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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05603117
Other study ID # 12292020.033
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 30, 2021
Est. completion date October 19, 2021

Study information

Verified date October 2022
Source University of Oregon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date October 19, 2021
Est. primary completion date September 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Oregon Eugene Oregon

Sponsors (1)

Lead Sponsor Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of interruptions number of times the participant interrupted their partner 6-7 minutes
Primary Average duration of speaking turn average number of seconds of speaking turn in conversation with partner 6-7 minutes
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