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

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

    • 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

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
Intervention / Treatment
Experimental: Intervention
Participants received a behavioral intervention, CISBAR, via zoom sessions.
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

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.

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

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.

Subscribe