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Safe@Home Intervention Group for Traumatic Brain Injury

Phase 2
Waitlist Available
Led By Ronald T. Seel, PhD
Research Sponsored by Shepherd Center, Atlanta GA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline)
Awards & highlights
No Placebo-Only Group

Summary

People who sustain moderate to severe traumatic brain injury (TBI) have an increased risk for unintentional injury and harm when resuming day to day activities in the home and community. People who sustain brain injuries primarily want to independently do the activities they enjoy while families primarily focus on avoiding injury or other harm events. Safe@Home is an injury prevention education and activity training program. Participants who have sustained a moderate or severe TBI receive a personalized strengths and safety risk assessment, tailored injury prevention education, and in-home training with a transition coach on self-selected activities. This study will evaluate whether the Safe@Home program reduces injuries and harm and increases clients' independence in their everyday activities in the home and community compared to a usual care control group.

Eligible Conditions
  • Traumatic Brain Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Carrying Out Activities Scale Score
Change in Mayo-Portland Participation Scale Score
Change in Supervision Rating Scale Score
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Safe@Home Intervention GroupExperimental Treatment1 Intervention
Participants receive: (1) computer-generated, personalized assessment of abilities, risk, and recommended next steps; (2) 2 person-family education visits to develop a shared understanding of client strengths and risks, set goals, develop better ways to work as a team, and problem-solve; (3) 8 in-home visits in which personal transition trainer/life skills coach provides training, compensatory strategies, and social/technological supports on self-selected activities. The ten visits last 90-120 minutes and ideally take place over a three month period.
Group II: Usual Care GroupActive Control1 Intervention
Participants receive the computer-generated, personalized assessment of abilities, risk, and recommended next steps. Participants may seek services as usual over the 3-month period.

Find a Location

Who is running the clinical trial?

Shepherd Center, Atlanta GALead Sponsor
29 Previous Clinical Trials
3,951 Total Patients Enrolled
Ronald T. Seel, PhDPrincipal InvestigatorShepherd Center, Atlanta GA
~6 spots leftby Nov 2025