NCT05603117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

August 29, 2022

Last Update Submit

October 27, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of interruptions

    number of times the participant interrupted their partner

    6-7 minutes

  • Average duration of speaking turn

    average number of seconds of speaking turn in conversation with partner

    6-7 minutes

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Collaborative Interpersonal Strategy Building with Audio Reflection (CISBAR)

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97404, United States

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • McKay M Sohlberg, PhD

    University of Oregon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral candidate

Study Record Dates

First Submitted

August 29, 2022

First Posted

November 2, 2022

Study Start

April 30, 2021

Primary Completion

September 9, 2021

Study Completion

October 19, 2021

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
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.

Locations