An interventional study of Grow with Grit in Anxiety, sponsored by McLaughlin Research Institute for Biomedical Sciences, Inc.. Recruiting at 4 sites in United States. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by McLaughlin Research Institute for Biomedical Sciences, Inc. · Not applicable, Interventional, and Screening
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.
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.
Students with a positive screen receive a standardized, three- to five-minute intervention from the school nurse during the same or next clinically appropriate encounter. The intervention uses cognitive behavioral therapy principles to help the student understand connections among body signals, thoughts, feelings, and stress. The nurse introduces and practices a skill matched to the student's concern, such as paced breathing, grounding, gentle movement, or reframing an unhelpful thought. The nurse and student then make a brief plan for using the skill and returning to class when appropriate. Skills may be reinforced during later school nurse encounters.
Following a positive screen, the nurse initiates a referral through the school's existing Multi-Tiered System of Supports (MTSS) mental health pathway. Support may involve a school counselor, psychologist, social worker, school-based program, primary care professional, or community behavioral health provider. The school team and family determine which services best fit the student's needs and available local resources. Referral progress, engagement, and barriers to obtaining services are documented as part of the study workflow.
Students who screen positive are followed for approximately six months. The child version of the SCARED is completed at baseline and again at approximately three and six months. The parent version is completed by the parent or guardian at baseline and by the parent, guardian, or primary care provider at follow-up, as permitted by the protocol. During routine school nurse encounters, nurses document relevant physical complaints, coping-skill use, skill reinforcement, and referral progress. Health-office and attendance records are also reviewed to examine changes during participation. The study does not require separate research visits outside regular school activities.
At the six-month follow-up, parents or guardians and, when appropriate, students may participate in an optional 10- to 15-minute exit interview. The interview asks about the acceptability, usefulness, and feasibility of the study procedures. Interviews are not audio-recorded, and participation is not required to remain in the study or receive services.
The implementation evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. It examines whether the workflow reaches eligible students, can be completed consistently, fits within school nursing and MTSS practices, and may be maintained over time. School nurse feedback is used to identify workflow burden, training needs, implementation barriers, and needed refinements. Findings will guide future case-finding procedures, nurse training, referral processes, data collection, and the design of a larger trial.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →McLaughlin Research Institute for Biomedical Sciences, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria
Currently receiving ongoing behavioral health services, including psychotherapy, psychiatric medication management, or active behavioral health case management.
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.
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).
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.
Behavioral: Grow with Grit
After targeted case-finding and enrollment, students and their parents or guardians complete the child and parent versions of the Screen for Child Anxiety Related Emotional Disorders (SCARED). Students with a score of 25 or higher on either version receive a standardized three- to five-minute, school nurse-delivered micro-CBT intervention during the same or next clinically appropriate encounter. The nurse provides brief psychoeducation about connections among body signals, thoughts, feelings, and stress; practices a coping skill matched to the student's concern, such as paced breathing, grounding, gentle movement, or cognitive reframing; and develops a brief plan for using the skill and returning to class when appropriate. The nurse also initiates a referral through the school's existing MTSS-aligned mental health pathway. Coping skills may be reinforced during subsequent school nurse encounters. Students who screen negative do not receive the study micro-CBT intervention or enter the
Positive Baseline Anxiety Screen Among Students Meeting the Somatic-Frequency Case-Finding Rule
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.
Time frame: At baseline screening
Completion of Child and Parent Anxiety Screening
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.
Time frame: At baseline screening following enrollment
Proportion of Students Meeting the Somatic-Frequency Case-Finding Rule
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.
Time frame: During the six weeks preceding identification as potentially eligible
Fidelity to the School Nurse-Delivered Micro-CBT Intervention
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.
Time frame: At each documented micro-CBT interaction from baseline through the 6-month follow-up
Completion of Behavioral Health Referrals Among Students with a Positive Baseline Anxiety Screen
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.
Time frame: From the positive baseline anxiety screen through the 6-month follow-up
Completion of the School Nurse-Delivered Micro-CBT Intervention
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.
Time frame: From determination of a positive baseline anxiety screen until completion of the standardized micro-CBT intervention, assessed up to 6 months after baseline
Change From Baseline in Child-Reported SCARED Total Score
Change in child-reported anxiety symptoms measured using the 41-item Screen for Child Anxiety Related Emotional Disorders-Child Version (SCARED-C). Each item is scored from 0 to 2, producing a total score ranging from 0 to 82; higher scores indicate greater anxiety symptoms. Change is calculated as the follow-up total score minus the baseline total score, with negative values indicating decreased anxiety symptoms. Change will be calculated separately from baseline to approximately Month 3 and from baseline to approximately Month 6.
