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Anxiety Disorder of ChildhoodNCT04693858

Efficacy Trial of the CALM Intervention

A study testing Child Anxiety Learning Modules (CALM) and Child Anxiety Learning Modules--Relaxation (CALM-R) in people with Anxiety Disorder of Childhood, run by UConn Health at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Anxiety Disorder of Childhood
What is being tested?
Child Anxiety Learning Modules (CALM) and Child Anxiety Learning Modules--Relaxation (CALM-R)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
2 sitesUnited States
Study dates
1 Dec 2020to 30 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Student Inclusion Criteria:

  • 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)

Student Exclusion Criteria:

  • Children who do not meet the inclusion criteria

Nurse 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 locations and contacts

2 sites in 1 country.

United States2 sites
  • Anxiety Treatment Center of Maryland

    Columbia, Maryland, 21045

  • University of Connecticut School of Medicine

    West Hartford, Connecticut, 06119

Other trials in United States

About this study

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

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.

Read the detailed description

Excessive anxiety among elementary age students is common, severely impairs academic, social, and behavioral functioning, and is associated with significant educational and health care costs. Despite the high burden of anxiety, less than half of children with anxiety receive the services they need to succeed in school. School clinicians can and do support these youth, however, their caseloads are high and their time to provide individualized services is limited. Consequently, there is a critical need to expand the network of providers who can assist students with anxiety and address this malleable obstacle to student academic success. Because somatic complaints, such as headaches and stomach aches, are a hallmark feature of excessive anxiety, school nurses are often the first school-based personnel to identify problematic anxiety in students. However, school nurses currently lack training in evidenced-based anxiety reduction interventions. The current study leverages findings from a three-year IES Development award (R305A140694), through which our team developed and assessed the feasibility of training elementary school nurses to use a brief intervention to reduce student anxiety; it was demonstrated that the training and intervention (i.e., Child Anxiety Learning Modules; CALM) was indeed feasible to implement and resulted in positive changes in student outcomes. CALM is now a fully developed intervention with ready-to-use intervention components and materials, training and coaching procedures, and is ready for an initial efficacy evaluation in authentic school settings. Toward that end, the primary purpose of this study is to evaluate the efficacy of CALM in a fully powered randomized controlled trial. CALM will be delivered by elementary school nurses in rural, suburban, and urban elementary schools nationwide to enhance the generalizability of findings across socioeconomic, racial, ethnic, and neighborhood settings (as approximately 80% of schools in the US have a school nurse). The efficacy of CALM will be tested using gold standard methods (e.g., independent evaluators to assess primary outcomes). The study's primary aim is to evaluate the efficacy of CALM, compared to a credible comparison condition (CALM-R; a school nurse delivered relaxation skills only intervention that parallels CALM in time and format) as well as a waitlist control, for reducing anxiety symptoms and improving educational outcomes at post-intervention and a one year follow-up. The secondary aim is to examine the cost effectiveness of CALM relative to CALM-R and the waitlist control. An exploratory aim is to examine potential predictors, moderators, and mediators of student outcomes based on the proposed theory of change. If efficacious, CALM will be the first evidenced-based school nurse delivered intervention to assist youth with excessive anxiety, filling an important gap in current practices.

Being tested
Child Anxiety Learning Modules (CALM), Child Anxiety Learning Modules--Relaxation (CALM-R)
Keywords
Anxiety, Child anxiety, School-based interventions, School nursing, Brief anxiety interventions, Cognitive-behavioral therapy
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Child Anxiety Learning Modules (CALM)Behavioural

    CALM is a cognitive-behavioral intervention for childhood anxiety. CALM consists of five modules. The primary components include psychoeducation, relaxation training (C), behavioral exposure (A), cognitive restructuring (L), and relapse prevention (M). There is also an optional parent psychoeducation module. Students randomized to the CALM condition will receive the 5 modules over 8 weeks.

