- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07749885
Emotion Regulation for Middle Schoolers (iTRAC+)
Implementation and Evaluation of an Optimized Digital Emotion Regulation Program for Middle Schoolers
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Oregon
-
Bethel, Oregon, Spojené státy, 97402
- Bethel School District_Middle Schools Only
-
Springfield, Oregon, Spojené státy, 97477
- Springfield School District_Middle Schools Only
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Aktivní komparátor: 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.
|
|
Žádný zásah: Assessment Only
Receives no intervention during the study period but is offered access to the iTRAC program after study completion.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Emotion Regulation Skill Use
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Depression Symptoms
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00001762
- 1P50MH139449-01 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .