An interventional study of iTRAC+ and iTRAC in Emotion Regulation Difficulties and Risky Behaviors, sponsored by University of Oregon. Enrolling by invitation at 2 sites in United States. Open to participants aged 10 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by University of Oregon · Not applicable, Interventional, and Treatment
Early adolescence (ages 11-14) is a key developmental period repeatedly coupled with the onset of mental health problems. Middle schools provide a naturalistic setting in which to implement programming to prevent the development of more significant mental health problems. School-based social-emotional learning (SEL) programs have previously filled this gap and have demonstrated impact on social and emotional skills, attitudes, behaviors, and academic performance. Across SEL programs, emotion regulation (ER) has been identified as a primary component that impacts important mental health and school outcomes. ER, a transdiagnostic correlate of mental health, is the set of processes used to manage feelings and their expression to achieve goals. Among middle schoolers, greater use of ER strategies has been found to protect against negative social effects and poorer mental health. Among SEL programs for middle school students, none have examined the impact on ER or mental health outcomes beyond conduct problems, and many fail to provide adequate training and support to their key implementers, teachers. Implementation is also often hampered by time- and resource-intensive delivery schedules. For these reasons, incorporating brief ER skill-building programs using a digital health model into middle schools that includes teacher training to support learning can reduce mental health concerns and promote school functioning. We propose to optimize a brief, validated, digitally delivered ER intervention (iTRAC; Talking about Risk and Adolescent Choices) to include a teacher component that can be delivered within middle schools. This will improve upon the rigor of our pilot research by implementing the program during the regular school day and developing a complementary teacher program to enhance the uptake of the digitally delivered student-facing program hereafter referenced as iTRAC+. iTRAC+ will be evaluated on implementation outcomes and impact on ER abilities among middle schoolers and teachers. The current study will be carried out across implementation Steps 1-3 and will be guided by the Advancing Children's Connection, Emotion Regulation, and School Support (ACCESS) Center implementation framework. In Step 1, we will work with an expert panel and community partners to develop the classroom and teacher components and identify strategies to enhance teacher and school engagement with the program before advancing to the next step. In Step 2, we will evaluate the initial acceptability and feasibility of the expanded iTRAC+ program with four classrooms for further refinement of teacher training materials, teacher recruitment plans, and the classroom delivery schedule. During Step 3, we will randomize 46 classrooms from four middle schools to receive either iTRAC+ or an attention control condition to examine the preliminary impact on mechanisms and outcomes. Students and teachers will be assessed prior to randomization and 4 months after program implementation. This schedule will permit short-term evaluation of the iTRAC+ program and identify barriers and enhancers to future implementation of the program to be assessed within a fully powered implementation trial (R01).
This study is a multi-phase implementation-optimization project guided by the ACCESS Center and the Consolidated Framework for Implementation Research (CFIR), unfolding across three sequential steps over approximately 36 months and culminating in a randomized pilot effectiveness trial. In the final step, classrooms and schools are randomly assigned, using a stratified allocation procedure, to one of three conditions: iTRAC+ (the digital emotion-regulation program paired with teacher training and classroom activities), iTRAC alone (the digital program only), or assessment-only control. Findings from this work are intended to inform a future, fully powered R01 implementation trial.
The intervention itself centers on iTRAC, a self-guided digital emotion-regulation (ER) skill-building program delivered via school-provided tablets or laptops. Its four modules are split into eight shorter segments, each 15-20 minutes long, delivered once weekly for up to 12 weeks. In the enhanced iTRAC+ arm, teachers receive additional training (kept under four hours, delivered in person and through asynchronous video) and lead classroom activities-such as small-group "emotion generator" games-after each digital module, reinforcing ER concepts through modeling, scaffolding, and praise. Both versions are embedded directly into the regular school day rather than delivered after school.
The rationale for the study rests on the idea that emotion regulation is a transdiagnostic mechanism tied to adolescent mental health, school functioning, and long-term adjustment, yet few evidence-based social-emotional learning programs specifically target ER, and teacher-focused ER training is often overlooked entirely. The original iTRAC program already demonstrated moderate effects (d = .44-.49) on ER outcomes along with strong feasibility and acceptability. Adding a teacher-training "coaching" layer is expected to strengthen uptake and durability of the digital content, addressing well-documented barriers to school-based intervention implementation such as cost, fidelity, and limited school resources.
