NCT05517161

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

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

May 2, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

August 23, 2022

Last Update Submit

October 18, 2023

Conditions

Outcome Measures

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.

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

Secondary Outcomes (5)

  • Repeatable Battery for the Assessment of Neuropsychological Status Update

    During week 1 and week 10 of the 10 week protocol

  • Functional Assessment of Verbal Reasoning and Executive Strategies

    During week 1 and week 10 of the 10 week protocol

  • Sydney psychosocial reintegration scale version 2 (SPRS-2)

    During week 1 and week 10 of the 10 week protocol

  • Satisfaction with life scale (SWLS)

    During week 1 and week 10 of the 10 week protocol

  • Latrobe Communication Questionnaire (LCQ)

    During week 1 and week 10 of the 10 week protocol

Study Arms (1)

Individuals with TBI

Behavioral: INSIGHT

Interventions

INSIGHTBEHAVIORAL

See Keegan et al., 2020

Individuals with TBI

Eligibility Criteria

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

You may qualify if:

  • moderate to severe TBI more than 1 year ago

You may not qualify if:

  • other neurological diagnoses prior to TBI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moravian University

Bethlehem, Pennsylvania, 18018, United States

Location

MeSH Terms

Conditions

Social Communication Disorder

Condition Hierarchy (Ancestors)

Communication DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Louise C Keegan

    Moravian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor & Program Director of Speech-Language Pathology

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 26, 2022

Study Start

May 2, 2022

Primary Completion

December 20, 2022

Study Completion

May 1, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations