AnxietyGwGNCT07766785
Grow With Grit: A School Nurse-Led SBIRT Pilot for Early Anxiety Detection
A study testing Grow with Grit in people with Anxiety, run by McLaughlin Research Institute for Biomedical Sciences, Inc. at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Grow with Grit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Feb 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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).
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Donna Sanders R Principal Investigator, DNP-PMH, BSN contact
United States4 sites, 4 recruiting
- Recruiting
West Elementary School
Great Falls, Montana, 59404
Erica Harp Lead School Nurse, RN,BSN, 4062687700, erica_harp@gfps.k12.mt.us
Rebecca Brown R Clinical Research Coordinator, RN, 406-454-6045, rebecca@mclaughlinresearch.org
- Recruiting
Longfellow Elementary
Great Falls, Montana, 59405
Brianna St. Lawrence School Nurse, RN, 4062686845, erica_harp@gfps.k12.mt.us
Erica Harp R Lead School Nurse, RN, BSN, 4062687700, erica_harp@gfps.k12.mt.us
- Recruiting
Mountain View Elementary School
Great Falls, Montana, 59405
Laura Chouinard School Nurse, RN, 4062687305, laura_chouinard@gfps.k12.mt.us
Erica Harp R Lead School Nurse, RN, BSN, 4062687700, erica_harp@gfps.k12.mt.us
- Recruiting
Sunnyside Elementary School
Great Falls, Montana, 59405
Melanie Knutson School Nurse, RN, BSN, 4062687115, melanie_knutson@gfps.k12.mt.us
Erica Harp R Lead School Nurse, RN, BSN, 4062687700, erica_harp@gfps.k12.mt.us
About this study
Official title: Grow With Grit: A Nurse-Led SBIRT Model for Early Anxiety Detection and School-Based Mental Health Intervention in Rural Youth
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.
Read the detailed description
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.
- Conditions
- Anxiety
- Being tested
- Grow with Grit
- Keywords
- pediatric anxiety, school nursing, school-based mental health, somatic symptoms, anxiety screening, early identification, Brief cognitive behavioral intervention, rural health, school absenteeism, SBIRT, elementary school students
- Medical subject headings
- Anxiety Disorders, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grow with GritBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Grow with Grit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From determination of a positive baseline anxiety screen until completion of the standardized micro-CBT intervention, assessed up to 6 months after baseline
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The six-week periods preceding baseline, approximately 3 months after baseline, and approximately 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start9 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group study in which students who screen positive for anxiety receive the same school nurse-led brief intervention and referral workflow. There is no comparison group.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McLaughlin Research Institute for Biomedical Sciences, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766785
- Sponsor's protocol ID
- MRI0005
- Acronym
- GwG
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruth D, Hammersla M, Tanner A. Implementation of a School Nurse-Led Case-Finding and Targeted Anxiety Testing Protocol (SBIRT-Informed) in an Elementary School: A Quality Improvement Initiative. J Sch Nurs. 2026 Jun 15:10598405261455898. doi: 10.1177/10598405261455898. Online ahead of print.
PubMed 42295108Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011.
PubMed 10517055
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grow With Grit: A Nurse-Led SBIRT Model for Early Anxiety Detection and School-Based Mental Health Intervention in Rural Youth
- ClinicalTrials.gov ID
- NCT07766785
- Acronym / sponsor ID
- GwG / MRI0005
- Conditions
- Anxiety
- Keywords
- pediatric anxiety, school nursing, school-based mental health, somatic symptoms, anxiety screening, early identification, Brief cognitive behavioral intervention, rural health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McLaughlin Research Institute for Biomedical Sciences, Inc.University, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group study in which students who screen positive for anxiety receive the same school nurse-led brief intervention and referral workflow. There is no comparison group.
| Arm | Type | Receives |
|---|---|---|
| Grow with Grit School Nurse-Led SBIRT | Experimental | Behavioral: Grow with GritParticipants 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (12 listed)
- 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).
- Documented cognitive or communication impairments that preclude meaningful completion of the SCARED screening tool or informed assent.
- Students who are wards of the state or in foster care.
- Non-English speaking students or guardians.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grow with GritAfter 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 | Behavioural | Grow with Grit School Nurse-Led SBIRT |
Primary outcome
Positive Baseline Anxiety Screen Among Students Meeting the Somatic-Frequency Case-Finding Rule
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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.
4 secondary outcomes
Change From Baseline in Child-Reported SCARED Total Score
Time frame: Baseline, approximately 3 months after baseline, and approximately 6 months after baseline
Change From Baseline in SCARED-Parent Version Total Score
Time frame: Baseline, approximately 3 months after baseline, and approximately 6 months after baseline
Somatic-Related School Nurse Visits During Follow-Up
Time frame: From baseline through 6 months after baseline
Change From Baseline in Percentage of Enrolled School Days Absent
Time frame: The six-week periods preceding baseline, approximately 3 months after baseline, and approximately 6 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 42295108Ruth D, Hammersla M, Tanner A. Implementation of a School Nurse-Led Case-Finding and Targeted Anxiety Testing Protocol (SBIRT-Informed) in an Elementary School: A Quality Improvement Initiative. J Sch Nurs. 2026 Jun 15:10598405261455898. doi: 10.1177/10598405261455898. Online ahead of print.
- Background: PubMed 10517055Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Donna Sanders R Principal Investigator, DNP-PMH, BSN contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grow with Grit in people with Anxiety, run by McLaughlin Research Institute for Biomedical Sciences, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna Sanders R Principal Investigator, DNP-PMH, BSN (406-799-6554, donna.sanders@mclaughlinresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Baseline Anxiety Screen Among Students Meeting the Somatic-Frequency Case-Finding Rule (time frame: At baseline screening). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07766785, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.