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CISBAR Intervention for Social Communication After ABI

Primary Purpose

Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR)
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Oregon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Participants received a behavioral intervention, CISBAR, via zoom sessions.

Outcomes

Primary Outcome Measures

Number of interruptions
number of times the participant interrupted their partner
Average duration of speaking turn
average number of seconds of speaking turn in conversation with partner

Secondary Outcome Measures

Full Information

First Posted
August 29, 2022
Last Updated
October 27, 2022
Sponsor
University of Oregon
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1. Study Identification

Unique Protocol Identification Number
NCT05603117
Brief Title
CISBAR Intervention for Social Communication After ABI
Official Title
A Single Case Experimental Design Investigating CISBAR Intervention for Improving Social Communication After ABI
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
September 9, 2021 (Actual)
Study Completion Date
October 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oregon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants received a behavioral intervention, CISBAR, via zoom sessions.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of interruptions
Description
number of times the participant interrupted their partner
Time Frame
6-7 minutes
Title
Average duration of speaking turn
Description
average number of seconds of speaking turn in conversation with partner
Time Frame
6-7 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
McKay M Sohlberg, PhD
Organizational Affiliation
University of Oregon
Official's Role
Study Chair
Facility Information:
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

CISBAR Intervention for Social Communication After ABI

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