Lower Socioeconomic Background clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT03615937 Completed - Clinical trials for Lower Socioeconomic Background

KeySteps@JC - Early Child Intervention

KSJC

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The proposed early intervention is grounded within a framework that incorporates two key aspects: a multi-level component with nested or layered contexts, and a growth aspect with early and on-going social investments to mitigate disparate trajectories among underprivileged children. Capital is built across multiple levels over a three-year period during the critical window of early childhood - among the young children themselves plus their primary caregivers and teachers (Level 1), the family unit and school environment (Level 2), and the larger community (Level 3) that includes infrastructure for extended learning and bridges with other resource institutions. Schools will be stratified and then randomized to receive an integrated multi-disciplinary intervention or a health consultation control. Evaluation will include a comprehensive battery to assess baseline capacity in children, parents, teachers, relationship characteristics between them, as well as the early learning environment at home and at school (Year 1), repeated measures to index intermediate (ongoing for specific individual and family domains, 3 months for school changes, annual progress reports) and final response (Year 3) to treatment, and age- and time-appropriate (e.g. age 4, 5, 6; stage of parenting; experience of teachers) indices of functioning at each annual checkpoint.