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CompletedNCT05517161Updated Oct 23, 2023

Roll for Intervention - TBI Group Treatment

An observational study in Communication Disorder, Social, sponsored by Moravian University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Moravian University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
5
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Communication Disorder, Social
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In context

Communication Disorders

124 studies on the registry are indexed under Communication Disorders; 41 are open to participants now.

This study's enrollment of 5 is below the median of 55 across 22 observational studies indexed under Communication Disorders.

Browse Communication Disorders studies →

Lead sponsor

Moravian University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

Inclusion criteria

  • moderate to severe TBI more than 1 year ago

Exclusion criteria

Exclusion Criteria:

  • other neurological diagnoses prior to TBI
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No

Groups and cohorts

  • Individuals with TBI

    Behavioral: INSIGHT

Interventions

  • BehavioralINSIGHT

    See Keegan et al., 2020

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What researchers measure

Primary outcomes

  1. Goal Attainament Scaling - change over time

    Assessing change over time on five point scaled goals - goal rated each week for 8 weeks.

    Time frame: Week 2, 3,4,5,6,7, 8 and 9 of the 10week study protocol

Secondary outcomes

  1. Repeatable Battery for the Assessment of Neuropsychological Status Update

    Randolf (2012) standardized norm referenced assessment measure of cognitive skills (memory and attention etc.)

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

  2. Functional Assessment of Verbal Reasoning and Executive Strategies

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

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

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

    Tate (2012) standardized likert based questionnaire (12, 1-5 ratings, where higher scores = better performance)

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

  4. Satisfaction with life scale (SWLS)

    Diener et al (1985), likert measurement scale questionnaire, 5 1-7 ratings, higher scores = better performance

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

  5. Latrobe Communication Questionnaire (LCQ)

    Douglas et al (2000), likert measurement scale questionnaire, 30 1-4 ratings, higher scores = better performance

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

07

Study locations

1 site
  • Moravian University
    Bethlehem, Pennsylvania 18018, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05517161
Lead sponsor
Moravian University
Responsible party
Louise Keegan (Associate Professor & Program Director of Speech-Language Pathology, Moravian University) — Principal investigator
First posted
Aug 26, 2022
Start date
May 2, 2022
Primary completion
Dec 20, 2022
Completion
May 1, 2023
Last update
Oct 23, 2023

Study contacts

Louise C Keegan
principal investigator · Moravian University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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