RECRUITING

Efficacy Trial of the CALM Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: An Efficacy Trial of the CALM Intervention

Quick Facts

Study Start:2020-12-01
Study Completion:2025-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04693858

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Be between the ages of 5-12
  2. * 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)
  3. * Be fluent in English in order to provide informed consent and assent for their participation and to complete the study measures.
  4. * 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)
  1. * Children who do not meet the inclusion criteria

Contacts and Locations

Study Contact

Golda S Ginsburg, Ph.D.
CONTACT
8605233788
gginsburg@uchc.edu
Kelly Drake, Ph.D.
CONTACT
4108007591
kdrake2@jhmi.edu

Principal Investigator

Golda S Ginsburg, Ph.D.
PRINCIPAL_INVESTIGATOR
UConn Health
Kelly Drake, Ph.D.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

University of Connecticut School of Medicine
West Hartford, Connecticut, 06119
United States
Anxiety Treatment Center of Maryland
Columbia, Maryland, 21045
United States

Collaborators and Investigators

Sponsor: UConn Health

  • Golda S Ginsburg, Ph.D., PRINCIPAL_INVESTIGATOR, UConn Health
  • Kelly Drake, Ph.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-01
Study Completion Date2025-07-30

Study Record Updates

Study Start Date2020-12-01
Study Completion Date2025-07-30

Terms related to this study

Keywords Provided by Researchers

  • Anxiety
  • Child anxiety
  • School-based interventions
  • School nursing
  • Brief anxiety interventions
  • Cognitive-behavioral therapy

Additional Relevant MeSH Terms

  • Anxiety Disorder of Childhood