  • Child Anxiety Learning Modules--Relaxation (CALM-R)Behavioural

    CALM-R serves as an active comparison condition to CALM and consists of 5 modules of relaxation skills. The key components of CALM-R include psychoeducation, deep breathing, progressive muscle relaxation, guided imagery, and relapse prevention. Students randomized to the CALM-R condition will receive the 5 modules over 8 weeks.

Study groups in NCT04693858
Study groupRoleWhat they receive
Child Anxiety Learning Modules (CALM)ExperimentalChildren randomly assigned to this condition will receive the CALM intervention.
Receives: Behavioral: Child Anxiety Learning Modules (CALM)
Child Anxiety Learning Modules--Relaxation (CALM-R)Active comparatorChildren randomly assigned to this condition will receive the CALM-R intervention.
Receives: Behavioral: Child Anxiety Learning Modules--Relaxation (CALM-R)
Waitlist controlNo interventionWithin 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The CGI-I provides a global rating of improvement in anxiety, relative to baseline. The measure yields a single rating of clinical improvement during the past week, relative to the baseline rating. Scores range from 1 (very much improved) to 7 (very much worse).

    Measured: 8 weeks after baseline

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

    The CGI-I provides a global rating of improvement in anxiety, relative to baseline. The measure yields a single rating of clinical improvement during the past week, relative to the baseline rating. Scores range from 1 (very much improved) to 7 (very much worse).

    Measured: 12-month follow-up

Secondary outcomes (19)
  1. Children's Somatization Inventory (CSI-24)

    The CSI-24 is a is 24-item child- and parent-report measure of the child's somatic symptoms. Parents and children respond to the items using a 5-point scale ranging from "not at all" to "a whole lot." One total score calculated by summing the items. Items are scored 0-4 (range: 0-96); higher scores reflect higher levels of subjective severity of somatic symptoms.

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  2. Behavioral Avoidance

    The Behavioral Avoidance form is a 3-item measure assesses how frequently the student avoids specific anxiety provoking situations. The independent evaluator creates a list of the top 3 anxiety-provoking situations and estimates the frequency with which the child avoids those situations over a two week period prior to evaluation. Avoidance for each situation is measured on a 7-point Likert scale, ranging from 1 (never avoid) to 7 (avoid every time).

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  3. Children's Automatic Thoughts Scale (CATS)

    The CATS is a 40-item measure that assesses frequency of students' maladaptive thoughts associated with anxiety. Children respond to items using a 5-point Likert-type scale describing the frequency with which they have had various thoughts over the past week (not at all, sometimes, fairly often, often, all the time). Higher scores reflect greater frequency of negative self-statements. Three scores are derived from the CATS: one total score (20 items, score range 0-80) plus two subscale scores reflecting the content of self-statements: physical threat (10 items, score range 0-40), social threat (10 items, score range 0-40).

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  4. Children's Global Assessment Scale (CGAS)

    The CGAS is a rating scale that indicates a child's global functioning on a scale of 1 (lowest) to 100 (highest). In general, scores below 70 are indicative of increasingly severe impairment in functioning.

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  5. Student Attendance Form

    The student attendance form is completed by teachers to assess the child's recent (past two weeks) school attendance including number of full and partial days missed as well as the amount of extra time and attention spent on the child.

    Measured: Two weeks prior to the evaluations

  6. School Attendance and Discipline

    The School Attendance and Discipline form is an 8-item measure completed by parents that collects information regarding absences from school related to emotional/behavioral problems as well as disciplinary actions at school.

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  7. Student school records - attendance

    Student records will be obtained from the school that will provide information regarding number of absences, tardiness, and early dismissals during the marking period closest to the dates of baseline, 8-weeks after baseline, and 12-month follow up

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  8. Student school records - disciplinary actions

    Student records will be obtained from the school that will provide information regarding number of referrals for disciplinary action during the marking period closest to the dates of baseline, 8-weeks after baseline, and 12-month follow up

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  9. Student school records - grades

    Student records will be obtained from the school that will provide information regarding English and math grades, as well as any grade retention during the marking period closest to the dates of baseline, 8-weeks after baseline, and 12-month follow up. Grades will be categorized into 4 categories: below expectations/not meeting expectations/needs more time (D); near expectations/exhibits progress towards meeting expectations/developing (C); meets expectations/consistently evident (B); exceeds expectations (A)

