TBI (Traumatic Brain Injury)TOPSNCT00409058
Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI
A study testing Teen Online Problem Solving in people with TBI (Traumatic Brain Injury) and Brain Edema, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial summary
The purpose of this study is to learn if using the World Wide Web to train teens and their families in problem-solving, communication skills, and stress management strategies can help them to cope better following traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- TBI (Traumatic Brain Injury), Brain Edema, Craniocerebral Trauma
- What is being tested?
- Teen Online Problem Solving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Dec 2009
- 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
- between 11 and 18 years of age
- moderate to severe traumatic brain injury
- overnight hospital stay
- injury occurred within the last 12 months
Who cannot join
- younger than 11 and older than 18 years of age
- injury occurred more than 12 months ago
- teen does not live with parents or guardian
- English not spoken in the home
- injury is a result of child abuse as documented by medical record
- child or parent has history of hospitalization for a psychiatric problem
Show all 10Show fewer
- documentation that the injury is a result of child abuse
- child suffered a non-blunt injury (e.g. projectile wounds, stroke, drowning, or other form of asphyxiation)
- child ever diagnosed with moderate or severe mental retardation, Autism, or a significant developmental disability (child must be able to talk)
- plans for the child to leave home during the coming 12 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving (TOPS)
The purpose of this study is to learn if using the World Wide Web to train teens and their families in problem-solving, communication skills, and stress management strategies can help them to cope better following traumatic brain injury (TBI). To answer this question, we will look at changes from before the intervention to after the intervention on questionnaire measures of problem-solving skills, communication, social competence, adjustment, and family stress and burden. We hypothesize that families receiving the TOPS intervention will have better parent-child communication and problem-solving skills at follow-up than those receiving the IRC intervention. Additionally, families receiving the TOPS intervention will have lower levels of parental distress, fewer child behavior problems and better child functioning than those receiving the IRC intervention. Lastly, treatment effects will be moderated by SES and life stresses, such that families with greater social disadvantage will benefit more from the TOPS intervention.
Read the detailed description
Traumatic Brain Injury (TBI) creates significant stress for families resulting in increased burden, anxiety and depression among family members. Both pre- and post-injury family functioning have been linked to child outcomes, suggesting that improvements in family adaptation may result in fewer social and behavioral sequelae in the injured child. Despite this evidence, the development and evaluation of family interventions following TBI are extremely rare.
Children with TBI are often treated at urban trauma centers then discharged to distant home communities where psychosocial follow-up is limited and/or difficult to access. Increasingly, the World Wide Web is being used to meet the mental and other health needs of individuals who have difficulty accessing care through traditional routes. Given the lack of specialized care and follow-up for TBI in many communities, the Web may provide an invaluable tool for linking families with state-of-the-art psychosocial care by reducing potential physical and psychological barriers (e.g., distance, stigma).
Building on previous intervention research of the PI, this study targets the adolescent population between the ages of 12-18. By identifying the unique concerns and issues of this population following brain injury, Teen Online Problem Solving seeks to improve family and teen adaptation, thereby reducing social and behavioral sequelae.
Comparison(s): Teen Online Problem Solving (TOPS) intervention with online curriculum and sequential videoconference therapy sessions in addition to usual care, compared to Internet Resource Comparison with online access to resources in addition to usual care.
- Conditions
- TBI (Traumatic Brain Injury), Brain Edema, Craniocerebral Trauma, Hematoma, Brain Concussion
- Being tested
- Teen Online Problem Solving
- Keywords
- TBI (Traumatic Brain Injury), Intracranial Edema, Brain Edema, Craniocerebral Trauma, Head Injury, Brain Hemorrhage, Traumatic, Subdural Hematoma, Brain Concussion, Head Injuries, Closed
- Medical subject headings
- Brain Injuries, Traumatic, Brain Edema, Craniocerebral Trauma, Hematoma, Brain Concussion, Brain Hemorrhage, Traumatic, Hematoma, Subdural, Head Injuries, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen Online Problem SolvingBehavioural
Also called TOPS, IRC
We will test the following hypotheses: 1) Children with TBI receiving TOPS 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Teen Online Problem Solving | Experimental | 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. Receives: Behavioral: Teen Online Problem Solving |
| Internet Resources Comparison | Experimental | 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. Receives: Behavioral: Teen Online Problem Solving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Report Measures
Measured: 4 years
Secondary outcomes (1)
Teen Self-Report Measures
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startOct 2005
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Shari L Wade, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409058
- Sponsor's protocol ID
- 05-10-36
- Other IDs
- H133G050239
- Acronym
- TOPS
- Status last verified
- Sep 2014
- First submitted
- 7 Dec 2006
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31405391Wade 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 30413559Wade SL, Walz NC, Carey J, McMullen KM, Cass J, Mark E, Yeates KO. A randomized trial of teen online problem solving: efficacy in improving caregiver outcomes after brain injury. Health Psychol. 2012 Nov;31(6):767-76. doi: 10.1037/a0028440. Epub 2012 Jul 2.
