Brain Injuries, TraumaticTIPSNCT03867968
Traumatic Brain Injury Positive Strategies
A study testing TIPS Intervention in people with Brain Injuries, Traumatic, run by University of Oregon at 1 site in United States.
Trial summary
This study evaluates the effectiveness of The Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills in supporting a child with TBI experiencing cognitive, behavioral, and social challenges. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- TIPS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to 6 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult 18 years old or older
- Have a child age 3-18 that was hospitalized overnight with a traumatic brain injury (TBI).
- Involved in the care and support of the child with the TBI.
- Live in the same household as child with a TBI.
- The child with the TBI is able to follow simple instructions such as "please eat your toast."
Who cannot join
- Does not speak and read English.
- Does not have high speed Internet access.
- Not US resident
Trial locations and contacts
1 site in 1 country.
United States1 site
Center on Brain Injury Research and Training / University of Oregon
Eugene, Oregon, 97403
About this study
Official title: Brain Injury Support and Strategies for Families Impacted by Childhood TBI
This study evaluates the effectiveness of The Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills in supporting a child with TBI experiencing cognitive, behavioral, and social challenges. The application provides training in evidence-based support strategies with the goal of improving outcomes for children with TBI and their families. Half the participants will receive access to the TIPS program, while the other half will receive access to a different TBI related website.
Read the detailed description
Due to the chronic nature of cognitive and behavioral problems related to TBI, parents and other family caregivers need information, resources, and training in evidence-based strategies to manage the varied and changing concerns following their child's injury. Recent research provides evidence that theory-driven, self-directed online parent training is effective in improving both child and parent outcomes.
The objective of this project is to produce the Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills to address cognitive, behavioral, and social challenges following pediatric TBI. The TIPS program will be grounded in the theory of planned behavior, which postulates that training in problem-solving leads to improved skills and increases in perceived behavioral control that mediate direct changes in parenting behaviors and indirect changes in child outcomes. The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI.
Approximately 216 family members will participate in the evaluation phase of this study. Participants will be randomly assigned to one of two conditions: (a) treatment (TIPS program ) or (b) control (brain injury website).
- Conditions
- Brain Injuries, Traumatic
- Being tested
- TIPS Intervention, Control
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPS InterventionBehavioural
Web-based training for family member.
ControlBehavioural
Traumatic Brain Injury website for family members.
| Study group | Role | What they receive |
|---|---|---|
| TIPS Intervention | Experimental | The Traumatic Brain Injury Positive Strategies (TIPS) program, is a comprehensive educational and training resource to help families. The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI. Receives: Behavioral: TIPS Intervention |
| Control | Active comparator | An existing website related to traumatic brain injury. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIPS Change in Knowledge Survey
Survey to assess change in knowledge of research-based cognitive, behavioral, and social support strategies and self-efficacy about using those strategies in home and community settings.
Measured: Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
PedsQL Family Impact
Administered to measure change in impact of pediatric acute and chronic health conditions on parents and the family.
Measured: Baseline and for a 3 month follow up after completed intervention.
Caregiver Self-Efficacy Scale
25-question self-report measure, administered to measure the change in how comfortable caregivers feel about selected aspects of their parenting skills such as managing their child's behavior, being an advocate for their child, and dealing with school-related issues.
Measured: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
Secondary outcomes (3)
The Pediatric Quality of Life Inventory (PedsQL)
23 items measuring physical, emotional, social, and school function. Caregiver report forms have been developed for children 2-18 years. The PedsQL has been used in pediatric TBI as a quality of life outcome.
Measured: Baseline
PedsQL Cognitive Function
Measures cognitive functioning in patients with acute and chronic health conditions as well as healthy school and community populations.
Measured: Baseline
Health Behavior Inventory (HBI)
20 items measuring the change in frequency of common brain injury symptoms (somatic, cognitive, and emotional). It will also be used to examine the effectiveness of the interventions in promoting symptom reduction.