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  10. Student school records - special education

    Student records will be obtained from the school that will provide information regarding if the student received special education services (i.e., 504 plan and/or IEP) during the marking period closest to the dates of baseline, 8-weeks after baseline, and 12-month follow up

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  11. Subtests from the Woodcock-Johnson Tests -Achievement and Cognitive Batteries (WJ IV)

    Subtests from the WJ-IV (i.e., reading, math fluency, and digits backwards) will be administered by the IE to measure cognitive factors (e.g., efficiency, speed, working memory) that are believed to be affected by anxiety. Standard scores will be derived for the Reading Sentences Fluency, Math Facts Fluency, and Numbers Reversed subtests. Standard scores reflect the following ability level: <69=very low; 70-79=low; 80-89=low average; 90-110=average; 111-120=high average; 121-130=superior; >131=very superior.

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  12. Strength and Difficulties Questionnaire (SDQ), Teacher and Parent Versions

    The SDQ assesses a range of emotional and behavioral difficulties in children 4-17 years old (e.g., conduct problems, hyperactivity/ inattention, peer relationship problems, and prosocial behaviors). Nine scores can be derived from the SDQ. (1-5) Five subscales, each of which corresponds to 5 domains: emotional symptoms, conduct problems, hyperactivity, peer problems, prosocial problems. Subscale scores are summed. (6) The total score is generated by summing the scores from all the scales except the prosocial scale. (7-8) Externalizing scores (conduct and hyperactivity) and internalizing scores (emotional and peer problems) are also provided. (9) The impact score is a sum of questions reflecting distress and impairment. Subscale scores each range from 0-10. Externalizing and internalizing scores range from 0-20. The total score can range from 0 to 40. The impact score ranges from 0-6. Higher scores indicate higher levels of the behavior in question.

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  13. Teacher Observation of Classroom Adaptation-Checklist Concentration subscale (TOCA-C)

    The TOCA-C concentration subscale is a 7-item subscale of the TOCA that assesses teachers' perceptions of a student's classroom concentration problems. Teachers rate student concentration on a 6-point Likert scale that ranges from "never (1)" to "almost always (6)." Only the Concentration Problems subscale is used in this study. This subscale includes 7 items (range = 7-42). Higher scores on indicate more maladaptive behaviors.

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  14. Academic Competence Evaluation Scale (ACES), short version

    The ACES is a 32-item teacher report measure that assesses classroom skills and behaviors. Each item is rated on a 5 point scale (1 = never, 5= almost always), with the option to indicate that the behavior is not observed (N/O). The measure is divided in 2 main scales: Academic Skills (14, score range 0-70), consisting of Reading/Language Arts (6 items, score range 0-30), Mathematics (4 items, score range 0-20), and Critical Thinking (4 items, score range 0-20); Academic Enablers (18 items, score range 0-90), consisting of Motivation (5 items, score range 0-25), Engagement (4 items, score range 0-20), Study Skills (4 items, score range 0-20), and Interpersonal Skills (5 items, score range 0-25). Higher scores reflect higher abilities.

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  15. Child Anxiety Impact Scale (CAIS)

    The CAIS is a 27-item child- and parent-report measure of anxiety-related interference in social, academic and family functioning. Children and parents respond to items using a 4-point Likert scale (not at all, just a little, pretty much, very much); higher scores represent greater interference of anxiety in child functioning. The CAIS-C has a total score (27 items, score range 0-81) and three subscales: school (10 items, score range 0-30), social (11 items, score range 0-33), and home/family (6 items, score range 0-18).

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  16. School Anxiety Scale - Teacher Report (SAS-TR)

    The SAS is a 16-item teacher questionnaire that assesses anxiety in the school setting, with a specific focus on social and generalized anxiety symptoms relevant to classroom participation. Teachers rate student anxiety on a 4-point Likert scale that ranges from "never (0)" to "always (3)." The SAS-TR contains a total score (16 items, range of 0 to 48) and two subscales: social anxiety (7 items, range of 0-21) and generalized anxiety (9 items, range of 0 to 27). Higher scores represent higher levels of anxiety; scores of 8 and more on the social anxiety, 10 or more on the generalized anxiety, and 17 or more on the total anxiety is considered to represent high anxious condition.

