Efficacy Trial of the CALM Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorUConn Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Children who do not meet the 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 design

Design model

Parallel

Treatments tested in this trial

  • Child Anxiety Learning Modules (CALM)

    Behavioral

    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)

    Behavioral

    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.

Treatment groups

218 Participants
are divided into 3 treatment groups
Group A: Child Anxiety Learning Modules (CALM)Experimental treatment 1 intervention
Group B: Child Anxiety Learning Modules--Relaxation (CALM-R)Active comparator 1 intervention
Group C: Waitlist controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

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).

Time frame
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).

Time frame
12-month follow-up

Secondary outcomes

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.

Time frame
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).

Time frame
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).

Time frame
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.

Time frame
Baseline, 8 weeks after baseline, 12-month follow-up

Other outcomes

1

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

The CALM and CALM-R Intervention Fidelity, Adherence, Differentiation, and Competence forms contain key points/principles that should be covered during each CALM and CALM-R module and assesses whether they were covered (yes/no), the quality of administration (using a 4 point scale where 1 = poor to 4 = very good), and non-specific factors (e. g., maintains a positive working relationship). For adherence, a yes indicates nurses adhere to the manual; no indicates nurses did not adhere for that particular item. For quality, highest scores indicate greater quality of competence in delivering the intervention components.

Time frame
After each session of the CALM or CALM-R intervention is delivered (approximately 1 session of the intervention delivered each week, for up to 8 weeks)
2

Independent Evaluator (IE) masking form

The IE masking form is a 1-item measure that asks the IE to guess the student's intervention assignment in order to assess the integrity of the masking procedures.

Time frame
After post (8-week) and follow up (12-month) evaluations
3

Session Summary Form (SSF)

The SSF captures pertinent information about the session such as duration, attendance, intervention strategy, and ratings of the quality of the therapeutic relationship, child compliance, and nurse's perceived competence.

Time frame
After each session of the CALM or CALM-R intervention is delivered (approximately 1 session of the intervention delivered each week, for up to 8 weeks)
4

Nurse Background Form

The nurse background form assesses demographic characteristics and professional experience (e.g., training, years of experience, license).

Time frame
Baseline

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