- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05603117
CISBAR Intervention for Social Communication After ABI
October 27, 2022 updated by: Heidi Iwashita, University of Oregon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Eugene, Oregon, United States, 97404
- University of Oregon
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
Participants received a behavioral intervention, CISBAR, via zoom sessions.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of interruptions
Time Frame: 6-7 minutes
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number of times the participant interrupted their partner
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6-7 minutes
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Average duration of speaking turn
Time Frame: 6-7 minutes
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average number of seconds of speaking turn in conversation with partner
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6-7 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: McKay M Sohlberg, PhD, University of Oregon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2021
Primary Completion (Actual)
September 9, 2021
Study Completion (Actual)
October 19, 2021
Study Registration Dates
First Submitted
August 29, 2022
First Submitted That Met QC Criteria
October 27, 2022
First Posted (Actual)
November 2, 2022
Study Record Updates
Last Update Posted (Actual)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 27, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12292020.033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
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.
IPD Sharing Time Frame
Two participants have given additional consent for their data to be used by a research student for further analysis.
The time frame of access is under the oversight of the EWU IRB according to the protocol of a separate IRB-approved study.
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.