Menu
Enrolling by invitation NCT07749885

Emotion Regulation for Middle Schoolers

No phase Interventional Emotion Regulation Difficulties Risky Behaviors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iTRAC+, iTRAC.
Who it may be relevant to
Registry conditions: Emotion Regulation Difficulties, Risky Behaviors. Basic parameters: 10 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Detailed description

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.

Interventions

  • Behavioral iTRAC+
    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 in
  • Behavioral iTRAC
    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 outcome measures

  • Emotion Regulation Skill Use [Time frame: Baseline and 4 months post-intervention]
  • Difficulties in Emotion Regulation [Time frame: Time Frame: Baseline and 4 months post-intervention]
  • Emotional Self-Efficacy [Time frame: Baseline to 4 months post-intervention]
Secondary outcome measures (8)
  • Depression Symptoms [Time frame: Baseline to 4 months post intervention]
  • Generalized Anxiety Symptoms [Time frame: Baseline to 4 months post-intervention]
  • Strengths and Difficulties [Time frame: Baseline and 4 months post-intervention]
  • Teacher-Student Relationships [Time frame: Baseline and 4 months post-intervention]
  • Disciplinary actions in classroom [Time frame: Baseline and 4 months post-intervention]
  • Attendance [Time frame: Baseline and 4 months post-intervention]
  • School Connectedness [Time frame: Baseline and 4 months post-intervention]
  • Teacher Stress [Time frame: Baseline and 4 months post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Bethel School District_Middle Schools Only — Bethel
  • Springfield School District_Middle Schools Only — Springfield

Identifiers

NCT: NCT07749885 · STUDY00001762 · 1P50MH139449-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