An interventional study of RISE Lab is a tier 2 small group mental health intervention aimed at building self-regulation and resilience among middle school students at risk for mental health concerns. in Mental Health, sponsored by University of Oregon. Recruiting at 1 site in United States. Open to participants aged 11 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by University of Oregon · Not applicable, Interventional, and Prevention
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:
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:
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:
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.
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 30 is below the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University of Oregon is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
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Primary intervention
Behavioral: RISE Lab is a tier 2 small group mental health intervention aimed at building self-regulation and resilience among middle school students at risk for mental health concerns.
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.
Acceptability of Intervention Measure (AIM)
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 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.
Intervention Appropriateness Measure (IAM)
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 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.
Feasibility of Intervention Measure (FIM)
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.
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.
Plan to share: No
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Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 7 months is below that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
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University of Oregon