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Emotion Regulation for Middle Schoolers (iTRAC+)

2026년 8월 3일 업데이트: University of Oregon

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).

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

990

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Oregon
      • Bethel, Oregon, 미국, 97402
        • Bethel School District_Middle Schools Only
      • Springfield, Oregon, 미국, 97477
        • Springfield School District_Middle Schools Only

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  • Student participants must:

    1. Attend a participating middle school
    2. assent to participate
    3. Speak and read in English
  • Teacher participants must:

    1. Be teaching a relevant classroom in a participating middle school
    2. consent to participate
    3. Speak and read in English

Exclusion Criteria:

  • Adolescents will be excluded from the study if:

    1. They do not attend a standard classroom due to emotional or behavioral problems that require placement in a self-contained classroom
    2. Their caregivers do not consent to their participation

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: iTRAC+
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.
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.
활성 비교기: 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.
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.
간섭 없음: Assessment Only
Receives no intervention during the study period but is offered access to the iTRAC program after study completion.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Emotion Regulation Skill Use
기간: 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.
Baseline and 4 months post-intervention
Difficulties in Emotion Regulation
기간: 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.
Time Frame: Baseline and 4 months post-intervention
Emotional Self-Efficacy
기간: 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.
Baseline to 4 months post-intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Depression Symptoms
기간: 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.
Baseline to 4 months post intervention
Generalized Anxiety Symptoms
기간: 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.
Baseline to 4 months post-intervention
Strengths and Difficulties
기간: 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.
Baseline and 4 months post-intervention
Teacher-Student Relationships
기간: 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).
Baseline and 4 months post-intervention
Disciplinary actions in classroom
기간: 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.
Baseline and 4 months post-intervention
Attendance
기간: 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.
Baseline and 4 months post-intervention
School Connectedness
기간: 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.
Baseline and 4 months post-intervention
Teacher Stress
기간: 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.
Baseline and 4 months post-intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 3월 6일

기본 완료 (추정된)

2028년 2월 2일

연구 완료 (추정된)

2028년 3월 31일

연구 등록 날짜

최초 제출

2026년 7월 22일

QC 기준을 충족하는 최초 제출

2026년 8월 3일

처음 게시됨 (실제)

2026년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 3일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STUDY00001762
  • 1P50MH139449-01 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

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.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다