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Child Behavior Disorders 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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Enrolling by invitation
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NCT ID: NCT05179759 Enrolling by invitation - Clinical trials for Child Behavior Disorders

Teachers Leading the Frontlines (Tealeaf) - a Hybrid Effectiveness, Implement, and Context Trial

Tealeaf

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Purpose: The primary aim of this research is to evaluate the effectiveness of teacher-delivered transdiagnostic mental healthcare for school-aged children in resource-limited primary schools. Participants: Within 60 rural, low-cost private primary schools of the Darjeeling Himalayas, all teachers meeting eligibility criteria will be invited to participate in training and the intervention. The number of teachers consented and enrolled into the study will be determined by the size of the school. The number of students nominated by a teacher is at their discretion (including an option to not nominate any student in a given year if they do not perceive any of the student's to be appropriate for the intervention) However, based on the research team's pilot data and prior experience, teachers will be provided with the suggestion that they nominate two children to receive targeted intervention. For each child receiving intervention, a paired parent or guardian will be recruited and enrolled to the study. Procedures (methods): Effectiveness will be evaluated through a stepped-wedge cluster randomized controlled trial (SW-CRCT) with an embedded mixed methods evaluation of implementation and qualitative study of context (guided by the RE-AIM framework). Year 1 will include 60 schools in the control arm, year 2 will include 40 schools in the control arm and 20 in the intervention arm, year 3 will include 20 schools in the control arm and 40 in the intervention arm, and year 4 will include 60 schools in the intervention arm.