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OpenTrials
Completed

NCT Number: NCT05517161

Roll for Intervention - TBI Group Treatment

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

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Key information

Conditions

Communication Disorder, Social Communication Disorders Mental Disorders Neurodevelopmental Disorders Social Communication Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Moravian University

Bethlehem, Pennsylvania, 18018, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • moderate to severe TBI more than 1 year ago

Exclusion criteria

  • other neurological diagnoses prior to TBI

Treatment and study plan

Insight

Behavioral

See Keegan et al., 2020

Primary outcomes

  1. Goal Attainament Scaling - change over time

    Time frame: 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 outcomes

  1. Repeatable Battery for the Assessment of Neuropsychological Status Update

    Time frame: 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.)

  2. Functional Assessment of Verbal Reasoning and Executive Strategies

    Time frame: During week 1 and week 10 of the 10 week protocol

    MacDonald (2005) standardized norm referenced assessment measure of problem solving and reasoning

  3. Sydney psychosocial reintegration scale version 2 (SPRS-2)

    Time frame: 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)

  4. Satisfaction with life scale (SWLS)

    Time frame: 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

  5. Latrobe Communication Questionnaire (LCQ)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Moravian University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 26, 2022
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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