Search Bar & Filters
Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating a prevention-based intervention aimed at reducing the harms of adverse childhood experiences ACEs and preventing future ACEs, substance use, and overdose in 36 communities facing high rates of these issues. This study uses a cluster randomized controlled trial to compare the Strengthening Families Program SFP combined with Family Advocates FAs versus SFP alone. The research also explores factors affecting implementation and examines the costs and cost-effectiveness of the combined intervention, providing guidance to better support affected communities. The study compares two groups one receiving the SFP with additional support from trauma-informed, clinically trained Family Advocates who assist families in accessing community resources, and a control group receiving only the SFP curriculum. Both groups participate in the SFP7-17 program, which includes 11 sessions over 10 to 14 weeks. Family Advocates engage weekly with families in the treatment group through 1-hour post-session check-ins, including phone calls and service referrals, running alongside the SFP sessions. Participants include families with one or more adult caregivers and adolescents aged 7 to 17 from designated communities. The study involves baseline assessments, intervention completion evaluations 10 to 14 weeks, and follow-ups at 6 months post-intervention. Researchers measure substance use prevalence, perceptions of harm, referrals to clinical and non-clinical services, ACEs prevalence, social needs, substance use risk, system linkages, and costs. Families must have access to technology for participation, and ongoing monitoring ensures adherence and data collection throughout the study period.
Actively Recruiting
Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.