Traumatic Brain InjuryCAPSNCT00409448
Internet-Based Treatment for Children With Traumatic Brain Injuries & Their Families: Counselor Assisted Problem Solving
A study testing Counselor-assisted problem solving (CAPS) and Internet-resource 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 children who have had a traumatic brain injury and their families. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Counselor-assisted problem solving (CAPS) and Internet-resource comparison (IRC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2007to Aug 2012
- 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 12 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 6 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 nonblunt 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
Cincinnati, Ohio, 45229
MetroHealth Medical Center
Cleveland, Ohio, 44106
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Denver Children's Hospital
Denver, Colorado, 80045
The Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Improving Mental Health Outcomes of Child Brain Injury
This study will evaluate the effectiveness of an Internet-based psychosocial treatment in improving problem-solving, communication skills, stress management strategies, and coping among children who have had a traumatic brain injury and their families.
Read the detailed description
A traumatic brain injury (TBI) is caused by a strong blow, jolt, or penetration to the head that disrupts normal brain functioning. A TBI can range from a mild concussion to severe brain damage. Falls, assaults, and motor vehicle accidents account for more than 50% of TBIs. Physical symptoms of a TBI can be subtle to severe and can include nausea, memory loss, mood swings, blurred vision, and light-headedness. This type of injury can be very stressful for families and can result in feelings of anxiety, burden, and depression among family members. A child who experiences a TBI will often display new social and behavioral problems, leading to further parental distress and increased family dysfunction. Recent studies have shown that problem-solving interventions can reduce caregiver distress and improve child adjustment following a TBI. However, access to skilled therapists and specialized care for this kind of psychosocial treatment is often limited in many communities. In such communities, the Internet offers a new way to meet the mental and other health needs of individuals with TBIs. 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 TBI and their families.
Families participating in this study will be randomly assigned to either an Internet-based counselor-assisted problem-solving (CAPS) group or an Internet resource comparison group (IRC). Participants assigned to CAPS will work with a trained counselor who will guide them through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions. Families assigned to IRC will receive computers, high speed Internet access, and links to brain injury information and resources, but no access to the CAPS Web site content. The effectiveness of CAPS will be assessed after treatment and at 6- and 12-month follow-up evaluations.
- Conditions
- Traumatic Brain Injury
- Being tested
- Counselor-assisted problem solving (CAPS), Internet-resource 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
- 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.
Counselor-assisted problem solving (CAPS)Behavioural
In CAPS, a trained counselor will guide families through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions.
Internet-resource comparison (IRC)Behavioural
Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources, but not the CAPS website content.
| Study group | Role | What they receive |
|---|---|---|
| CAPS | Experimental | Participants will receive the Internet-based counselor-assisted problem-solving group treatment Receives: Behavioral: Counselor-assisted problem solving (CAPS) |
| IRC | Active comparator | Participants will receive the Internet resource comparison group treatment Receives: Behavioral: Internet-resource 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
Teen self-report measures
Measured: 5 years
Secondary outcomes (1)
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 posted8 Dec 2006 (estimated)
- Study startMar 2007
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari L. Wade, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409448
- Sponsor's protocol ID
- R01MH073764
- Other IDs
- DDTR B2-NDA
- Acronym
- CAPS
- Status last verified
- Sep 2014
- First submitted
- 7 Dec 2006
- Last updated
- 19 Sep 2014
- 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, 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 30413559Huebner ARS, Cassedy A, Brown TM, Taylor HG, Stancin T, Kirkwood MW, Wade SL. Use of Mental Health Services by Adolescents After Traumatic Brain Injury: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2018 May;10(5):462-471. doi: 10.1016/j.pmrj.2017.10.004. Epub 2017 Oct 31.
PubMed 29097272Narad ME, Minich N, Taylor HG, Kirkwood MW, Brown TM, Stancin T, Wade SL. Effects of a Web-Based Intervention on Family Functioning Following Pediatric Traumatic Brain Injury. J Dev Behav Pediatr. 2015 Nov-Dec;36(9):700-7. doi: 10.1097/DBP.0000000000000208.