Measured: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start13 Feb 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 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 Injuries, TraumaticStudies 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ann Glang, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867968
- Sponsor's protocol ID
- R44HD059255
- Other IDs
- 5R44HD059255-04
- Acronym
- TIPS
- Status last verified
- Apr 2020
- First submitted
- 17 Jan 2019
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karns CM, Wade SL, Slocumb J, Keating T, Gau JM, Slomine BS, Suskauer SJ, Glang A. Traumatic Brain Injury Positive Strategies for Families: A Pilot Randomized Controlled Trial of an Online Parent-Training Program. Arch Phys Med Rehabil. 2023 Jul;104(7):1026-1034. doi: 10.1016/j.apmr.2023.03.013. Epub 2023 May 2.
PubMed 37142177
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Injury Support and Strategies for Families Impacted by Childhood TBI
- ClinicalTrials.gov ID
- NCT03867968
- Acronym / sponsor ID
- TIPS / R44HD059255
- Conditions
- Brain Injuries, Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 8 Mar 2019 (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.
This study evaluates the effectiveness of The Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills in supporting a child with TBI experiencing cognitive, behavioral, and social challenges. The application provides training in evidence-based support strategies with the goal of improving outcomes for children with TBI and their families. Half the participants will receive access to the TIPS program, while the other half will receive access to a different TBI related website.
Detailed description
Due to the chronic nature of cognitive and behavioral problems related to TBI, parents and other family caregivers need information, resources, and training in evidence-based strategies to manage the varied and changing concerns following their child's injury. Recent research provides evidence that theory-driven, self-directed online parent training is effective in improving both child and parent outcomes.
The objective of this project is to produce the Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills to address cognitive, behavioral, and social challenges following pediatric TBI. The TIPS program will be grounded in the theory of planned behavior, which postulates that training in problem-solving leads to improved skills and increases in perceived behavioral control that mediate direct changes in parenting behaviors and indirect changes in child outcomes. The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI.
Approximately 216 family members will participate in the evaluation phase of this study. Participants will be randomly assigned to one of two conditions: (a) treatment (TIPS program ) or (b) control (brain injury website).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS Intervention | Experimental | Behavioral: TIPS InterventionThe Traumatic Brain Injury Positive Strategies (TIPS) program, is a comprehensive educational and training resource to help families. The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI. |
| Control | Active comparator | Behavioral: ControlAn existing website related to traumatic brain injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult 18 years old or older
- Have a child age 3-18 that was hospitalized overnight with a traumatic brain injury (TBI).
- Involved in the care and support of the child with the TBI.
- Live in the same household as child with a TBI.
- The child with the TBI is able to follow simple instructions such as "please eat your toast."
Key exclusion criteria (3 listed)
- Does not speak and read English.
- Does not have high speed Internet access.
- Not US resident
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 |
|---|---|---|
| TIPS InterventionWeb-based training for family member. | Behavioural | TIPS Intervention |
| ControlTraumatic Brain Injury website for family members. | Behavioural | Control |
Primary outcome
TIPS Change in Knowledge Survey
Time frame: Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
Survey to assess change in knowledge of research-based cognitive, behavioral, and social support strategies and self-efficacy about using those strategies in home and community settings.
PedsQL Family Impact
Time frame: Baseline and for a 3 month follow up after completed intervention.
Administered to measure change in impact of pediatric acute and chronic health conditions on parents and the family.
Caregiver Self-Efficacy Scale
Time frame: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
25-question self-report measure, administered to measure the change in how comfortable caregivers feel about selected aspects of their parenting skills such as managing their child's behavior, being an advocate for their child, and dealing with school-related issues.
3 secondary outcomes
The Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline
PedsQL Cognitive Function
Time frame: Baseline
Health Behavior Inventory (HBI)
Time frame: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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 Apr 2020.
- Derived from this study: PubMed 37142177Karns CM, Wade SL, Slocumb J, Keating T, Gau JM, Slomine BS, Suskauer SJ, Glang A. Traumatic Brain Injury Positive Strategies for Families: A Pilot Randomized Controlled Trial of an Online Parent-Training Program. Arch Phys Med Rehabil. 2023 Jul;104(7):1026-1034. doi: 10.1016/j.apmr.2023.03.013. Epub 2023 May 2.
- Individual participant dataSharing planned: No
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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.
Ann Glang, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIPS Intervention in people with Brain Injuries, Traumatic, run by University of Oregon 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 5 inclusion and 3 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 Apr 2020. 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?
TIPS Change in Knowledge Survey (time frame: Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.). The study lists 3 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 NCT03867968, 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 8 Apr 2020.