Communication Disorder, SocialNCT05517161
Roll for Intervention - TBI Group Treatment
An observational study of Communication Disorder, Social, run by Moravian University at 1 site in United States.
Trial summary
Communication group intervention for individuals with Traumatic Brain Injury based on INSIGHT protocol (Keegan et al, 2020) with roll playing game focus Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Communication Disorder, Social
- What is being tested?
- INSIGHT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 1 May 2023
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: individuals who have received a brain injury at least 1 year prior to enrollment. Group 2: age, education and gender matched individuals who have no history of neurological difficulties
Who may be able to join
- moderate to severe TBI more than 1 year ago
Who cannot join
- other neurological diagnoses prior to TBI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Roll for Intervention - a Critical Look at the Practicability of Table-top Roll Playing Games as Communication Intervention for Traumatic Brain Injury
Communication group intervention for individuals with Traumatic Brain Injury based on INSIGHT protocol (Keegan et al, 2020) with roll playing game focus
Read the detailed description
Individuals with TBI recruited to participate in a study about applying INSIGHT protocol to a virtual roll playing game environment. The game 'monsters of the week' will be used to administer the cognitive-communication ingredients outlined by INSIGHT (Keegan et al 2020) and progress towards social communication goals will be documented throughout the course of participating in the roll playing campaign (7-8 weeks - meeting 2 hours each week). The individuals without neurological disorders will follow the same protocol.
- Conditions
- Communication Disorder, Social
- Being tested
- INSIGHT
- Medical subject headings
- Social Communication Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSIGHTBehavioural
See Keegan et al., 2020
| Study group | Role | What they receive |
|---|---|---|
| Individuals with TBI | Not described Receives: Behavioral: INSIGHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainament Scaling - change over time
Assessing change over time on five point scaled goals - goal rated each week for 8 weeks.
Measured: Week 2, 3,4,5,6,7, 8 and 9 of the 10week study protocol
Secondary outcomes (5)
Repeatable Battery for the Assessment of Neuropsychological Status Update
Randolf (2012) standardized norm referenced assessment measure of cognitive skills (memory and attention etc.)
Measured: During week 1 and week 10 of the 10 week protocol
Functional Assessment of Verbal Reasoning and Executive Strategies
MacDonald (2005) standardized norm referenced assessment measure of problem solving and reasoning
Measured: During week 1 and week 10 of the 10 week protocol
Sydney psychosocial reintegration scale version 2 (SPRS-2)
Tate (2012) standardized likert based questionnaire (12, 1-5 ratings, where higher scores = better performance)
Measured: During week 1 and week 10 of the 10 week protocol
Satisfaction with life scale (SWLS)
Diener et al (1985), likert measurement scale questionnaire, 5 1-7 ratings, higher scores = better performance
Measured: During week 1 and week 10 of the 10 week protocol
Latrobe Communication Questionnaire (LCQ)
Douglas et al (2000), likert measurement scale questionnaire, 30 1-4 ratings, higher scores = better performance
Measured: During week 1 and week 10 of the 10 week protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start2 May 2022
- Primary completion20 Dec 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication Disorder, SocialStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moravian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Keegan, Moravian University
- Investigators
- Louise C Keegan, Principal investigator, Moravian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517161
- Sponsor's protocol ID
- 22-015
- Status last verified
- Oct 2023
- First submitted
- 23 Aug 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roll for Intervention - a Critical Look at the Practicability of Table-top Roll Playing Games as Communication Intervention for Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05517161
- Acronym / sponsor ID
- 22-015
- Conditions
- Communication Disorder, Social
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Moravian UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 26 Aug 2022 (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.
Communication group intervention for individuals with Traumatic Brain Injury based on INSIGHT protocol (Keegan et al, 2020) with roll playing game focus
Detailed description
Individuals with TBI recruited to participate in a study about applying INSIGHT protocol to a virtual roll playing game environment. The game 'monsters of the week' will be used to administer the cognitive-communication ingredients outlined by INSIGHT (Keegan et al 2020) and progress towards social communication goals will be documented throughout the course of participating in the roll playing campaign (7-8 weeks - meeting 2 hours each week). The individuals without neurological disorders will follow the same protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with TBI | – | Behavioral: INSIGHT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: individuals who have received a brain injury at least 1 year prior to enrollment. Group 2: age, education and gender matched individuals who have no history of neurological difficulties
Key inclusion criteria (1 listed)
- moderate to severe TBI more than 1 year ago
Key exclusion criteria (1 listed)
- other neurological diagnoses prior to TBI
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 |
|---|---|---|
| INSIGHTSee Keegan et al., 2020 | Behavioural | Individuals with TBI |
Primary outcome
Goal Attainament Scaling - change over time
Time frame: Week 2, 3,4,5,6,7, 8 and 9 of the 10week study protocol
Assessing change over time on five point scaled goals - goal rated each week for 8 weeks.
5 secondary outcomes
Repeatable Battery for the Assessment of Neuropsychological Status Update
Time frame: During week 1 and week 10 of the 10 week protocol
Functional Assessment of Verbal Reasoning and Executive Strategies
Time frame: During week 1 and week 10 of the 10 week protocol
Sydney psychosocial reintegration scale version 2 (SPRS-2)
Time frame: During week 1 and week 10 of the 10 week protocol
Satisfaction with life scale (SWLS)
Time frame: During week 1 and week 10 of the 10 week protocol
Latrobe Communication Questionnaire (LCQ)
Time frame: During week 1 and week 10 of the 10 week protocol
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 23 Oct 2023.
- 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.
Louise C Keegan principal investigator
Moravian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Communication Disorder, Social, run by Moravian University 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 1 inclusion and 1 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 23 Oct 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?
Goal Attainament Scaling - change over time (time frame: Week 2, 3,4,5,6,7, 8 and 9 of the 10week study protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2023.