跳至主要内容
临床试验/NCT07766785
NCT07766785招募中不适用

Grow With Grit: A Nurse-Led SBIRT Model for Early Anxiety Detection and School-Based Mental Health Intervention in Rural Youth

McLaughlin Research Institute for Biomedical Sciences, Inc.4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
4
主要终点
Positive Baseline Anxiety Screen Among Students Meeting the Somatic-Frequency Case-Finding Rule

研究概览

简要总结

All enrolled students and their parents or guardians will complete baseline anxiety questionnaires. Students with a positive baseline screen will receive a brief school nurse-delivered coping skill, referral support when indicated, and follow-up assessments at approximately three and six months. Students with a negative screen will not enter the intervention and follow-up phase.

详细描述

Anxiety in elementary-aged children may first appear as headaches, stomachaches, fatigue, nausea, dizziness, or other physical symptoms. These concerns can lead to repeated school health-office visits, difficulty remaining in class, and missed school before a child recognizes or reports feeling anxious. Such patterns are particularly important in rural schools, where access to onsite behavioral health professionals may be limited.

Grow with Grit is a prospective, single-cohort Hybrid Type II pilot clinical trial conducted in four public elementary schools in Great Falls, Montana. The study includes students ages 8 to 12 who are enrolled in grades 3 through 5. It evaluates a school nurse-led Screening, Brief Intervention, and Referral to Treatment (SBIRT) workflow while examining how well the workflow functions in routine school practice. The pilot focuses on feasibility, acceptability, fidelity, and preliminary changes in student outcomes. Because the study has no comparison group, its findings will be used to inform a future controlled trial.

The workflow uses targeted case-finding rather than screening every student. School nurses review routine health-office and attendance records to identify students who have repeated physical complaints or an attendance pattern associated with those complaints, as defined in the study eligibility criteria. Physical symptoms must not be fully explained by an acute illness, injury, or known medical condition. Meeting a case-finding threshold indicates that anxiety screening may be appropriate; it does not mean that the student has an anxiety disorder. Attendance is also examined as a measure of school engagement and as a possible identification signal for future studies in schools with limited nursing coverage.

After parent or guardian permission and child assent are obtained, the student and parent or guardian complete the child and parent versions of the Screen for Child Anxiety Related Emotional Disorders (SCARED). This validated, 41-item questionnaire assesses symptoms related to generalized anxiety, separation anxiety, social anxiety, panic or physical symptoms, and school avoidance. A score of 25 or higher on either version is considered a positive screen and suggests that further evaluation or support may be appropriate.

Students with a negative screen do not enter the intervention and six-month follow-up phase. The nurse informs the student and parent or guardian of the result. The student may continue to receive routine school health services and use universal school wellness resources. Re-screening may be considered through usual school processes if symptoms persist or new concerns develop.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • GFPS students aged 8-12 years and enrolled at one of the following schools:
  • Mountain View Elementary West Elementary Longfellow Elementary Sunnyside Elementary School
  • Participants will be identified through a weekly review of school nurse electronic health records (Frontline EHR) and attendance logs, and will include students who have either:
  • Three or more nurse visits for somatic complaints within the past 6 weeks. For this study, somatic complaints are defined as the following physical symptoms that are not otherwise linked to exclusionary illness or chronic medical processes: stomach aches, headaches, fatigue, & generalized muscle aches.
  • Absenteeism greater than or equal to 10% of total school days due to the previously defined somatic complaints, within the past 6 weeks.
  • English-speaking without an interpreter (both student and guardian).

排除标准

  • Currently receiving ongoing behavioral health services, including psychotherapy, psychiatric medication management, or active behavioral health case management.
  • Brief, one-time crisis counseling is not considered ongoing services.
  • Questions about eligibility should be directed to the Principal Investigator.
  • Presence of a chronic medical diagnosis that fully accounts for the student's repeated somatic visits (e.g., asthma with frequent exacerbations, epilepsy, diabetes, sickle cell disease, or active cancer treatment).
  • a. Students with partially explained symptoms who are also suspected to have co-occurring anxiety may be reviewed on a case-by-case basis by the PI/designee.
  • Documented cognitive or communication impairments that preclude meaningful completion of the SCARED screening tool or informed assent.
  • Examples include moderate to severe intellectual disability or severe receptive/expressive language disorder without feasible accommodations.
  • Students with an IEP or 504 plan that includes communication supports may be included if they can complete the tool with reasonable accommodations.
  • Students who are wards of the state or in foster care.
  • Non-English speaking students or guardians.
  • Acute safety concerns at the time of screening (e.g., active suicidal ideation with plan/intent, recent suicide attempt, or other crisis requiring immediate intervention).
  • Such students will be triaged to crisis protocols and excluded from study participation at that time.