PubMed 26461100Wade SL, Taylor HG, Cassedy A, Zhang N, Kirkwood MW, Brown TM, Stancin T. Long-Term Behavioral Outcomes after a Randomized, Clinical Trial of Counselor-Assisted Problem Solving for Adolescents with Complicated Mild-to-Severe Traumatic Brain Injury. J Neurotrauma. 2015 Jul 1;32(13):967-75. doi: 10.1089/neu.2014.3684. Epub 2015 May 7.
PubMed 25738891Wade SL, Kurowski BG, Kirkwood MW, Zhang N, Cassedy A, Brown TM, Nielsen B, Stancin T, Taylor HG. Online problem-solving therapy after traumatic brain injury: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):e487-95. doi: 10.1542/peds.2014-1386. Epub 2015 Jan 12.
PubMed 25583911Kurowski BG, Wade SL, Kirkwood MW, Brown TM, Stancin T, Taylor HG. Long-term benefits of an early online problem-solving intervention for executive dysfunction after traumatic brain injury in children: a randomized clinical trial. JAMA Pediatr. 2014 Jun;168(6):523-31. doi: 10.1001/jamapediatrics.2013.5070.
PubMed 24781374Arnett AB, Peterson RL, Kirkwood MW, Taylor HG, Stancin T, Brown TM, Wade SL. Behavioral and cognitive predictors of educational outcomes in pediatric traumatic brain injury. J Int Neuropsychol Soc. 2013 Sep;19(8):881-9. doi: 10.1017/S1355617713000635. Epub 2013 Jun 21.
PubMed 23790158Kurowski BG, Wade SL, Kirkwood MW, Brown TM, Stancin T, Taylor HG. Online problem-solving therapy for executive dysfunction after child traumatic brain injury. Pediatrics. 2013 Jul;132(1):e158-66. doi: 10.1542/peds.2012-4040. Epub 2013 Jun 10.
PubMed 23753094Wade SL, Stancin T, Kirkwood M, Brown TM, McMullen KM, Taylor HG. Counselor-assisted problem solving (CAPS) improves behavioral outcomes in older adolescents with complicated mild to severe TBI. J Head Trauma Rehabil. 2014 May-Jun;29(3):198-207. doi: 10.1097/HTR.0b013e31828f9fe8.
PubMed 23640543
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health Outcomes of Child Brain Injury
- ClinicalTrials.gov ID
- NCT00409448
- Acronym / sponsor ID
- CAPS / R01MH073764
- 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
- 132 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (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.
This study will evaluate the effectiveness of an Internet-based psychosocial treatment in improving problem-solving, communication skills, stress management strategies, and coping among children who have had a traumatic brain injury and their families.
Detailed description
A traumatic brain injury (TBI) is caused by a strong blow, jolt, or penetration to the head that disrupts normal brain functioning. A TBI can range from a mild concussion to severe brain damage. Falls, assaults, and motor vehicle accidents account for more than 50% of TBIs. Physical symptoms of a TBI can be subtle to severe and can include nausea, memory loss, mood swings, blurred vision, and light-headedness. This type of injury can be very stressful for families and can result in feelings of anxiety, burden, and depression among family members. A child who experiences a TBI will often display new social and behavioral problems, leading to further parental distress and increased family dysfunction. Recent studies have shown that problem-solving interventions can reduce caregiver distress and improve child adjustment following a TBI. However, access to skilled therapists and specialized care for this kind of psychosocial treatment is often limited in many communities. In such communities, the Internet offers a new way to meet the mental and other health needs of individuals with TBIs. 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 TBI and their families.
