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NCT Number: NCT07749885

Emotion Regulation for Middle Schoolers

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).

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Key information

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bethel School District_Middle Schools Only, Bethel, Oregon, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Student participants must:
  • Attend a participating middle school
  • assent to participate
  • Speak and read in English
  • Teacher participants must:
  • Be teaching a relevant classroom in a participating middle school
  • consent to participate
  • Speak and read in English

Exclusion criteria

  • Adolescents will be excluded from the study if:
  • They do not attend a standard classroom due to emotional or behavioral problems that require placement in a self-contained classroom
  • Their caregivers do not consent to their participation

Treatment and study plan

iTRAC+

Behavioral

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.

iTRAC

Behavioral

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.

Primary outcomes

  1. Emotion Regulation Skill Use

    Time frame: Baseline and 4 months post-intervention

    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.

  2. Difficulties in Emotion Regulation

    Time frame: Time Frame: Baseline and 4 months post-intervention

    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.

  3. Emotional Self-Efficacy

    Time frame: Baseline to 4 months post-intervention

    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.

Secondary outcomes

  1. Depression Symptoms

    Time frame: Baseline to 4 months post intervention

    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.

  2. Generalized Anxiety Symptoms

    Time frame: Baseline to 4 months post-intervention

    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.

  3. Strengths and Difficulties

    Time frame: Baseline and 4 months post-intervention

    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.

  4. Teacher-Student Relationships

    Time frame: Baseline and 4 months post-intervention

    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).

  5. Disciplinary actions in classroom

    Time frame: Baseline and 4 months post-intervention

    Disciplinary actions in the classroom are obtained from school records and reflect the number and type of disciplinary incidents recorded for participating students.

  6. Attendance

    Time frame: Baseline and 4 months post-intervention

    Student attendance is obtained from school records and reflects the number of days present versus absent across the academic term.

  7. School Connectedness

    Time frame: Baseline and 4 months post-intervention

    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.

  8. Teacher Stress

    Time frame: Baseline and 4 months post-intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Implementation and Evaluation of an Optimized Digital Emotion Regulation Program for Middle Schoolers

Acronym: iTRAC+

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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