Recruitment draws from public middle schools across school districts in Oregon. Step 1 recruits an eight-member Expert Panel of administrators, counselors, and teachers through district-level meetings to inform iterative qualitative interviews conducted across up to five rounds. Step 2 involves four to six classrooms from a single middle school, with teachers self-selecting into the project through faculty meetings and recruitment emails. Step 3 expands to six middle schools, enrolling 48 classroom teachers (16 per condition) and roughly 864 students, recruited with the help of school "champions," flyers with QR codes, and staff meetings. Consent follows a passive model for parents-opt-out letters and emails sent across two rounds over four weeks-combined with active student assent and active consent from teachers and administrators.
Assessment procedures scale up across the three steps. Step 1 relies solely on qualitative data: audiotaped and transcribed Expert Panel interviews of about an hour each, analyzed thematically through matrix displays and refined with input from the Community Partners and Advisors Committee. Step 2 adds baseline-only questionnaires for students (two 30-minute sessions) and teachers (about 60 minutes), administered via Qualtrics, along with post-intervention teacher feedback interviews. Step 3 introduces a full baseline and 4-month post-intervention assessment for both students and teachers across all three conditions, supplemented by brief acceptability and usability surveys for iTRAC+ participants, classroom observations (sampling 25% of sessions), and teacher-completed fidelity forms.
Evaluation is organized around the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and CFIR domains. Reach and adoption are captured through enrollment rates, demographic representativeness, and program completion; implementation is assessed via classroom observations and fidelity ratings covering activity occurrence, competence, and time allocation; effectiveness is measured through both proximal mechanisms (ER abilities) and distal outcomes (mental health, student-teacher relationships, school connectedness, and disciplinary actions); and maintenance is explicitly excluded from the current project's scope.
Analytically, Steps 1 and 2 rely on qualitative matrix and thematic analysis to guide iterative refinement of the program, while Step 2's feasibility is judged against benchmarks of at least 70% enrollment, greater than 75% completion, and at least 80% fidelity. The pilot trial in Step 3 uses a 3-group by 2-time (pre/post) design, analyzed with linear mixed models or analysis of covariance (ANCOVA) that account for student clustering within classrooms. The study is powered at .80-.83 to detect small-to-moderate effects-approximately d = .38-.40 at the student level and d = .557 at the teacher level-based on 48 classrooms and roughly 734 students expected to have complete follow-up data.
545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.
This study's planned enrollment of 990 is above the median of 79 across 498 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →University of Oregon is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
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Student participants must:
Teacher participants must:
Exclusion Criteria:
Adolescents will be excluded from the study if:
iTRAC+ integrates iTRAC curriculum with a complementary teacher-training and classroom-activity component, in which teachers are trained to model, scaffold, and reinforce ER skills through structured in-class discussions and activities following each digital module.
Behavioral: iTRAC+
iTRAC is a self-guided digital emotion regulation (ER) program delivered via tablet or laptop, teaching students to identify, label, and manage feelings through interactive modules.
Behavioral: iTRAC
Receives no intervention during the study period but is offered access to the iTRAC program after study completion.
Digital emotion regulation skill-building intervention paired with teacher training and classroom-based reinforcement activities. Intervention components will be delivered through up to 3 hours of digital content across up to 12 weeks (15-20 minute modules, once weekly), preceded by up to 4 hours of teacher training and supplemented by teacher-led classroom activities following each digital module. All students will be assessed prior to randomization (baseline) and 4 months after the start of intervention.
Self-guided digital emotion regulation skill-building intervention delivered independently by students on school-provided tablets or laptops. Intervention components will be delivered in about 3 hours of digital content over up to 12 weeks. All students will be assessed prior to randomization (baseline) and 4 months after the start of intervention.
Emotion Regulation Skill Use
Completed by both students and teachers, the Emotion Regulation Behavior Scale (ERBS; 9 items) assesses the use of specific emotion regulation strategies taught within the iTRAC program. Participants rank each item/strategy from 1 (never) to 4 (often). Scores range between 9 and 36, with higher scores indicating greater use of emotion regulation strategies.
Time frame: Baseline and 4 months post-intervention
Difficulties in Emotion Regulation
Completed by both students and teachers, the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF; 18 items) assesses overall emotion regulation use across multiple domains (strategies, non-acceptance, impulse, goals, awareness, and clarity) on a 5-point scale (from 1, never, to 5, always). Scores range from 18-90, with higher scores indicating greater difficulty with emotion regulation.
