Brain InjuriesNCT05603117
CISBAR Intervention for Social Communication After ABI
A study testing Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR) in people with Brain Injuries, run by University of Oregon at 1 site in United States.
Trial summary
This was the first trial of a new intervention, Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR), for improving social communication in adults following brain injury. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 19 Oct 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria Separate sets of inclusion criteria were used for the primary participants and the ECPs.
Primary Participant Inclusion Criteria:
- Adults aged 18-80 with reported ABI after age 16.
- Access to a computer, mobile phone, or tablet with Internet connectivity and a camera in order to allow participation in Zoom sessions; participation may require assistance of everyday communication partner (ECP)
- Memory ability sufficient to allow meaningful participation in therapy and retention of skills with practice, as determined by the clinician in the initial screening interview with participant and everyday communication partner.
- Reported ABI greater than eight months prior with hospitalization of at least one day resulting in changes in cognitive communication
- Able to identify an ECP (i.e., a close friend or family member with whom the participant talks at least once per week), who is willing to participate in each session and whom the primary participant endorses as supportive.
- Participant and ECP report current challenges in social communication characterized by verbosity (or limited speech), tangentiality and/or difficulty taking the perspective of others which were not apparent before the ABI
- Participant and the ECP both indicate willingness to work on measurable social communication behaviors (specifically interruption, wordiness, limited speech, or perspective taking) using the present intervention. Specifically, both the participant and ECP must score midway or above on the Motivational Interviewing (MI) rulers of confidence in change and importance of change (Miller \& Rollnick, 2013; described below in the Initial Intake section).
- Participants must be able to participate in therapy without significant barriers to treatment posed by severe depression or other mental health issues, as determined by the screening interview with the ECP and primary participant, and results of The Depression Anxiety Stress Scales-21 (DASS-21; Lovibond \& Lovibond, 1995).
ECP Inclusion Criteria:
- Nominated by the primary participant as a person who talks with the primary participant regularly (at least once per week).
- Endorsed by the primary participant as being supportive.
- Willing to participate in each session with the primary participant.
- Indicates readiness to support the participant in working on a communication goal by scoring at least midway on the Motivational Interviewing (MI) rulers of confidence in change and importance of change (Miller \& Rollnick, 2013; described below in the Initial Intake section).
- Demonstrated satisfactory supportiveness in communication as indicated by scores of at least 2 out of 4 on the Measure of Skill in Supported Conversation (MSC) scales of the adapted Kagan Scales (Togher et al., 2010), indicating a basic level of skill in acknowledging competence and revealing competence in the person with ABI, after a short training in supportive communication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Case Experimental Design Investigating CISBAR Intervention for Improving Social Communication After ABI
This was the first trial of a new intervention, Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR), for improving social communication in adults following brain injury. When developing CISBAR, I aimed to provide speech-language pathologists (SLPs) with an integrated package for goal-setting and treatment of social communication after ABI by combining motivational interviewing and goal attainment scaling with evidence-based treatment elements drawn from social cognitive and conversational coaching approaches. To elicit the targeted communication behaviors, CISBAR adds a new system of selecting equivalent conversation topics. To foster self-awareness and reflection, CISBAR incorporates the Conversational Rating System for ABI (CoRS-ABI). I used a single-case experimental, multiple-probe design across participants to evaluate CISBAR.
Read the detailed description
This was the first trial of a new intervention, Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR). CISBAR aims to provide speech-language pathologists (SLPs) with an integrated package for goal-setting and treatment of social communication after ABI by combining motivational interviewing and goal attainment scaling with evidence-based treatment elements drawn from social cognitive and conversational coaching approaches. To elicit the targeted communication behaviors, CISBAR adds a new system of selecting equivalent conversation topics. To foster self-awareness and reflection, CISBAR incorporates the Conversational Rating System for ABI (CoRS-ABI).
- Conditions
- Brain Injuries
- Being tested
- Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR)
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR)Behavioural
CISBAR incorporates collaborative, individualized goal-setting, metacognitive strategy training, audio feedback, reflection, and practice, integrated with the Conversational Rating System for ABI (CoRS-ABI) and adding a new method for selecting individualized and equivalently challenging conversation practice topics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants received a behavioral intervention, CISBAR, via zoom sessions. Receives: Behavioral: Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of interruptions
number of times the participant interrupted their partner
Measured: 6-7 minutes
Average duration of speaking turn
average number of seconds of speaking turn in conversation with partner
Measured: 6-7 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start30 Apr 2021
- Primary completion9 Sep 2021
- Study completion19 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Iwashita, University of Oregon
- Investigators
- McKay M Sohlberg, PhD, Study chair, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603117
- Sponsor's protocol ID
- 12292020.033
- Status last verified
- Oct 2022
- First submitted
- 29 Aug 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: with additional consent given by participants under the oversight of the IRB at Eastern Washington University (EWU), videorecorded intervention sessions may be made available to student researchers for further research.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Case Experimental Design Investigating CISBAR Intervention for Improving Social Communication After ABI
- ClinicalTrials.gov ID
- NCT05603117
- Acronym / sponsor ID
- 12292020.033
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 2 Nov 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.
This was the first trial of a new intervention, Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR), for improving social communication in adults following brain injury. When developing CISBAR, I aimed to provide speech-language pathologists (SLPs) with an integrated package for goal-setting and treatment of social communication after ABI by combining motivational interviewing and goal attainment scaling with evidence-based treatment elements drawn from social cognitive and conversational coaching approaches. To elicit the targeted communication behaviors, CISBAR adds a new system of selecting equivalent conversation topics. To foster self-awareness and reflection, CISBAR incorporates the Conversational Rating System for ABI (CoRS-ABI). I used a single-case experimental, multiple-probe design across participants to evaluate CISBAR.
Detailed description
This was the first trial of a new intervention, Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR). CISBAR aims to provide speech-language pathologists (SLPs) with an integrated package for goal-setting and treatment of social communication after ABI by combining motivational interviewing and goal attainment scaling with evidence-based treatment elements drawn from social cognitive and conversational coaching approaches. To elicit the targeted communication behaviors, CISBAR adds a new system of selecting equivalent conversation topics. To foster self-awareness and reflection, CISBAR incorporates the Conversational Rating System for ABI (CoRS-ABI).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR)Participants received a behavioral intervention, CISBAR, via zoom sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR)CISBAR incorporates collaborative, individualized goal-setting, metacognitive strategy training, audio feedback, reflection, and practice, integrated with the Conversational Rating System for ABI (CoRS-ABI) and adding a new method for selecting individualized and equivalently challenging conversation practice topics. | Behavioural | Intervention |
Primary outcome
Number of interruptions
Time frame: 6-7 minutes
number of times the participant interrupted their partner
Average duration of speaking turn
Time frame: 6-7 minutes
average number of seconds of speaking turn in conversation with partner
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 2 Nov 2022.
- Individual participant dataSharing planned: Yes. with additional consent given by participants under the oversight of the IRB at Eastern Washington University (EWU), videorecorded intervention sessions may be made available to student researchers for further research.
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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.
McKay M Sohlberg, PhD study chair
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 Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR) in people with Brain Injuries, 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?
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 2 Nov 2022. 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?
Number of interruptions (time frame: 6-7 minutes). 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?
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 2 Nov 2022.