NCT07766785

Brief 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. Students with a negative screen will not enter the intervention and follow-up phase.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
14mo left

Started Feb 2026

Typical duration for not_applicable anxiety

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Feb 2026Dec 2027

Study Start

First participant enrolled

February 9, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 17, 2026

Status Verified

August 1, 2026

Enrollment Period

1.5 years

First QC Date

August 5, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

pediatric anxietyschool nursingschool-based mental healthsomatic symptomsanxiety screeningearly identificationBrief cognitive behavioral interventionrural healthschool absenteeismSBIRTelementary school students

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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

    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

Other Outcomes (4)

  • Change From Baseline in Child-Reported SCARED Panic Disorder or Significant Somatic Symptoms Subscale Score

    Baseline, approximately 3 months after baseline, and approximately 6 months after baseline

  • Immediate Change in Student-Reported Body Distress Following Micro-CBT Skills Practice

    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

    During the 6 weeks preceding identification as potentially eligible

  • +1 more other outcomes

Study Arms (1)

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.

Behavioral: Grow with Grit

Interventions

Grow with GritBEHAVIORAL

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

Grow with Grit School Nurse-Led SBIRT

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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:
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

West Elementary School

Great Falls, Montana, 59404, United States

RECRUITING

Longfellow Elementary

Great Falls, Montana, 59405, United States

RECRUITING

Mountain View Elementary School

Great Falls, Montana, 59405, United States

RECRUITING

Sunnyside Elementary School

Great Falls, Montana, 59405, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 42295108BACKGROUND
  • Birmaher 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.

    PMID: 10517055BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersMedically Unexplained Symptoms

Interventions

ARHGAP32 protein, human

Condition Hierarchy (Ancestors)

Mental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Donna Sanders R Principal Investigator, DNP-PMH, BSN

CONTACT

Rebecca Brown Clinical Research Coordinator, BSN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 17, 2026

Study Start

February 9, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 17, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations