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CALM Intervention for Childhood Anxiety Disorder

N/A

Recruiting

Led By Kelly Drake, 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

Study Summary

This trial is testing whether a brief nurse-delivered intervention can help reduce anxiety symptoms and improve outcomes for elementary school students, compared to a relaxation skills intervention or a waitlist control.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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 outcome measures

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

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

Find a Location

Who is running the clinical trial?

UConn HealthLead Sponsor

211 Previous Clinical Trials

60,403 Total Patients Enrolled

Kelly Drake, Ph.D.Principal InvestigatorJohns Hopkins University

Golda S Ginsburg, Ph.D.Principal InvestigatorUConn Health

3 Previous Clinical Trials

281 Total Patients Enrolled

Media Library

Child Anxiety Learning Modules (CALM) Clinical Trial Eligibility Overview. Trial Name: NCT04693858 — N/A

Childhood Anxiety Disorder Research Study Groups: Waitlist control, Child Anxiety Learning Modules--Relaxation (CALM-R), Child Anxiety Learning Modules (CALM)

Childhood Anxiety Disorder Clinical Trial 2023: Child Anxiety Learning Modules (CALM) Highlights & Side Effects. Trial Name: NCT04693858 — N/A

Child Anxiety Learning Modules (CALM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04693858 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must individuals meet to be eligible for enrollment in this research?

"Eligible participants for this trial must have an anxiety disorder and be aged between 5 and 12 years old. A total of 218 individuals are being recruited to the study."

Answered by AI

How many participants are engaged in this research project?

"Correct. Clinicaltrials.gov indicates that this medical study, first posted on December 1st 2020, is actively enrolling new participants. 218 individuals must be recruited from 2 different sites."

Answered by AI

What are the primary aims of this investigation?

"The 12-month long medical trial's primary goal is to measure the Clinical Global Impression - Impairment (CGI-I) Scale 8 weeks after baseline. Secondary objectives include assessing Student school records - disciplinary actions using the Strength and Difficulties Questionnaire (SDQ), Teacher and Parent Versions, as well as Child Anxiety Impact Scale (CAIS)."

Answered by AI

Are any vacancies available for this medical trial?

"Affirmative. According to the clinical trial data hosted on clinicialtrials.gov, this medical research is actively recruiting participants; it was originally posted in December 1st 2020 and recently updated on May 24th 2022. The study requires 218 individuals across 2 locations to take part."

Answered by AI