Traumatic Brain InjuryRRTC--TOPSNCT01042899
Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study
A study testing Teen Online Problem Solving (TOPS), Teen Online Problem Solving--Teen Only (TOPS-TO) and Internet Resources Comparison (IRC) in people with Traumatic Brain Injury, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Teen Online Problem Solving (TOPS), Teen Online Problem Solving--Teen Only (TOPS-TO) and Internet Resources Comparison (IRC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Moderate to severe TBI that occurred within the last 18 months
- Overnight hospital stay
- English-speaking
- Parent must be willing to provide informed consent
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45224
Rainbow Babies' and Children's Hospital
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Nationwide Children's Hospital
Columbus, Ohio, 43205
The Children's Hospital
Denver, Colorado, 80045
About this study
Official title: Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Teen Online Problem Solving (TOPS), Teen Online Problem Solving--Teen Only (TOPS-TO), Internet Resources Comparison (IRC)
- 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
- Medical subject headings
- Brain Injuries, Traumatic, Brain Edema, Craniocerebral Trauma, Brain Hemorrhage, Traumatic, Hematoma, Subdural, Brain Concussion, Head Injuries, Closed, Hematoma, Epidural, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen Online Problem Solving (TOPS)Behavioural
Also called 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.
Teen Online Problem Solving--Teen Only (TOPS-TO)Behavioural
Also called 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.
Internet Resources Comparison (IRC)Behavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Teen Online Problem Solving (TOPS) | Experimental | Web intervention Receives: Behavioral: Teen Online Problem Solving (TOPS); Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO); Behavioral: Internet Resources Comparison (IRC) |
| Teen Online Problem Solving---Teen Only | Experimental | Web Intervention Receives: Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO) |
| Internet Resources Comparison | Active comparator | Web Intervention Receives: Behavioral: Internet Resources Comparison (IRC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Report Measures
Measured: 5 years
Secondary outcomes (2)
Teen Self-Report Measures
Measured: 5 years
Neuropsychological Testing
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- MetroHealth Medical Center, Nationwide Children's Hospital, Rainbow Babies and Children's Hospital, Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Sharil L Wade, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042899
- Sponsor's protocol ID
- H133B090010--01
- Acronym
- RRTC--TOPS
- Status last verified
- Mar 2016
- First submitted
- 5 Jan 2010
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35170571Wade 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.
PubMed 31405391Narad 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.
PubMed 30738021Wade 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.
PubMed 30413559Lantagne 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.
PubMed 29617953Wade 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.
PubMed 28836809Wade 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.
PubMed 28389109
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions
- ClinicalTrials.gov ID
- NCT01042899
- Acronym / sponsor ID
- RRTC--TOPS / H133B090010--01
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, intracranial edema, brain edema, craniocerebral trauma, head injury, brain hemorrhage, traumatic, subdural hematoma, brain concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- MetroHealth Medical Center, Nationwide Children's Hospital, Rainbow Babies and Children's Hospital, Children's Hospital Colorado
- Study start
- Mar 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Teen Online Problem Solving (TOPS) | Experimental | Behavioral: Teen Online Problem Solving (TOPS), Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO), Behavioral: Internet Resources Comparison (IRC)Web intervention |
| Teen Online Problem Solving---Teen Only | Experimental | Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO)Web Intervention |
| Internet Resources Comparison | Active comparator | Behavioral: Internet Resources Comparison (IRC)Web Intervention |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Moderate to severe TBI that occurred within the last 18 months
- Overnight hospital stay
- English-speaking
- Parent must be willing to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teen Online Problem Solving (TOPS)Also: TOPSThe 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. | Behavioural | Teen Online Problem Solving (TOPS) |
| Teen Online Problem Solving--Teen Only (TOPS-TO)Also: TOPS-TOTOPS-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. | Behavioural | Teen Online Problem Solving (TOPS), Teen Online Problem Solving---Teen Only |
| Internet Resources Comparison (IRC)Also: IRCFamilies 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. | Behavioural | Internet Resources Comparison, Teen Online Problem Solving (TOPS) |
Primary outcome
Parent Report Measures
Time frame: 5 years
2 secondary outcomes
Teen Self-Report Measures
Time frame: 5 years
Neuropsychological Testing
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Derived from this study: PubMed 35170571Narad 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.
- Derived from this study: PubMed 31405391Wade 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.
- Derived from this study: PubMed 30738021Narad 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.
- Derived from this study: PubMed 30413559Wade 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.
- Derived from this study: PubMed 29617953Lantagne 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.
- Derived from this study: PubMed 28836809Wade 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.
- Derived from this study: PubMed 28389109Wade 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharil L Wade, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teen Online Problem Solving (TOPS), Teen Online Problem Solving--Teen Only (TOPS-TO) and Internet Resources Comparison (IRC) in people with Traumatic Brain Injury, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Report Measures (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01042899, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.