研究组 & 干预措施

Grow with Grit School Nurse-Led SBIRT

Experimental

Participants complete child and parent anxiety screening. Students who screen positive receive a brief school nurse-led coping-skills intervention, referral through the school's existing mental health support pathway, and follow-up assessments at approximately three and six months. Students who screen negative do not continue into the intervention and follow-up phase.

干预措施: Grow with Grit (Behavioral)

结局指标

主要结局

Positive Baseline Anxiety Screen Among Students Meeting the Somatic-Frequency Case-Finding Rule

时间窗: At baseline screening

Percentage of enrolled students who met the somatic-frequency case-finding rule, completed both baseline anxiety questionnaires, and had a positive baseline anxiety screen. The somatic-frequency rule is defined as three or more school-nurse visits involving qualifying somatic complaints within the previous six weeks. A positive screen is defined as a total score of 25 or higher on either the 41-item SCARED-Child Version or the 41-item SCARED-Parent Version. The percentage is calculated as the number of students meeting the rule who had a positive baseline screen divided by the number of students meeting the rule who completed both baseline questionnaires, multiplied by 100.

Completion of Child and Parent Anxiety Screening

时间窗: At baseline screening following enrollment

Percentage of students with parent or guardian consent and child assent for whom both the 41-item SCARED-Child Version and the 41-item SCARED-Parent Version are completed at baseline. The percentage is calculated as the number of students who complete both baseline questionnaires divided by the total number of students with parent or guardian consent and child assent, multiplied by 100.

Proportion of Students Meeting the Somatic-Frequency Case-Finding Rule

时间窗: During the six weeks preceding identification as potentially eligible

Percentage of enrolled students who met the somatic-frequency case-finding rule when identified as potentially eligible. The rule is defined as three or more school-nurse visits involving qualifying somatic complaints within the previous six weeks. The percentage is calculated as the number of enrolled students who met the somatic-frequency rule divided by the total number of enrolled students, multiplied by 100. Students may meet the somatic-frequency rule, the absenteeism trigger, or both.

Fidelity to the School Nurse-Delivered Micro-CBT Intervention

时间窗: At each documented micro-CBT interaction from baseline through the 6-month follow-up

Percentage of documented school nurse-delivered micro-CBT encounters in which all required intervention components are documented as completed: brief explanation of the connection between body signals and stress or worry, guided practice of one card-based coping skill, and development or reinforcement of a brief plan for using the skill. The percentage is calculated as the number of encounters in which all required components are documented as completed divided by the total number of documented micro-CBT encounters, multiplied by 100. Missing documentation of a required component will be treated as that component not being documented as completed. Optional body-distress ratings, reflection, and the student's disposition following the encounter are not required for intervention fidelity.

Completion of Behavioral Health Referrals Among Students with a Positive Baseline Anxiety Screen

时间窗: From the positive baseline anxiety screen through the 6-month follow-up

Percentage of students with a positive baseline anxiety screen for whom a school-based or community-based behavioral health referral is documented as completed. A positive screen is defined as a total score of 25 or higher on either the 41-item SCARED-Child Version or the 41-item SCARED-Parent Version. The percentage is calculated as the number of students with a positive baseline screen whose referral is documented as completed divided by the total number of students with a positive baseline screen, multiplied by 100. School nurses initiate an MTSS-aligned referral for students with a positive screen. Referral initiation, status, engagement, completion, and barriers are documented through the school's MTSS-aligned tracking process and study case-report form.

Completion of the School Nurse-Delivered Micro-CBT Intervention

时间窗: From determination of a positive baseline anxiety screen until completion of the standardized micro-CBT intervention, assessed up to 6 months after baseline

Percentage of students with a positive baseline anxiety screen who receive the standardized 3- to 5-minute school nurse-delivered micro-CBT interaction. A positive screen is defined as a total score of 25 or higher on either the 41-item SCARED-Child Version or the 41-item SCARED-Parent Version. The percentage is calculated as the number of students with a positive baseline screen who receive the micro-CBT interaction divided by the total number of students with a positive baseline screen, multiplied by 100. Completion is documented in the Individual Student Tracker and micro-CBT encounter record.

次要结局

  • Change From Baseline in Child-Reported SCARED Total Score(Baseline, approximately 3 months after baseline, and approximately 6 months after baseline)
  • Change From Baseline in SCARED-Parent Version Total Score(Baseline, approximately 3 months after baseline, and approximately 6 months after baseline)
  • Somatic-Related School Nurse Visits During Follow-Up(From baseline through 6 months after baseline)
  • Change From Baseline in Percentage of Enrolled School Days Absent(The six-week periods preceding baseline, approximately 3 months after baseline, and approximately 6 months after baseline)

研究者

发起方
McLaughlin Research Institute for Biomedical Sciences, Inc.
申办方类型
Other
责任方
Sponsor

研究点 (4)

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