Time frame: Time Frame: Baseline and 4 months post-intervention
Emotional Self-Efficacy
Completed by both students and teachers, the Self-Efficacy Questionnaire for Children (SEQ-C; 8 items) emotional self-efficacy subscale assesses confidence in one's ability to manage and cope with emotional states. Participants rank each item from 1 (not at all) to 5 (very well), and receive a score within the range of 8-40. Higher scores indicate greater confidence in emotional coping abilities.
Time frame: Baseline to 4 months post-intervention
Depression Symptoms
Completed by students only, depression symptoms will be measured by the Patient Health Questionnaire-8 (PHQ-8; 8 items). Participants rank items from 0 (not at all) to (3) nearly every day. Scores range from 0 to 21, with higher scores indicating greater depression symptoms.
Time frame: Baseline to 4 months post intervention
Generalized Anxiety Symptoms
Completed by students only, generalized anxiety symptoms will be measured by the Generalized Anxiety Disorder-7 (GAD-7; 7 items). Participants rank items from 0 (not at all) to (3) nearly every day. Scores range from 0 to 21, with higher scores indicating greater generalized anxiety symptoms.
Time frame: Baseline to 4 months post-intervention
Strengths and Difficulties
Completed by students only, emotional symptoms, conduct problems, and hyperactivity are assessed using the Strengths and Difficulties Questionnaire (SDQ; 25 items). Participants rank items from 0 (not true) to 2 (certainly true). Scores range from 0 to 50, with higher scores indicating greater distress or behavior challenges.
Time frame: Baseline and 4 months post-intervention
Teacher-Student Relationships
Completed by students, the Teacher-Student Relationship Inventory-Student Version (S-TSRI; 14 items) assesses students' relationships to their teachers. Participants rank items from 1 (almost never true) to 5 (almost always true). Scores range from 14 to 70, with higher scores reflecting higher levels of specific relational dimensions (i.e., satisfaction, perceived instrumental help, or conflict).
Time frame: Baseline and 4 months post-intervention
Disciplinary actions in classroom
Disciplinary actions in the classroom are obtained from school records and reflect the number and type of disciplinary incidents recorded for participating students.
Time frame: Baseline and 4 months post-intervention
Attendance
Student attendance is obtained from school records and reflects the number of days present versus absent across the academic term.
Time frame: Baseline and 4 months post-intervention
School Connectedness
Completed by students only, school connectedness is assessed using a self-report school climate survey from the Center on Positive Behavioral Interventions and Supports (PBIS). This scale contains 27 items measuring students' sense of belonging, safety, and engagement within their school environment. Scores range from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating greater school connectedness.
Time frame: Baseline and 4 months post-intervention
Teacher Stress
Completed by teachers only, teacher stress is assessed using the self-report Perceived Stress Scale (PSS; 10 items), which measures the degree to which situations in one's life are appraised as stressful. Participants rank each item from 0 (never) to 4 (very often). Scores reange from 0 to 40, with higher scores indicating higher perceived stress.
Time frame: Baseline and 4 months post-intervention
Plan to share: Yes — De-identified, final research data generated in the research activities, along with metadata, descriptors, and protocols, will be shared with the broader scientific community. Materials to be shared include detailed protocols and recommendations for schools to improve the health and well-being of middle schoolers. Researchers outside of the ACCESS Center will have access to a standard de-identified, individual-level dataset held to the same standard as that established by the HIPAA Privacy Rule. General documentation will be available without cost in the form of PDF files. Potentially identifying fields as defined in the HIPAA Privacy Rule will not be released to outside researchers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: After completion of the project funding period, de-identified, final research data generated in the research activities, along with metadata, descriptors, and protocols, will be shared with the broader scientific community through dissemination efforts and uploads to the NIMH Data Archive.
Access criteria: External researchers' requests for de-identified individual-level data must be accompanied by a signed Data Use Agreement, and researchers must document that they are working under an institution with a Federal Wide Assurance (FWA). To optimize usage of the data, the website at the University of Oregon's ACCESS Center will provide clear instructions for accessing the data.
Data sharing details ↗ · blogs.uoregon.edu
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Feb 2028, 22 months after the start.
Of 390 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 22 months is above that.
Counting every sponsor, half of 396 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
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