Recruiting

Observational Study

Sponsor:

McLaughlin Research Institute for Biomedical Sciences, Inc.

Code:

NCT07766785

Conditions

Anxiety

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Interventions

Grow with Grit

Study Details

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.

Conditions

Anxiety

Study ID

NCT07766785

Start date

Feb 9, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. GFPS students aged 8-12 years and enrolled at one of the following schools:

Mountain View Elementary West Elementary Longfellow Elementary Sunnyside Elementary School
2. 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:

1. 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.
2. Absenteeism greater than or equal to 10% of total school days due to the previously defined somatic complaints, within the past 6 weeks.
3. English-speaking without an interpreter (both student and guardian).

Exclusion Criteria

1. Currently receiving ongoing behavioral health services, including psychotherapy, psychiatric medication management, or active behavioral health case management.

1. Brief, one-time crisis counseling is not considered ongoing services.
2. Questions about eligibility should be directed to the Principal Investigator.
2. 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.
3. Documented cognitive or communication impairments that preclude meaningful completion of the SCARED screening tool or informed assent.

1. Examples include moderate to severe intellectual disability or severe receptive/expressive language disorder without feasible accommodations.
2. Students with an IEP or 504 plan that includes communication supports may be included if they can complete the tool with reasonable accommodations.
4. Students who are wards of the state or in foster care.
5. Non-English speaking students or guardians.
6. 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).

1. Such students will be triaged to crisis protocols and excluded from study participation at that time.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Grow with Grit School Nurse-Led SBIRT

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.

Interventions

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

Primary outcome measure

  • Positive Baseline Anxiety Screen Among Students Meeting the Somatic-Frequency Case-Finding Rule [ Time Frame: At baseline screening ]
  • Completion of Child and Parent Anxiety Screening [ Time Frame: At baseline screening following enrollment ]
  • Proportion of Students Meeting the Somatic-Frequency Case-Finding Rule [ Time Frame: During the six weeks preceding identification as potentially eligible ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Donna Sanders R Principal Investigator, DNP-PMH, BSN

406-799-6554donna.sanders@mclaughlinresearch.org

Rebecca Brown Clinical Research Coordinator, BSN

406-454-6045rebecca@mclaughlinresearch.org

Locations

West Elementary School

Recruiting

Great Falls, Montana, United States, 59404

Contacts

Erica Harp Lead School Nurse, RN,BSN

4062687700erica_harp@gfps.k12.mt.us

Rebecca Brown R Clinical Research Coordinator, RN

406-454-6045rebecca@mclaughlinresearch.org

Principal Investigator:

Donna Sanders, DNP, PMH

Longfellow Elementary

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Brianna St. Lawrence School Nurse, RN

4062686845erica_harp@gfps.k12.mt.us

Erica Harp R Lead School Nurse, RN, BSN

4062687700erica_harp@gfps.k12.mt.us

Principal Investigator:

Donna Sanders, DNP, PMH

Mountain View Elementary School

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Laura Chouinard School Nurse, RN

4062687305laura_chouinard@gfps.k12.mt.us

Erica Harp R Lead School Nurse, RN, BSN

4062687700erica_harp@gfps.k12.mt.us

Principal Investigator:

Donna Sanders, DNP, PMH

Sunnyside Elementary School

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Melanie Knutson School Nurse, RN, BSN

4062687115melanie_knutson@gfps.k12.mt.us

Erica Harp R Lead School Nurse, RN, BSN

4062687700erica_harp@gfps.k12.mt.us

Principal Investigator:

Donna Sanders, DNP, PMH

More Information

Sponsor

McLaughlin Research Institute for Biomedical Sciences, Inc.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by McLaughlin Research Institute for Biomedical Sciences, Inc. on 2026-08-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.