs with respect to the extent of family involvement in the sessions. In TOPS-TO, sessions will be conducted with the child or adolescent alone, rather than with the family as whole. Parents will be given access to the TOPS-TO website content via their own password protected site so they will understand the skills that their child is learning. However, only the adolescent, and not the parents, will participate in the synchronous videoconferences with the therapist.
Other Name: TOPS-TO
|
Active Comparator: Internet Resources Comparison
Web Intervention
|
Behavioral: Internet Resources Comparison (IRC)
Families in the IRC group will also receive a computer, printer, and high-speed internet access if they do not currently have these. Additionally, IRC families receive access to a home page of brain injury resources and links (identical to those given on the TOPS and TOPS-TO homepage) but will not be able to access specific session content. This will enable us to equate the groups with respect to access to the information and resources available on the Web.
Other Name: IRC
|
- Parent Report Measures [ Time Frame: 5 years ]
- Teen Self-Report Measures [ Time Frame: 5 years ]
- Neuropsychological Testing [ Time Frame: 5 years ]

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Ages Eligible for Study: | 11 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Moderate to severe TBI that occurred within the last 18 months
- Overnight hospital stay
- English-speaking
- Parent must be willing to provide informed consent
Exclusion Criteria:
- Child does not live with parents or guardian
- Child or parent has history of hospitalization for psychiatric problem
- TBI is a result of child abuse
- Child suffered a non-blunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)
- Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042899
United States, Colorado | |
The Children's Hospital | |
Denver, Colorado, United States, 80045 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45224 | |
Rainbow Babies' and Children's Hospital | |
Cleveland, Ohio, United States, 44106 | |
MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109 | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 |
Principal Investigator: | Sharil L Wade, PhD | Children's Hospital Medical Center, Cincinnati |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT01042899 History of Changes |
Other Study ID Numbers: |
H133B090010--01 |
First Posted: | January 6, 2010 Key Record Dates |
Last Update Posted: | March 8, 2016 |
Last Verified: | March 2016 |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
TBI intracranial edema brain edema craniocerebral trauma head injury brain hemorrhage, traumatic subdural hematoma brain concussion |
head injuries, closed epidural hematoma extra-axial hemorrhage cortical contusion wounds and injuries disorders of environmental origin trauma, nervous system brain injuries |
Additional relevant MeSH terms:
Wounds and Injuries Brain Injuries Brain Injuries, Traumatic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |