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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97404
        • University of Oregon

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. Adults aged 18-80 with reported ABI after age 16.
  2. 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)
  3. 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.
  4. Reported ABI greater than eight months prior with hospitalization of at least one day resulting in changes in cognitive communication
  5. 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.
  6. 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
  7. 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).
  8. 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:

  1. Nominated by the primary participant as a person who talks with the primary participant regularly (at least once per week).
  2. Endorsed by the primary participant as being supportive.
  3. Willing to participate in each session with the primary participant.
  4. 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).
  5. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Participants received a behavioral intervention, CISBAR, via zoom sessions.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of interruptions
Time Frame: 6-7 minutes
number of times the participant interrupted their partner
6-7 minutes
Average duration of speaking turn
Time Frame: 6-7 minutes
average number of seconds of speaking turn in conversation with partner
6-7 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oregon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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