Time frame: Baseline, approximately 3 months after baseline, and approximately 6 months after baseline
Change From Baseline in SCARED-Parent Version Total Score
Change in anxiety symptoms measured using the 41-item Screen for Child Anxiety Related Emotional Disorders-Parent Version (SCARED-P), completed by the parent or guardian or obtained from the student's primary care provider as permitted by the approved protocol. Each item is scored from 0 to 2, producing a total score ranging from 0 to 82; higher scores indicate greater anxiety symptoms. Change is calculated as the follow-up total score minus the baseline total score, with negative values indicating decreased anxiety symptoms. Change will be calculated separately from baseline to approximately Month 3 and from baseline to approximately Month 6.
Time frame: Baseline, approximately 3 months after baseline, and approximately 6 months after baseline
Somatic-Related School Nurse Visits During Follow-Up
Number of school nurse encounters related to somatic complaints documented for each participant during the six-month follow-up period. Encounters will be identified using routine school health-office records and study case-report forms. The number of documented encounters will be summarized descriptively.
Time frame: From baseline through 6 months after baseline
Change From Baseline in Percentage of Enrolled School Days Absent
Change in the percentage of enrolled instructional days each participant was absent during the six-week periods preceding baseline, approximately Month 3, and approximately Month 6. At each assessment, the percentage is calculated as the number of enrolled instructional days absent divided by the total number of enrolled instructional days in the applicable six-week observation period, multiplied by 100. Change is calculated separately from baseline to approximately Month 3 and from baseline to approximately Month 6, with negative values indicating decreased absenteeism. Attendance information will be obtained from existing school records.
Time frame: The six-week periods preceding baseline, approximately 3 months after baseline, and approximately 6 months after baseline
Change From Baseline in Child-Reported SCARED Panic Disorder or Significant Somatic Symptoms Subscale Score
Change in child-reported panic and somatic anxiety symptoms measured using the 13-item panic disorder or Significant Somatic Symptoms subscale of the SCARED-Child Version. Each item is scored from 0 to 2, producing a subscale score ranging from 0 to 26; higher scores indicate greater symptoms. Change is calculated as the follow-up subscale score minus the baseline subscale score, with negative values indicating decreased symptoms. Change will be calculated separately from baseline to approximately Month 3 and from baseline to approximately Month 6
Time frame: Baseline, approximately 3 months after baseline, and approximately 6 months after baseline
Immediate Change in Student-Reported Body Distress Following Micro-CBT Skills Practice
Change in student-reported body distress measured immediately before and after micro-CBT skills practice using a study-developed rating ranging from 0 to 10, where 0 indicates that the student's body feels calm or has no distress and 10 indicates the greatest body distress the student can imagine. The scale is presented using numbers and corresponding visual indicators. The student may state a number, select a number, or point to the matching visual indicator; one score from 0 to 10 is recorded. Change is calculated as the post-practice rating minus the pre-practice rating, with negative values indicating decreased distress. Optional free-text notes may be recorded but will not be included in the numerical change score. Encounters without both ratings will be reported as missing from the paired analysis.
Time frame: Immediately before and after each micro-CBT skills-practice encounter, from baseline through the 6-month follow-up
Proportion of Enrolled Students Meeting the Absenteeism Case-Finding Trigger
Percentage of enrolled students who met the absenteeism case-finding trigger when identified as potentially eligible. The trigger is defined as absence from at least 10% of enrolled school days during the previous six weeks due to qualifying somatic complaints. The percentage is calculated as the number of enrolled students who met the absenteeism trigger divided by the total number of enrolled students, multiplied by 100. Students may meet the absenteeism trigger, the somatic-frequency trigger, or both.
Time frame: During the 6 weeks preceding identification as potentially eligible
School Nurse-Reported Feasibility and Acceptability of the SBIRT Workflow
Descriptive school nurse feedback regarding implementation of the SBIRT workflow, including workflow fit, burden or logistical challenges, confidence delivering screening and micro-CBT procedures, and integration with existing MTSS processes. Feedback collected through the Nurse Weekly Tally Sheet will be summarized descriptively. No composite score will be calculated.
Time frame: Weekly during study recruitment and implementation, up to one academic year
Plan to share: No
Started Feb 2026 (actual). Primary completion is estimated for Aug 2027, 18 months after the start.
Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 18 months is above that.
Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
McLaughlin Research Institute for Biomedical Sciences, Inc.