Roll for Intervention - TBI Group Treatment

Completed

• Conditions: Communication Disorder, Social
• Interventions: Behavioral: INSIGHT

• Registration Number: NCT05517161
• Lead Sponsor: Moravian University

Brief Summary

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

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 Timeline

• Study Start: 2022-05-02
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-26
• Primary Completion: 2022-12-20
• Study Completion: 2023-05-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• moderate to severe TBI more than 1 year ago

Exclusion Criteria

• other neurological diagnoses prior to TBI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with TBI	INSIGHT	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Moravian University; 🇺🇸 Bethlehem, Pennsylvania, United States