Implementation and Evaluation of an Optimized Digital Emotion Regulation Program for Middle Schoolers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 990
- 试验地点
- 2
- 主要终点
- Emotion Regulation Skill Use
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: iTRAC+ (Behavioral)
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.
干预措施: iTRAC (Behavioral)
Assessment Only
Receives no intervention during the study period but is offered access to the iTRAC program after study completion.
结局指标
主要结局
Emotion Regulation Skill Use
时间窗: 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.
Difficulties in Emotion Regulation
时间窗: 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.
Emotional Self-Efficacy
时间窗: 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.
次要结局
- Depression Symptoms(Baseline to 4 months post intervention)
- Generalized Anxiety Symptoms(Baseline to 4 months post-intervention)
- Strengths and Difficulties(Baseline and 4 months post-intervention)
- Teacher-Student Relationships(Baseline and 4 months post-intervention)
- Disciplinary actions in classroom(Baseline and 4 months post-intervention)
- Attendance(Baseline and 4 months post-intervention)
- School Connectedness(Baseline and 4 months post-intervention)
- Teacher Stress(Baseline and 4 months post-intervention)
