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Emotion Regulation DifficultiesiTRAC+NCT07749885

Emotion Regulation for Middle Schoolers

A study testing iTRAC+ and iTRAC in people with Emotion Regulation Difficulties and Risky Behaviors, run by University of Oregon at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 10 to 15 yearsHealthy volunteers can take part
What is being tested?
iTRAC+ and iTRAC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
990 participants
Where
2 sitesUnited States
Study dates
6 Mar 2026to 31 Mar 2028
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 10 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites
  • Bethel School District_Middle Schools Only

    Bethel, Oregon, 97402

  • Springfield School District_Middle Schools Only

    Springfield, Oregon, 97477

Other trials in United States

About this study

Official title: Implementation and Evaluation of an Optimized Digital Emotion Regulation Program 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).

Read the 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.

Being tested
iTRAC+, iTRAC
Keywords
Emotion Regulation
Medical subject headings
Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iTRAC+Behavioural

    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.

  • iTRACBehavioural

    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.

Study groups in NCT07749885
Study groupRoleWhat they receive
iTRAC+ExperimentaliTRAC+ 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.
Receives: Behavioral: iTRAC+
iTRACActive comparatoriTRAC 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.
Receives: Behavioral: iTRAC
Assessment OnlyNo interventionReceives no intervention during the study period but is offered access to the iTRAC program after study completion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 4 months post-intervention

  2. 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.

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

  3. 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.

    Measured: Baseline to 4 months post-intervention

Secondary outcomes (8)
  1. 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.

    Measured: Baseline to 4 months post intervention

  2. 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.

    Measured: Baseline to 4 months post-intervention

  3. 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.

    Measured: Baseline and 4 months post-intervention

  4. 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).

    Measured: Baseline and 4 months post-intervention

  5. 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.

    Measured: Baseline and 4 months post-intervention

  6. Attendance

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

    Measured: Baseline and 4 months post-intervention

  7. 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.

    Measured: Baseline and 4 months post-intervention

  8. 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.

    Measured: Baseline and 4 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start6 Mar 2026
  3. Primary completion2 Feb 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The iTRAC (Talking about Risk and Adolescent Choices), iTRAC+, and assessment-only control conditions are compared across an 8-week period embedded within the regular school day. 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. iTRAC+ integrates this same digital 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. The assessment-only control condition receives no intervention during the study period but is offered access to the iTRAC program after study completion.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
990 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07749885
Sponsor's protocol ID
STUDY00001762
Other IDs
1P50MH139449-01
Acronym
iTRAC+
Status last verified
Jul 2026
First submitted
22 Jul 2026
Last updated
6 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing iTRAC+ and iTRAC in people with Emotion Regulation Difficulties and Risky Behaviors, run by University of Oregon at 2 sites 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 8 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotion Regulation Skill Use (time frame: Baseline and 4 months post-intervention). 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 6 Aug 2026.

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