Roll for Intervention - TBI Group Treatment

Roll for Intervention - a Critical Look at the Practicability of Table-top Roll Playing Games as Communication Intervention for Traumatic Brain Injury

Communication group intervention for individuals with Traumatic Brain Injury based on INSIGHT protocol (Keegan et al, 2020) with roll playing game focus

Study Overview

• Status: Completed
• Conditions: Communication Disorder, Social
• Intervention / Treatment: Behavioral: INSIGHT

Detailed Description

Individuals with TBI recruited to participate in a study about applying INSIGHT protocol to a virtual roll playing game environment. The game 'monsters of the week' will be used to administer the cognitive-communication ingredients outlined by INSIGHT (Keegan et al 2020) and progress towards social communication goals will be documented throughout the course of participating in the roll playing campaign (7-8 weeks - meeting 2 hours each week). The individuals without neurological disorders will follow the same protocol.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18018
      • Moravian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Group 1: individuals who have received a brain injury at least 1 year prior to enrollment.

Group 2: age, education and gender matched individuals who have no history of neurological difficulties

Description

Inclusion Criteria:

• moderate to severe TBI more than 1 year ago

Exclusion Criteria:

• other neurological diagnoses prior to TBI

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals with TBI	Behavioral: INSIGHT; See Keegan et al., 2020

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goal Attainament Scaling - change over time	Assessing change over time on five point scaled goals - goal rated each week for 8 weeks.	Week 2, 3,4,5,6,7, 8 and 9 of the 10week study protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatable Battery for the Assessment of Neuropsychological Status Update	Randolf (2012) standardized norm referenced assessment measure of cognitive skills (memory and attention etc.)	During week 1 and week 10 of the 10 week protocol
Functional Assessment of Verbal Reasoning and Executive Strategies	MacDonald (2005) standardized norm referenced assessment measure of problem solving and reasoning	During week 1 and week 10 of the 10 week protocol
Sydney psychosocial reintegration scale version 2 (SPRS-2)	Tate (2012) standardized likert based questionnaire (12, 1-5 ratings, where higher scores = better performance)	During week 1 and week 10 of the 10 week protocol
Satisfaction with life scale (SWLS)	Diener et al (1985), likert measurement scale questionnaire, 5 1-7 ratings, higher scores = better performance	During week 1 and week 10 of the 10 week protocol
Latrobe Communication Questionnaire (LCQ)	Douglas et al (2000), likert measurement scale questionnaire, 30 1-4 ratings, higher scores = better performance	During week 1 and week 10 of the 10 week protocol

Collaborators and Investigators

• Sponsor: Moravian University
• Investigators: Principal Investigator: Louise C Keegan, Moravian University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Social Communication Disorder; Communication Disorders
• Other Study ID Numbers: 22-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No