RecruitingNot Applicable

Efficacy Trial of the CALM Intervention

United States218 participantsStarted 2020-12-01

Plain-language summary

Excessive anxiety among elementary students is highly prevalent and associated with impairment in academic, social, and behavioral functioning. The primary aim of this project is to evaluate the initial efficacy of a brief nurse-delivered intervention (CALM: Child Anxiety Learning Modules), relative to a credible comparison (CALM-R, relaxation skills only) and a waitlist control for reducing anxiety symptoms and improving education outcomes at post intervention and at a 1-year follow-up. In addition, the research team will assess the cost effectiveness of CALM versus CALM-R and the waitlist control and examine potential predictors, moderators, and mediators of CALM's impact on child outcomes based on the proposed theory of change.

Who can participate

Age range5 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinical Global Impression - Impairment (CGI-I) Scale, 8 weeks after baseline

Timeframe: 8 weeks after baseline

Clinical Global Impression - Impairment (CGI-I) Scale, 12-month follow-up

Timeframe: 12-month follow-up

Trial details

NCT IDNCT04693858

SponsorUConn Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-03

Contact for this trial

Golda S Ginsburg, Ph.D.

8605233788 gginsburg@uchc.edu