← Back to Search

CALM Intervention for Childhood Anxiety Disorder

N/A

Recruiting

Led By Golda S Ginsburg, Ph.D.

Research Sponsored by UConn Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between the ages of 5-12

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the conclusion of the calm study (4 years following the beginning of the study)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a program called CALM, where school nurses help elementary students manage anxiety using special training and materials. The goal is to see if this program can reduce anxiety and improve school performance. The study will compare CALM to a relaxation-only program to determine its effectiveness.

Who is the study for?

This trial is for elementary students aged 5-12 with anxiety, as shown by specific scores on the SCARED assessment or a clinician's rating. Kids already on stable treatment for anxiety can join if they've been steady for 4 weeks and won't change meds during the study. They must speak English well enough to understand and agree to the study.

What is being tested?

The CALM program aims to reduce kids' anxiety and improve school performance compared to just teaching relaxation (CALM-R) or doing nothing (waitlist). The team will check how cost-effective CALM is, why it works, and who benefits most over a year.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 5 and 12 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the conclusion of the calm study (4 years following the beginning of the study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the conclusion of the calm study (4 years following the beginning of the study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the conclusion of the calm study (4 years following the beginning of the study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Academic Competence Evaluation Scale (ACES), short version

Anxiety Disorders Interview Schedule for DSM-V, Parent and Child Versions (ADIS-V)

Behavioral Avoidance

+16 more

Other study objectives

CALM and CALM-R Intervention Fidelity, Adherence, Differentiation, and Competence

Child Health Utility 9-D Index (CHUD)

Child and Adolescent Services Assessment (CASA)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Child Anxiety Learning Modules (CALM)Experimental Treatment1 Intervention

Children randomly assigned to this condition will receive the CALM intervention.

Group II: Waitlist controlActive Control1 Intervention

Within each nurse, 20% (1 in 5) children will be randomly assigned to wait a period of eight weeks prior to starting the intervention with their school nurse. During this period, the child is not prevented from seeing the school nurse, nor are they prevented from continuing to utilize stable doses of community treatment (i.e., therapy outside of school or medication); nurses are simply asked to provide normal support and avoid using techniques specific to CALM or CALM-R. After the 8 weeks, youth are re-evaluated and nurses begin delivering the intervention to the student.

Group III: Child Anxiety Learning Modules--Relaxation (CALM-R)Active Control1 Intervention

Children randomly assigned to this condition will receive the CALM-R intervention.

0 / 1Eligibility criteria met