Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study (RRTC--TOPS)
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teen Online Problem Solving (TOPS)
Teen Online Problem Solving--Teen Only (TOPS-TO)
Internet Resources Comparison (IRC)
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- The Children's Hospital
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies' and Children's Hospital
- MetroHealth Medical Center
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Teen Online Problem Solving (TOPS)
Teen Online Problem Solving---Teen Only
Internet Resources Comparison
Arm Description
Web intervention
Web Intervention
Web Intervention
Outcomes
Primary Outcome Measures
Parent Report Measures
Secondary Outcome Measures
Teen Self-Report Measures
Neuropsychological Testing
Full Information
NCT ID
NCT01042899
First Posted
January 5, 2010
Last Updated
March 7, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
MetroHealth Medical Center, Nationwide Children's Hospital, Rainbow Babies and Children's Hospital, Children's Hospital Colorado
1. Study Identification
Unique Protocol Identification Number
NCT01042899
Brief Title
Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study
Acronym
RRTC--TOPS
Official Title
Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
MetroHealth Medical Center, Nationwide Children's Hospital, Rainbow Babies and Children's Hospital, Children's Hospital Colorado
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teen Online Problem Solving (TOPS)
Arm Type
Experimental
Arm Description
Web intervention
Arm Title
Teen Online Problem Solving---Teen Only
Arm Type
Experimental
Arm Description
Web Intervention
Arm Title
Internet Resources Comparison
Arm Type
Active Comparator
Arm Description
Web Intervention
Intervention Type
Behavioral
Intervention Name(s)
Teen Online Problem Solving (TOPS)
Other Intervention Name(s)
TOPS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teen Online Problem Solving--Teen Only (TOPS-TO)
Other Intervention Name(s)
TOPS-TO
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet Resources Comparison (IRC)
Other Intervention Name(s)
IRC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parent Report Measures
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Teen Self-Report Measures
Time Frame
5 years
Title
Neuropsychological Testing
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharil L Wade, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Rainbow Babies' and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35170571
Citation
Narad ME, Kaizar EE, Zhang N, Taylor HG, Yeates KO, Kurowski BG, Wade SL. The Impact of Preinjury and Secondary Attention-Deficit/Hyperactivity Disorder on Outcomes After Pediatric Traumatic Brain Injury. J Dev Behav Pediatr. 2022 Aug 1;43(6):e361-e369. doi: 10.1097/DBP.0000000000001067. Epub 2022 Feb 15.
Results Reference
derived
PubMed Identifier
31405391
Citation
Wade SL, Fisher AP, Kaizar EE, Yeates KO, Taylor HG, Zhang N. Recovery Trajectories of Child and Family Outcomes Following Online Family Problem-Solving Therapy for Children and Adolescents after Traumatic Brain Injury. J Int Neuropsychol Soc. 2019 Oct;25(9):941-949. doi: 10.1017/S1355617719000778. Epub 2019 Aug 13.
Results Reference
derived
PubMed Identifier
30738021
Citation
Narad ME, Raj S, Yeates KO, Taylor HG, Kirkwood MW, Stancin T, Wade SL. Randomized Controlled Trial of an Online Problem-Solving Intervention Following Adolescent Traumatic Brain Injury: Family Outcomes. Arch Phys Med Rehabil. 2019 May;100(5):811-820. doi: 10.1016/j.apmr.2019.01.010. Epub 2019 Feb 6.
Results Reference
derived
PubMed Identifier
30413559
Citation
Wade SL, Kaizar EE, Narad M, Zang H, Kurowski BG, Yeates KO, Taylor HG, Zhang N. Online Family Problem-solving Treatment for Pediatric Traumatic Brain Injury. Pediatrics. 2018 Dec;142(6):e20180422. doi: 10.1542/peds.2018-0422. Epub 2018 Nov 9.
Results Reference
derived
PubMed Identifier
29617953
Citation
Lantagne A, Peterson RL, Kirkwood MW, Taylor HG, Stancin T, Yeates KO, Wade SL. Featured Article: Interpersonal Stressors and Resources as Predictors of Adolescent Adjustment Following Traumatic Brain Injury. J Pediatr Psychol. 2018 Aug 1;43(7):703-712. doi: 10.1093/jpepsy/jsy020.
Results Reference
derived
PubMed Identifier
28836809
Citation
Wade SL, Narad ME, Kingery KM, Taylor HG, Stancin T, Kirkwood MW, Yeates KO. Teen online problem solving for teens with traumatic brain injury: Rationale, methods, and preliminary feasibility of a teen only intervention. Rehabil Psychol. 2017 Aug;62(3):290-299. doi: 10.1037/rep0000160.
Results Reference
derived
PubMed Identifier
28389109
Citation
Wade SL, Cassedy AE, Fulks LE, Taylor HG, Stancin T, Kirkwood MW, Yeates KO, Kurowski BG. Problem-Solving After Traumatic Brain Injury in Adolescence: Associations With Functional Outcomes. Arch Phys Med Rehabil. 2017 Aug;98(8):1614-1621. doi: 10.1016/j.apmr.2017.03.006. Epub 2017 Apr 4.
Results Reference
derived
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Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study
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