Families participating in this study will be randomly assigned to either an Internet-based counselor-assisted problem-solving (CAPS) group or an Internet resource comparison group (IRC). Participants assigned to CAPS will work with a trained counselor who will guide them through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions. Families assigned to IRC will receive computers, high speed Internet access, and links to brain injury information and resources, but no access to the CAPS Web site content. The effectiveness of CAPS will be assessed after treatment and at 6- and 12-month follow-up evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAPS | Experimental | Behavioral: Counselor-assisted problem solving (CAPS)Participants will receive the Internet-based counselor-assisted problem-solving group treatment |
| IRC | Active comparator | Behavioral: Internet-resource comparison (IRC)Participants will receive the Internet resource comparison group treatment |
Who may qualify
- Ages
- 12 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 6 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 nonblunt 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 |
|---|---|---|
| Counselor-assisted problem solving (CAPS)In CAPS, a trained counselor will guide families through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions. | Behavioural | CAPS |
| Internet-resource comparison (IRC)Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources, but not the CAPS website content. | Behavioural | IRC |
Primary outcome
Parent report measures
Time frame: 5 years
Teen self-report measures
Time frame: 5 years
1 secondary outcome
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 19 Sep 2014.
- 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 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 29097272Huebner ARS, Cassedy A, Brown TM, Taylor HG, Stancin T, Kirkwood MW, Wade SL. Use of Mental Health Services by Adolescents After Traumatic Brain Injury: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2018 May;10(5):462-471. doi: 10.1016/j.pmrj.2017.10.004. Epub 2017 Oct 31.
- Derived from this study: PubMed 26461100Narad ME, Minich N, Taylor HG, Kirkwood MW, Brown TM, Stancin T, Wade SL. Effects of a Web-Based Intervention on Family Functioning Following Pediatric Traumatic Brain Injury. J Dev Behav Pediatr. 2015 Nov-Dec;36(9):700-7. doi: 10.1097/DBP.0000000000000208.
- Derived from this study: PubMed 25738891Wade SL, Taylor HG, Cassedy A, Zhang N, Kirkwood MW, Brown TM, Stancin T. Long-Term Behavioral Outcomes after a Randomized, Clinical Trial of Counselor-Assisted Problem Solving for Adolescents with Complicated Mild-to-Severe Traumatic Brain Injury. J Neurotrauma. 2015 Jul 1;32(13):967-75. doi: 10.1089/neu.2014.3684. Epub 2015 May 7.
- Derived from this study: PubMed 25583911Wade SL, Kurowski BG, Kirkwood MW, Zhang N, Cassedy A, Brown TM, Nielsen B, Stancin T, Taylor HG. Online problem-solving therapy after traumatic brain injury: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):e487-95. doi: 10.1542/peds.2014-1386. Epub 2015 Jan 12.
- Derived from this study: PubMed 24781374Kurowski BG, Wade SL, Kirkwood MW, Brown TM, Stancin T, Taylor HG. Long-term benefits of an early online problem-solving intervention for executive dysfunction after traumatic brain injury in children: a randomized clinical trial. JAMA Pediatr. 2014 Jun;168(6):523-31. doi: 10.1001/jamapediatrics.2013.5070.
- Derived from this study: PubMed 23790158Arnett AB, Peterson RL, Kirkwood MW, Taylor HG, Stancin T, Brown TM, Wade SL. Behavioral and cognitive predictors of educational outcomes in pediatric traumatic brain injury. J Int Neuropsychol Soc. 2013 Sep;19(8):881-9. doi: 10.1017/S1355617713000635. Epub 2013 Jun 21.
- Derived from this study: PubMed 23753094Kurowski BG, Wade SL, Kirkwood MW, Brown TM, Stancin T, Taylor HG. Online problem-solving therapy for executive dysfunction after child traumatic brain injury. Pediatrics. 2013 Jul;132(1):e158-66. doi: 10.1542/peds.2012-4040. Epub 2013 Jun 10.
- Derived from this study: PubMed 23640543Wade SL, Stancin T, Kirkwood M, Brown TM, McMullen KM, Taylor HG. Counselor-assisted problem solving (CAPS) improves behavioral outcomes in older adolescents with complicated mild to severe TBI. J Head Trauma Rehabil. 2014 May-Jun;29(3):198-207. doi: 10.1097/HTR.0b013e31828f9fe8.
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselor-assisted problem solving (CAPS) and Internet-resource 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 19 Sep 2014. 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). The study lists 2 primary outcomes in all. 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 NCT00409448, which also lists 10 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 19 Sep 2014.