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  17. Clinical Global Impression - Severity (CGI-S) Scale

    The CGI-S provides a global rating of anxiety severity. The measure yields a single rating of anxiety symptom severity during the past week. Scores range from 1 (Normal; Not at all ill) to 7 (Extremely ill)

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

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

    The ADIS-V is a structured interview that assesses anxiety diagnoses and severity in youth. Impairment ratings are generated for each diagnosis using the Clinician Severity Rating (CSR, range = 0-8; higher CSRs indicate higher severity of anxiety disorders, a CSR of 4 is required to assign a diagnosis). Diagnoses are derived separately from the child and parent report, which yields a Composite Diagnosis that is one measure used to determine study eligibility.

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

  19. Screen for Child Anxiety-Related Emotional Disorders (SCARED), parent and child versions

    The SCARED is a 41-item child- and parent-report measure of anxiety. Youth and parents respond to items using a 3-point Likert-type scale describing the degree to which statements are true (0 = not true or hardly ever true, 1 = somewhat true or sometimes true, 2 = very true or often true). Higher scores represent higher levels of anxiety. Six scores can be derived from the SCARED: one total score (41 items, score range 0-82) plus five subscale scores: panic/somatic (13 items, score range 0-26), generalized anxiety (9 items, score range 0-18), (3) separation anxiety (8 items, score range 0-16), social anxiety (7 items, score range 0-14), and school phobia (4 items, score range 0-8).

    Measured: Baseline, 8 weeks after baseline, 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2021
  2. Study start1 Dec 2020
  3. Primary completion3 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study involves a cluster-randomized controlled trial to compare CALM to CALM-R and a weighted waitlist control (WLC) group (4 CALM/CALM-R:1 WLC).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
218 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04693858
Sponsor's protocol ID
21-037-2
Other IDs
R305A200195
Status last verified
Aug 2026
First submitted
14 Dec 2020
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 1. Publications: we will submit all publications to the ERIC within 12 months of the publisher's official date of final publication. We will also email copies of publications to interested parties upon request. 2. Data Access/Sharing: We will provide timely access to the final research data (including data file in SPSS format and a variable codebook). We will share only cleaned, de-identified or synthetic data. These data include surveys/interviews and school records. We will create a data documentation file (i.e., description of all original and derived/summary variables and definitions) to accompany the data file. The documentation will include a description of the study, data collection forms, study protocol/procedures, descriptions of variable recoding performed, and a list of major study publications and investigators.

Publications

  • Ginsburg GS, Drake KL, Muggeo MA, Stewart CE, Pikulski PJ, Zheng D, Harel O. A pilot RCT of a school nurse delivered intervention to reduce student anxiety. J Clin Child Adolesc Psychol. 2021 Mar-Apr;50(2):177-186. doi: 10.1080/15374416.2019.1630833. Epub 2019 Aug 2.

    PubMed 31373524
  • Drake KL, Stewart CE, Muggeo MA, Ginsburg GS. Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: Development of the CALM Intervention. J Child Adolesc Psychiatr Nurs. 2015 Aug;28(3):121-30. doi: 10.1111/jcap.12115. Epub 2015 Jul 14.

    PubMed 26171792
  • Muggeo, M. A., Stewart, C. E., Drake, K. L., & Ginsburg, G. S. (2017). A school nurse-delivered intervention for anxious children: An open trial. School Mental Health, 9(2) 157-171.

Questions about this trial

What is this clinical trial studying?

A study testing Child Anxiety Learning Modules (CALM) and Child Anxiety Learning Modules--Relaxation (CALM-R) in people with Anxiety Disorder of Childhood, run by UConn Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Global Impression - Impairment (CGI-I) Scale, 8 weeks after baseline (time frame: 8 weeks after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04693858, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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