Recruiting

RISE Lab

Sponsor:

University of Oregon

Code:

NCT07833917

Conditions

Mental Health

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

Interventions

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.

Study Details

Brief 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.

Conditions

Mental Health

Study ID

NCT07833917

Start date

May 13, 2026

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

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:

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: RISE Lab

Primary intervention

Interventions

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.

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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Locations

Lane ESD

Recruiting

Eugene, Oregon, United States, 97401

Contacts

More Information

Sponsor

University of Oregon

Last update posted

Sep 22, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Oregon on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.