Brain Injury Traumatic MildSMARTNCT03498495
Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program for Kids With Mild Traumatic Brain Injury
A study testing Self-Monitoring Activity-restriction and Relaxation Training (SMART) in people with Brain Injury Traumatic Mild, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
SMART is an interactive web-based program that will allow youth with mild traumatic brain injuries (mTBI) to monitor their symptoms and receive education on problem-solving and coping strategies. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Brain Injury Traumatic Mild
- What is being tested?
- Self-Monitoring Activity-restriction and Relaxation Training (SMART)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2019to 31 Aug 2020
- 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
- 11-18 years old
- Sustained mTBI within the past week
Who cannot join
- Patient and/or family do not speak and read English
- Patient and/or family do not have Internet access
- Patient experiencing more severe brain injury (Glasgow coma score <13)
- Patient with more than one moderate extracranial injury
- Patients with non-mTBI reasons for altered mental status
- Patients with severe pre-existing neurologic or cognitive disorders or other disorders that may impair ability to participate in the intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Kids With mTBI Get SMART: Development and Pilot Trial of a Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program
SMART is an interactive web-based program that will allow youth with mild traumatic brain injuries (mTBI) to monitor their symptoms and receive education on problem-solving and coping strategies. This study will evaluate the effectiveness of SMART as a means of improving symptom-management, coping skills, and general well-being during recovery from mTBI. Half of participants will receive the SMART intervention, while half will receive usual care.
- Conditions
- Brain Injury Traumatic Mild
- Being tested
- Self-Monitoring Activity-restriction and Relaxation Training (SMART)
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Monitoring Activity-restriction and Relaxation Training (SMART)Behavioural
SMART integrates real-time self-monitoring of symptoms and activities with interactive modules designed to increase self-efficacy through psychoeducation and training in problem solving/problem-focused coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| SMART Intervention | Experimental | Not described Receives: Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART) |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)
The PedsQL includes 23 items measuring physical, emotional, social, and school functioning.
Measured: From baseline to 4 weeks post-injury
Secondary outcomes (4)
Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form)
The CSI-S is a coping styles measure and has been used with other pediatric TBI samples. Adolescents rate how much they agree with 32-statements regarding different ways of coping with difficult situations on a 5-point Likert scale. Responses are then grouped into primary subscales reflecting eight different coping strategies (e.g., problem-solving, problem avoidance, social withdrawal, etc.).
Measured: From baseline to 4 weeks post-injury
Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS)
This 2-item measure will be developed by the research team based on Bandura's self-efficacy theory. Adolescents will rate their level of confidence that they are able to maintain a plan to manage their symptoms each week
Measured: From baseline to 4 weeks post-injury
Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS collects data from the adolescent participant and the parent about the impact a condition has on the adolescent's functioning.
Measured: From baseline to 4 weeks post-injury
Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI)
The HBI is a 20-item questionnaire which includes a variety of cognitive, somatic, emotional, and behavioral symptoms requiring parents and adolescents to rate the frequency of occurrence of each symptom over the past week on a 4-point scale, ranging from "never" to "often."
Measured: From baseline to 4 weeks post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start12 May 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injury Traumatic MildStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Lynn Babcock, M.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498495
- Sponsor's protocol ID
- CIN001--SMART
- Acronym
- SMART
- Status last verified
- Jul 2023
- First submitted
- 4 Apr 2018
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wade SL, Sidol C, Babcock L, Schmidt M, Kurowski B, Cassedy A, Zhang N. Findings from a Randomized Controlled Trial of SMART: An EHealth Intervention for Mild Traumatic Brain Injury. J Pediatr Psychol. 2023 Mar 20;48(3):241-253. doi: 10.1093/jpepsy/jsac086.
PubMed 36565462
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kids With mTBI Get SMART: Development and Pilot Trial of a Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program
- ClinicalTrials.gov ID
- NCT03498495
- Acronym / sponsor ID
- SMART / CIN001--SMART
- Conditions
- Brain Injury Traumatic Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- 12 May 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 Apr 2018 (actual)
- 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.
SMART is an interactive web-based program that will allow youth with mild traumatic brain injuries (mTBI) to monitor their symptoms and receive education on problem-solving and coping strategies. This study will evaluate the effectiveness of SMART as a means of improving symptom-management, coping skills, and general well-being during recovery from mTBI. Half of participants will receive the SMART intervention, while half will receive usual care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART Intervention | Experimental | Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART) |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 11-18 years old
- Sustained mTBI within the past week
Key exclusion criteria (6 listed)
- Patient and/or family do not speak and read English
- Patient and/or family do not have Internet access
- Patient experiencing more severe brain injury (Glasgow coma score <13)
- Patient with more than one moderate extracranial injury
- Patients with non-mTBI reasons for altered mental status
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 |
|---|---|---|
| Self-Monitoring Activity-restriction and Relaxation Training (SMART)SMART integrates real-time self-monitoring of symptoms and activities with interactive modules designed to increase self-efficacy through psychoeducation and training in problem solving/problem-focused coping strategies. | Behavioural | SMART Intervention |
Primary outcome
Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)
Time frame: From baseline to 4 weeks post-injury
The PedsQL includes 23 items measuring physical, emotional, social, and school functioning.
4 secondary outcomes
Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form)
Time frame: From baseline to 4 weeks post-injury
Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS)
Time frame: From baseline to 4 weeks post-injury
Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: From baseline to 4 weeks post-injury
Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI)
Time frame: From baseline to 4 weeks post-injury
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 10 Jul 2023.
- Derived from this study: PubMed 36565462Wade SL, Sidol C, Babcock L, Schmidt M, Kurowski B, Cassedy A, Zhang N. Findings from a Randomized Controlled Trial of SMART: An EHealth Intervention for Mild Traumatic Brain Injury. J Pediatr Psychol. 2023 Mar 20;48(3):241-253. doi: 10.1093/jpepsy/jsac086.
- Individual participant dataSharing planned: Undecided
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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.
Lynn Babcock, M.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Monitoring Activity-restriction and Relaxation Training (SMART) in people with Brain Injury Traumatic Mild, run by Children's Hospital Medical Center, Cincinnati at 1 site 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 2 inclusion and 6 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 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL) (time frame: From baseline to 4 weeks post-injury). 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 NCT03498495, which also lists 1 linked publication.
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 10 Jul 2023.