Social Intervention for TBI

Overseen By Curtis Comer, Clinical Research Coordinator I, High School

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Disqualifiers: Substance use disorder, Untreated psychotic disorder, Severe memory impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

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)

Exclusion Criteria

Active substance use disorder (PRIME-MD MINI)

Untreated psychotic disorder (PRIME-MD MINI)

Insufficient English language fluency to participate in the group intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ENGAGE-TBI intervention, a 12-session group intervention over six weeks, focusing on social learning, guided problem-solving, and skilled community practice.

6 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for social participation and satisfaction post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ENGAGE-TBI

How Is the Trial Designed?

Group I: ENGAGE-TBI Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

American Occupational Therapy Foundation

Collaborator

Trials

14

Recruited

380+