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Mental HealthRISE LabNCT07833917

RISE Lab: Building Resilience Through Responsibility

A study testing 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 people with Mental Health, run by University of Oregon at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 11 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Mental Health
What is being tested?
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.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
13 May 2026to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kyle Reardon, Ph.D contact

8025588689

kreardon@uoregon.edu

United States1 site, 1 recruiting
  • Lane ESD

    Eugene, Oregon, 97401

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

    Recruiting

Other trials in United States

About this study

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:

Read more

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.

Conditions
Mental Health
Being tested
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.
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.Behavioural

    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.

Study groups in NCT07833917
Study groupRoleWhat they receive
RISE LabExperimentalPrimary intervention
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start13 May 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07833917
Sponsor's protocol ID
RISELab
Other IDs
1P50MH139449-01
Acronym
RISE Lab
Status last verified
Mar 2026
First submitted
19 May 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 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 people with Mental Health, run by University of Oregon at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kyle Reardon, Ph.D (8025588689, kreardon@uoregon.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Intervention Measure (AIM) (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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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