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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 belowSelect...
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)
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 moreOther 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 moreTrial 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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child's medication or therapy dose has been stable for 4 weeks and won't change for the next 8 weeks.I am between 5 and 12 years old.You need to be able to speak and understand English well enough to fully understand the study and give consent to participate.You have been diagnosed with anxiety by a doctor or have a score of 15 or higher on a test to measure anxiety symptoms.This criterion is incomplete and requires further information about the context.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist control
- Group 2: Child Anxiety Learning Modules--Relaxation (CALM-R)
- Group 3: Child Anxiety Learning Modules (CALM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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