Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study
RRTC--TOPS
1 other identifier
interventional
153
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2010
CompletedFirst Posted
Study publicly available on registry
January 6, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 8, 2016
March 1, 2016
5.8 years
January 5, 2010
March 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parent Report Measures
5 years
Secondary Outcomes (2)
Teen Self-Report Measures
5 years
Neuropsychological Testing
5 years
Study Arms (3)
Teen Online Problem Solving (TOPS)
EXPERIMENTALWeb intervention
Teen Online Problem Solving---Teen Only
EXPERIMENTALWeb Intervention
Internet Resources Comparison
ACTIVE COMPARATORWeb Intervention
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Moderate to severe TBI that occurred within the last 18 months
- Overnight hospital stay
- English-speaking
- Parent must be willing to provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Medical Center, Cincinnatilead
- MetroHealth Medical Centercollaborator
- Nationwide Children's Hospitalcollaborator
- Rainbow Babies and Children's Hospitalcollaborator
- Children's Hospital Coloradocollaborator
Study Sites (5)
The Children's Hospital
Denver, Colorado, 80045, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45224, United States
Rainbow Babies' and Children's Hospital
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Related Publications (7)
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.
PMID: 35170571DERIVEDWade 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.
PMID: 31405391DERIVEDNarad 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.
PMID: 30738021DERIVEDWade 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.
PMID: 30413559DERIVEDLantagne 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.
PMID: 29617953DERIVEDWade 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.
PMID: 28836809DERIVEDWade 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.
PMID: 28389109DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharil L Wade, PhD
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2010
First Posted
January 6, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 8, 2016
Record last verified: 2016-03