Lane ESD
Eugene, Oregon, 97401, United States
Location status: Recruiting
NCT Number: NCT07833917
RISE Lab: Building Resilience Through Responsibility Specific Aims
The goal of this pilot study is to develop, implement, and evaluate RISE Lab (Regulate, Identity, Strengthen, Empower), a small-group Tier 2 intervention that builds self-regulation, responsibility, and resilience among middle school students with behavioral and mental health needs. A two lesson, Cognitive Behavioral Therapy (CBT) aligned sequence on self-regulation from an employability social skills curriculum originally developed for justice-involved youth into a Tier 2 intervention for middle school students with behavioral and mental health needs. This project will accomplish the following aims:
Aim 1: Intervention Adaptation (development phase). This study will adapt a two lesson CBT-aligned sequence on Actions, Thoughts, and Feelings and Taking Responsibility into the RISE Lab intervention, designed for middle school students with behavioral and mental health needs. Content will be revised for developmental appropriateness and flexible delivery formats (push-in, pull-out, hybrid) and co-designed with relevant community members. This aim will address the following research questions:
1. How can lessons originally designed for justice-involved youth be adapted for middle school students with behavioral and mental health challenges? 2. What modifications (e.g., language, visuals, delivery format, context, lesson activities) make the lessons more engaging, accessible, and appropriate for middle school students? 3. What do teachers, counselors, parents, and students find most critical for ensuring feasibility in a school setting?
Aim 2: Pilot Study (implementation phase). Implement RISE Lab in 6-8 Tier 2 small groups of 4-5 students across two middle schools to assess feasibility, acceptability, and fidelity of implementation. Facilitators will receive training, and students will participate in a multi-session intervention cycle with opportunities for practice, reflection, and generalization. The following questions will be addressed:
1. Is RISE Lab feasible to deliver within a middle school MTSS framework without excluding students from general education instruction? 2. How acceptable do students, teachers, and school mental health staff find the intervention content, structure, and delivery? 3. Can RISE Lab be delivered with fidelity across different facilitators (e.g., counselor vs. SPED teacher) and formats (e.g., push-in vs. pull-out)?
Aim 3: Outcomes and Refinement (evaluation phase). Conduct a mixed-methods evaluation of RISE Lab to assess preliminary impacts on student mental health and behavioral outcomes (e.g., self-regulation, responsibility, and resilience) and to gather teacher, student, and family feedback on the intervention. Findings will be used to refine RISE Lab for scalability and readiness for larger-scale efficacy testing in future grants. This aim will address the following research questions:
1. Do students who participate in RISE Lab show improvements in self-regulation, responsibility, and resilience relative to baseline? 2. How do teachers perceive changes in participating students' classroom behaviors (e.g., emotional regulation, peer interactions, accountability)? 3. What does qualitative feedback from students, teachers, and parents suggest about refinement of RISE Lab for acceptability, feasibility, and implementation fidelity?
The primary outcome of RISE Lab is acceptability, feasibility, and fidelity of the intervention package with secondary outcomes of improved student self-regulation as measured by taking responsibility, resilience, and improvements in classroom behavior. Project outputs will include an adapted intervention with age-appropriate examples, worksheets, and visuals; a facilitator implementation guide with strategies for effective delivery; training materials; and a pilot feasibility report. Findings will provide the groundwork for a future efficacy trial and broader integration of RISE Lab within school-based MTSS.
Interested in participating?
Request Info11 year–14 year
All sexes
Interventional
Not applicable
Eugene, Oregon, 97401, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The goal of this pilot study is to develop, implement, and evaluate RISE Lab (Regulate, Identity, Strengthen, Empower), a small-group Tier 2 intervention that builds self-regulation, responsibility, and resilience among middle school students with behavioral and mental health needs. A two lesson, Cognitive Behavioral Therapy (CBT) aligned sequence on self-regulation from an employability social skills curriculum originally developed for justice-involved youth into a Tier 2 intervention for middle school students with behavioral and mental health needs.
Time frame: The AIM is administered to facilitators and students within 30 days of the conclusion of intervention implementation. This measure will be used through study completion, an average of one academic year.
The Acceptability of Intervention Measure (AIM) assesses the acceptability of the intervention from the perspective of facilitator and students. The measure has four items that are rated on a 5-point Likert-type scale from 1 (completely disagree) to 5 (completely agree). Higher scores indicate a more favorable outcomes.
Time frame: The IAM is administered to facilitators and students within 30 days of the conclusion of intervention implementation. This measure will be used through study completion, an average of one academic year.
The Intervention Appropriateness Measure (IAM) assesses the appropriateness of the intervention from the perspective of facilitator and students. The measure has four items that are rated on a 5-point Likert-type scale from 1 (completely disagree) to 5 (completely agree). Higher scores indicate a more favorable outcomes.
Time frame: The FIM is administered to facilitators and students within 30 days of the conclusion of intervention implementation. This measure will be used through study completion, an average of one academic year.
The Feasibility of Intervention Measure (FIM) assesses the feasibility of the intervention from the perspective of facilitator and students. The measure has four items that are rated on a 5-point Likert-type scale from 1 (completely disagree) to 5 (completely agree). Higher scores indicate a more favorable outcomes.
Contact information is provided by the study sponsor or research team.
University of Oregon
Other
Acronym: RISE Lab
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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