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.
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.
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
Lane ESD
Eugene, Oregon, 97401
Kyle Reardon, Ph.D., 8025588689, kreardon@uoregon.edu
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:
- How can lessons originally designed for justice-involved youth be adapted for middle school students with behavioral and mental health challenges?
- What modifications (e.g., language, visuals, delivery format, context, lesson activities) make the lessons more engaging, accessible, and appropriate for middle school students?
- 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:
- Is RISE Lab feasible to deliver within a middle school MTSS framework without excluding students from general education instruction?
- How acceptable do students, teachers, and school mental health staff find the intervention content, structure, and delivery?
- 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:
- Do students who participate in RISE Lab show improvements in self-regulation, responsibility, and resilience relative to baseline?
- How do teachers perceive changes in participating students' classroom behaviors (e.g., emotional regulation, peer interactions, accountability)?
- 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 group | Role | What they receive |
|---|---|---|
| RISE Lab | Experimental | Primary 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.
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.
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.
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.
- First posted22 Sep 2026
- Study start13 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RISE Lab: Building Resilience Through Responsibility
- ClinicalTrials.gov ID
- NCT07833917
- Acronym / sponsor ID
- RISE Lab / RISELab
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How can lessons originally designed for justice-involved youth be adapted for middle school students with behavioral and mental health challenges?
- What modifications (e.g., language, visuals, delivery format, context, lesson activities) make the lessons more engaging, accessible, and appropriate for middle school students?
- 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:
- Is RISE Lab feasible to deliver within a middle school MTSS framework without excluding students from general education instruction?
- How acceptable do students, teachers, and school mental health staff find the intervention content, structure, and delivery?
- 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:
- Do students who participate in RISE Lab show improvements in self-regulation, responsibility, and resilience relative to baseline?
- How do teachers perceive changes in participating students' classroom behaviors (e.g., emotional regulation, peer interactions, accountability)?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RISE Lab | Experimental | 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.Primary intervention |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Enrolled in partner middle schools; identified by MTSS/PBIS teams for Tier 2 supports (behavior data); parental consent and student assent obtained.
Key exclusion criteria (1 listed)
- Receiving Tier 3 or clinical mental health services; unable to participate in small-group sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | RISE Lab |
Primary outcome
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 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.
Intervention Appropriateness Measure (IAM)
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.
Feasibility of Intervention Measure (FIM)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.