Efficacy Trial of the CALM Intervention
ConditionAnxiety Disorder of Childhood
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorUConn Health
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Children who do not meet the 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
Trial design
Treatments tested in this trial
- Child Anxiety Learning Modules (CALM)
- Child Anxiety Learning Modules--Relaxation (CALM-R)
Treatment groups
218 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov