ENGAGE-TBI Feasibility Study

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07549997
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Social intervention study for TBI survivors — BEHAVIORAL
    ENGAGE-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.

Study Details

This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ENGAGE-TBI
    The outcome measures for feasibility will be participant satisfaction (Client Satisfaction Questionnaire-8), intervention fidelity, engagement in intervention (Pittsburgh Rehabilitation Participation Scale), attendance rate, and retention rate.

Primary Outcome Measure

Client Satisfaction Questionnaire-8 [ Time Frame: Post-Treatment (6-weeks) ]

Central Contacts

  • Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L
    +1 314 273 7540
    [email protected]
  • Curtis Comer, Clinical Research Coordinator I, High School
    +1 314 273 3288
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L
[email protected]
+1 314 273 7540
Curtis Comer, Clinical Research Coordinator I, High School
[email protected]
Jessica Kersey, PhD, OTR/L, PhD, OTR/L (PRINCIPAL_INVESTIGATOR)

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