PubMed 22746261
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving (TOPS)
- ClinicalTrials.gov ID
- NCT00409058
- Acronym / sponsor ID
- TOPS / 05-10-36
- Conditions
- TBI (Traumatic Brain Injury), Brain Edema, Craniocerebral Trauma, Hematoma, Brain Concussion
- Keywords
- TBI (Traumatic Brain Injury), Intracranial Edema, Brain Edema, Craniocerebral Trauma, Head Injury, Brain Hemorrhage, Traumatic, Subdural Hematoma, Brain Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- Oct 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Dec 2006 (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.
The purpose of this study is to learn if using the World Wide Web to train teens and their families in problem-solving, communication skills, and stress management strategies can help them to cope better following traumatic brain injury (TBI). To answer this question, we will look at changes from before the intervention to after the intervention on questionnaire measures of problem-solving skills, communication, social competence, adjustment, and family stress and burden. We hypothesize that families receiving the TOPS intervention will have better parent-child communication and problem-solving skills at follow-up than those receiving the IRC intervention. Additionally, families receiving the TOPS intervention will have lower levels of parental distress, fewer child behavior problems and better child functioning than those receiving the IRC intervention. Lastly, treatment effects will be moderated by SES and life stresses, such that families with greater social disadvantage will benefit more from the TOPS intervention.
Detailed description
Traumatic Brain Injury (TBI) creates significant stress for families resulting in increased burden, anxiety and depression among family members. Both pre- and post-injury family functioning have been linked to child outcomes, suggesting that improvements in family adaptation may result in fewer social and behavioral sequelae in the injured child. Despite this evidence, the development and evaluation of family interventions following TBI are extremely rare.
Children with TBI are often treated at urban trauma centers then discharged to distant home communities where psychosocial follow-up is limited and/or difficult to access. Increasingly, the World Wide Web is being used to meet the mental and other health needs of individuals who have difficulty accessing care through traditional routes. Given the lack of specialized care and follow-up for TBI in many communities, the Web may provide an invaluable tool for linking families with state-of-the-art psychosocial care by reducing potential physical and psychological barriers (e.g., distance, stigma).
Building on previous intervention research of the PI, this study targets the adolescent population between the ages of 12-18. By identifying the unique concerns and issues of this population following brain injury, Teen Online Problem Solving seeks to improve family and teen adaptation, thereby reducing social and behavioral sequelae.
Comparison(s): Teen Online Problem Solving (TOPS) intervention with online curriculum and sequential videoconference therapy sessions in addition to usual care, compared to Internet Resource Comparison with online access to resources in addition to usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teen Online Problem Solving | Experimental | Behavioral: Teen Online Problem SolvingThe 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. |
| Internet Resources Comparison | Experimental | Behavioral: Teen Online Problem SolvingFamilies 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. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- between 11 and 18 years of age
- moderate to severe traumatic brain injury
- overnight hospital stay
- injury occurred within the last 12 months
Key exclusion criteria (10 listed)
- younger than 11 and older than 18 years of age
- injury occurred more than 12 months ago
- teen does not live with parents or guardian
- English not spoken in the home
- injury is a result of child abuse as documented by medical record
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 SolvingAlso: TOPS, IRCWe will test the following hypotheses: 1) Children with TBI receiving TOPS 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 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. | Behavioural | Internet Resources Comparison, Teen Online Problem Solving |
Primary outcome
Parent Report Measures
Time frame: 4 years
1 secondary outcome
Teen Self-Report Measures
Time frame: 4 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 28 Oct 2014.
- 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 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 22746261Wade SL, Walz NC, Carey J, McMullen KM, Cass J, Mark E, Yeates KO. A randomized trial of teen online problem solving: efficacy in improving caregiver outcomes after brain injury. Health Psychol. 2012 Nov;31(6):767-76. doi: 10.1037/a0028440. Epub 2012 Jul 2.
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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.
Shari L Wade, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
2 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 in people with TBI (Traumatic Brain Injury) and Brain Edema, run by Children's Hospital Medical Center, Cincinnati at 2 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 10 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 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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: 4 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 NCT00409058, which also lists 3 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 28 Oct 2014.