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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are evaluating a prevention-focused program aimed at reducing the harms of adverse childhood experiences (ACEs), substance use, and overdose in 36 New Jersey communities facing high rates of these issues. The study uses a cluster randomized controlled trial to compare the Strengthening Families Program (SFP) combined with Family Advocates (FAs) against the SFP alone. The research also includes assessments of implementation challenges and costs to determine the most effective and efficient way to support families affected by ACEs and substance use. The study involves two groups: one receiving the traditional Strengthening Families Program, which includes 11 sessions over 10 to 14 weeks, and the other receiving the same program with added support from trauma-informed Family Advocates. These advocates help families access community resources for substance use and ACE prevention and treatment. Families include parents or caregivers and youth aged 7 to 17. The interventions are delivered through group sessions following the SFP7-17 curriculum. Participants will be assessed at the start, at the end of the 10 to 14-week intervention, and again six months later. Assessments focus on substance use rates, perceptions of harm from substance use, and referrals to clinical and non-clinical services. Families must have access to technology like a computer or smartphone to participate. The study tracks progress and outcomes over these time points to understand the program's impact and sustainability in communities with high ACEs and substance use burdens.

Age: 7Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Age: 18Years +All Genders
2284 locations