Feasibility of SUPPORT-TBI
ConditionTBI Traumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
Many people who have had a traumatic brain injury (TBI) struggle to stay connected with others. They often lose friendships, become isolated, and have strained family relationships. This lack of social support is linked to worse physical and mental health, lower quality of life, and even a shorter lifespan. The investigators developed a program where a person with TBI and one close supporter work together with a therapist over 12 weekly sessions. They learn skills in communication, setting shared goals, supporting each other emotionally, and problem-solving, with occasional guidance from a peer mentor who has been through a similar experience. This study will determine whether the program is practical to deliver. We are conducting a pilot study with 30 pairs of participants to test whether sessions run smoothly, whether people show up and stay engaged, and whether participants find the program worthwhile. Based on what they learn, the investigators will refine this program before testing it on a larger scale. If successful, this could lead to a practical, low-risk intervention that improves the lives of people with TBI and the family members and friends who support them.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Live in a community setting (not an institutional setting)
Sustained a traumatic brain injury more than 6 months prior to enrollment
Report mild-moderate TBI-related disability (score of 5 or greater) on the Glasgow Outcome Scale - Extended
Disqualifiers
Insufficient English language fluency
Active substance use disorder (meets diagnostic criteria on the PRIME-MD MINI alcohol or non-alcoholic substances modules)
Active, untreated psychotic disorder (meets diagnostic criteria on the PRIME-MD MINI psychotic disorders module)
Severe memory impairment (score of less than 21 on the Montreal Cognitive Assessment)
Trial design
Design model
Single group
Treatments tested in this trial
SUPPORT-TBI
BehavioralThis novel dyadic intervention incorporates essential elements of communication strategies, shared goals and activities, psychosocial support, peer mentorship, and problem-solving. The person with TBI and a close supporter complete intervention procedures together and work to develop sustainable strategies for an effective support relationship. The intervention is delivered in weekly 1-hour sessions for 12 consecutive weeks.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: SUPPORT-TBIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
HEAL Treatment Expectancy Short Form
6-item measure of intervention satisfaction with a 5-point Likert scale (range 6-30).
Time frame
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)2
Pittsburgh Rehabilitation Participation Scale
Measure of engagement in intervention sessions (range 1-6); administered each session and combined into an intervention-wide engagement score.
Time frame
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)3
Study-specific fidelity checklist
Checklist measuring the percentage of adherence to the outlined intervention elements; administered each session and combined into an intervention-wide adherence rate.
Time frame
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)Secondary outcomes
1
MOS Social Support Survey
19-item questionnaire examining perceived social support on a 5-point Likert scale with transformed scores (0-100).
Time frame
Baseline, Post-intervention (12 weeks)2
PROMIS Ability to Participate in Social Roles and Activities
Computer adaptive test examining social participation abilities; scores reported as T-scores.
Time frame
Baseline, Post-intervention (12 weeks)3
PROMIS-29
29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores.
Time frame
Baseline, Post-intervention (12 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov