ENGAGE-TBI Feasibility Study

NCT07549997 | Not Yet Recruiting Phase 1

• 1 other identifier: 202503070
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

TBI (Traumatic Brain Injury)

Outcome Measures

Primary Outcomes (3)

• Client Satisfaction Questionnaire-8

  8-item measure of intervention satisfaction with a 4-point Likert scale (8-32); higher scores indicate greater satisfaction

  Post-Treatment (6-weeks)

• 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.

  Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)

• 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)

  Baseline, Post-Treatment (6-weeks)

Secondary Outcomes (2)

• PROMIS (Patient-Reported Outcome Measures Information System) Social Isolation

  Baseline, Post-Treatment (6-weeks)

• PROMIS-29 (Patient-Reported Outcome Measures Information System)

  Baseline, Post-Treatment (6-weeks)

Study Arms (1)

ENGAGE-TBI

EXPERIMENTAL

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.

Behavioral: Social intervention study for TBI survivors

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.

ENGAGE-TBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• American Occupational Therapy Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L

CONTACT

+1 314 273 7540; jkersey@wustl.edu

Curtis Comer, Clinical Research Coordinator I, High School

CONTACT

+1 314 273 3288; curtisccomer@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jessica Kersey, PhD, OTR/L Assistant Professor

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available six months after the end of the grant period and will be made available for a minimum of 10 years.
• Access Criteria: The dataset and data dictionary will be disseminated via the Washington University Research Data Repository, which is publicly available. Controlled access will not be used. The data that are shared will be shared by unrestricted download.

Locations

US (1)