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School nurses as anxiety coaches? a new program aims to help kids cope

NCT ID NCT04693858

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether a brief program called CALM, delivered by school nurses, can reduce excessive anxiety in children aged 5 to 12. The program teaches relaxation, facing fears, and changing anxious thoughts over eight weeks. It is compared to a relaxation-only approach and a waitlist. The study also looks at whether CALM improves school outcomes and is cost-effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Child Anxiety Learning Modules (CALM), a cognitive-behavioral intervention delivered by school nurses over 8 weeks
What this could lead to
If effective, this could provide a practical, school-based way to help children with anxiety, potentially improving their academic and social functioning without needing specialized mental health care.
What could go wrong
The trial is relatively small and early-stage, and the benefits may not last beyond the follow-up period. As with any behavioral intervention, results may vary widely among children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 218 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Student Inclusion Criteria: * Be between the ages of 5-12 * Have elevated anxiety symptoms as indicated by a) a total SCARED score of 15 or higher based on parent and/or child report using the full SCARED from the baseline evaluation, and/or b) a Clinician Severity Rating of 3 or higher on any anxiety diagnosis from the Anxiety Disorders Interview Schedule for Children DSM-V (ADIS) * Be fluent in English in order to provide informed consent and assent for their participation and to complete the study measures. * Children on a stable dose of pharmacological/psychotherapeutic treatment will be eligible as long as the dose has been stable for at least 4 weeks and no changes are considered for the duration of the intervention phase of the study (8 weeks) Student Exclusion Criteria: * Children who do not meet the inclusion criteria Nurse Inclusion Criteria: * Nurses must be a Registered Nurse (RN) or another similar medical professional * Nurses must be work in the role of a school nurse * Nurses must be fluent in English

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Anxiety Treatment Center of Maryland

    Columbia, Maryland, 21045, United States

  • University of Connecticut School of Medicine

    West Hartford, Connecticut, 06119, United States

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