Efficacy Trial of the CALM Intervention

Conditions

• Anxiety Disorder of Childhood

Eligibility Criteria

Sex

ALL

Age

5 Years - 12 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Dec 1, 2020

Status verified

Dec 2024

Primary completion

Jul 3, 2026

Completion

Jul 30, 2026

Study Design

Enrollment

218 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Child Anxiety Learning Modules (CALM)
  Children randomly assigned to this condition will receive the CALM intervention.
• Active Comparator: Child Anxiety Learning Modules--Relaxation (CALM-R)
  Children randomly assigned to this condition will receive the CALM-R intervention.
• No Intervention: Waitlist control
  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.

Primary Outcome Measure

Clinical Global Impression - Impairment (CGI-I) Scale, 8 weeks after baseline [ Time Frame: 8 weeks after baseline ]

Central Contacts

• Golda S Ginsburg, Ph.D.
  8605233788
  [email protected]
• Kelly Drake, Ph.D.
  4108007591
  [email protected]

Locations (2)

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