Health TrialsbyHealthPanel

ENGAGE-TBI Feasibility Study

ConditionTBI (Traumatic Brain Injury)
Trial statusRecruiting
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 volunteers

Qualifiers

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

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group 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)

Other outcomes

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
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