ENGAGE-TBI Feasibility Study
ConditionTBI (Traumatic Brain Injury)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
at least 18 years old
experienced a TBI > 6 months prior to enrollment, confirmed by a physician as documented in their medical record
live in the St. Louis area
report problems with social participation (retention of < 80% of pre-TBI social activities as measured by Activity Card Sort)
Disqualifiers
insufficient English language fluency to participate in the group intervention
have active substance use disorder (PRIME-MD MINI)
have an untreated psychotic disorder (PRIME-MD MINI)
have severe memory impairment that would limit their ability to recall strategies with support (Montreal Cognitive Assessment, < 21)
Trial design
Design model
Single group
Treatments tested in this trial
Social intervention study for TBI survivors
BehavioralENGAGE-TBI is a community-based group intervention that is co-facilitated by an occupational therapist and a person with a brain injury. ENGAGE-TBI incorporates social learning, guided problem-solving, and skilled practice of strategies to achieve social participation goals. It is delivered in 12 90-minute group sessions that are held twice per week for 6 weeks. Aside from community outings, sessions will take place at the Brain Injury Association of Missouri on a separate day and time from education group sessions.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: ENGAGE-TBIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Client Satisfaction Questionnaire-8
8-item measure of intervention satisfaction with a 4-point Likert scale (8-32); higher scores indicate greater satisfaction
Time frame
Post-Treatment (6-weeks)2
Pittsburgh Rehabilitation Participation Scale
Interventionist-administered measure of engagement in each intervention session; reported on a 1-6 scale, with higher scores indicating greater participation.
Time frame
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)3
PROMIS (Patient-Reported Outcome Measures Information System) Ability to Participate in Social Roles and Activities
Computer adaptive test examining social participation abilities; scores reported as T-scores (0-100 scale, with higher scores indicating greater participation)
Time frame
Baseline, Post-Treatment (6-weeks)Secondary outcomes
1
PROMIS (Patient-Reported Outcome Measures Information System) Social Isolation
Computer Adaptive Test examining social isolation; scores reported as T-scores (0-100 scale, higher scores indicate higher isolation)
Time frame
Baseline, Post-Treatment (6-weeks)2
PROMIS-29 (Patient-Reported Outcome Measures Information System)
29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores (0-100 scale, lower scores indicate greater health)
Time frame
Baseline, Post-Treatment (6-weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
American Occupational Therapy Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: