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RecruitingNCT07833917RISE LabUpdated Sep 22, 2026

RISE Lab: Building Resilience Through Responsibility

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

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
11 Years to 14 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Mental Health
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In context

Psychological Well-Being

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 →

Lead sponsor

University of Oregon is the lead sponsor of 75 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Enrolled in partner middle schools; identified by MTSS/PBIS teams for Tier 2 supports (behavior data); parental consent and student assent obtained.

Exclusion criteria

Exclusion Criteria:

  • Receiving Tier 3 or clinical mental health services; unable to participate in small-group sessions.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    RISE Lab

    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.

Interventions

  • BehavioralRISE 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.

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

07

Study locations

1 of 1 sites recruiting
  • Lane ESD
    Eugene, Oregon 97401, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2026
First posted
Sep 22, 2026
StartActual
May 13, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Mar 31, 2027
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07833917
Lead sponsor
University of Oregon
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
May 13, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Kyle Reardon, Ph.D
Contact
kreardon@uoregon.edu
8025588689

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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