Feasibility of SUPPORT-TBI
From Isolation to Connection: A Dyadic Approach to Enhancing Health After TBI
2 other identifiers
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
June 4, 2026
May 1, 2026
1.6 years
May 22, 2026
June 1, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
HEAL Treatment Expectancy Short Form
6-item measure of intervention satisfaction with a 5-point Likert scale (range 6-30).
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Pittsburgh Rehabilitation Participation Scale
Measure of engagement in intervention sessions (range 1-6); administered each session and combined into an intervention-wide engagement score.
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
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.
Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Secondary Outcomes (3)
MOS Social Support Survey
Baseline, Post-intervention (12 weeks)
PROMIS Ability to Participate in Social Roles and Activities
Baseline, Post-intervention (12 weeks)
PROMIS-29
Baseline, Post-intervention (12 weeks)
Study Arms (1)
SUPPORT-TBI
EXPERIMENTALThis 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.
Interventions
This 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.
Eligibility Criteria
You may qualify if:
- 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
- Report low social support (score of less than 50 on the MOS Social Support Survey)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
Kersey J, Schwartz J, Connor LT, Stark S. Delphi study for the development of a dyadic social support intervention for people with traumatic brain injury. Disabil Health J. 2026 Apr;19(2):101978. doi: 10.1016/j.dhjo.2025.101978. Epub 2025 Nov 6.
PMID: 41207858BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Kersey, PhD, OTR/L
Washington University School of Medicine
Central Study Contacts
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
- Principal Investigator
Study Record Dates
First Submitted
May 22, 2026
First Posted
June 4, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
June 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be made available within 6 months of the end of the grant period and will remain available for a minimum of 10 years.
- Access Criteria
- There are no anticipated factors or limitations that will affect the access, distribution, or reuse of the de-identified scientific data generated by this proposal. Controlled access will not be used. The data that is shared will be shared by unrestricted download.
This study will produce feasibility data and clinical outcome data on 30 participants with brain injury and 30 support providers, comprising 30 total dyads who complete all research procedures together. Data collection will be performed at Washington University medical campus or community sites in and around St. Louis, MO. Session-level outcome data will include the patient-reported HEAL Treatment Expectancy short form, the HEAL Patient-Provider Connection short form, the Pittsburgh Rehabilitation Participation Scale, and our study-specific fidelity checklist. Intervention-level outcome data will include the Client Satisfaction Questionnaire-8, MOS Social Support Survey, PROMIS Ability to Participate in Social Roles and Activities, and PROMIS-29. Individual level processed data will be available for sharing.