CALM Intervention for Childhood Anxiety Disorder

Recruiting at 1 trial location

Overseen By Kelly Drake, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: UConn Health

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

218 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to test a program called CALM, where school nurses help elementary students manage anxiety using special training and materials. The goal is to see if this program can reduce anxiety and improve school performance. The study will compare CALM to a relaxation-only program to determine its effectiveness.

Will I have to stop taking my current medications?

You can continue taking your current medications as long as the dose has been stable for at least 4 weeks and no changes are planned during the 8-week intervention phase.

What data supports the effectiveness of the CALM treatment for childhood anxiety disorder?

The CALM treatment is designed to help reduce anxiety in children, and similar approaches like Cognitive Behavioral Therapy (CBT) have strong support for treating childhood anxiety. Additionally, school-based relaxation training programs have been shown to help children with anxiety-related issues, suggesting that components of CALM may be effective. ^{1 2 3 4 5}

Is the CALM intervention for childhood anxiety disorders safe?

The CALM intervention for childhood anxiety disorders has been evaluated in studies, and while specific safety data for CALM itself is not detailed, related treatments like clonazepam have shown few serious side effects in children when used carefully. Safety signal learning, a related approach, has been effective in reducing anxiety-like behavior in animal models and healthy adults, suggesting it may be safe for use in youths. ^{6 7 8 9 10}

How is the CALM treatment for childhood anxiety different from other treatments?

The CALM treatment is unique because it is designed to be delivered by school nurses, making it accessible in a school setting where children often seek help for anxiety-related issues. This approach allows for early intervention and aims to improve both anxiety symptoms and academic performance. ^{1 2 11 12 13}

Research Team

Golda S Ginsburg, Ph.D.

Principal Investigator

UConn Health

Kelly Drake, Ph.D.

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants assigned to the waitlist control will wait for 8 weeks before starting the intervention

8 weeks

Regular visits with school nurse as needed

Treatment

Participants receive the CALM or CALM-R intervention delivered by school nurses

8 weeks

Weekly sessions with school nurse

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Periodic evaluations at 8 weeks and 12 months

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: Child Anxiety Learning Modules (CALM) Experimental Treatment 1 Intervention

Children randomly assigned to this condition will receive the CALM intervention.

Group II: Waitlist control Active Control 1 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 Control 1 Intervention

Children randomly assigned to this condition will receive the CALM-R intervention.

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

Findings from Research

The study aims to develop and test the Child Anxiety Learning Modules (CALM), an intervention delivered by school nurses, to help reduce anxiety in children and improve their academic performance.

Data will be collected on various outcomes, including anxiety symptoms and school performance, to evaluate the effectiveness and feasibility of CALM, highlighting the important role school nurses can play in addressing pediatric anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: Development of the CALM Intervention. Drake, KL., Stewart, CE., Muggeo, MA., et al.[2023]

School-based relaxation training programs, particularly progressive muscle relaxation, have been adapted for children to help with anxiety issues like headaches and test anxiety, but the improvements observed are generally modest.

The review suggests that while relaxation training can be beneficial, the goals for treatment should be realistic, and more comprehensive approaches may be needed to effectively reduce anxiety and improve performance in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of relaxation training with children in school settings: a plea for realistic goal setting and evaluation. King, NJ., Ollendick, TH., Murphy, GC., et al.[2019]

A study involving 90 children aged 6-17 showed that both a child-friendly educational video and standard information significantly reduced pre-operative anxiety levels, but there was no significant difference in anxiety reduction between the two groups.

Children and parents who viewed the educational video reported fewer worries compared to those who only received standard information, suggesting that the video may enhance patient satisfaction and comfort before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Educational Video on Pre-operative Anxiety in Children - A Randomized Controlled Trial. Härter, V., Barkmann, C., Wiessner, C., et al.[2021]

The Children's Anxiety Meter-State (CAM-S) was validated using data from 421 children, showing strong associations between children's self-reported anxiety, parent reports, and observed distress during medical procedures.

The results indicate that the CAM-S is an effective tool for assessing anxiety in children in busy clinical settings, which can help in developing tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a clinically useful measure of children's state anxiety before medical procedures. Ersig, AL., Kleiber, C., McCarthy, AM., et al.[2021]

Cognitive Behavioral Therapy (CBT), particularly exposure therapy, is recognized as the gold standard for treating anxiety disorders in children and adolescents, supported by strong empirical evidence.

The cognitive behavioral model provides a solid theoretical foundation for understanding and effectively treating childhood anxiety, making it a reliable approach for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Children and Adolescents with Anxiety Disorders. Stiede, JT., Trent, ES., Viana, AG., et al.[2023]

In a study involving 488 participants aged 7 to 17, no significant differences in adverse events (AEs) were found between sertraline (an SSRI) and placebo, indicating that sertraline is generally safe for treating anxiety disorders in children and adolescents.

However, children (aged 12 and under) reported higher rates of psychiatric AEs across all treatment conditions, suggesting that closer monitoring for these side effects is necessary in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child/Adolescent anxiety multimodal study: evaluating safety. Rynn, MA., Walkup, JT., Compton, SN., et al.[2022]

Clonazepam is being studied as a potential treatment for childhood anxiety disorders due to its effectiveness in reducing panic attacks in adults and its minimal serious side effects.

While some side effects like drowsiness and irritability have been reported in studies of clonazepam for seizures, these were often linked to rapid dosage increases, suggesting that careful dosing may mitigate risks in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High anxiety in children. Graae, F.[2013]

Anxiety disorders affect up to 30% of adolescents, and traditional treatments based on adult extinction learning may not be suitable due to developmental differences in brain circuitry.

Safety signal learning, which uses cues to indicate safety and reduce fear responses, shows promise as a novel intervention for anxious youths, potentially improving treatment outcomes by aligning with the unique developmental trajectory of their brains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning About Safety: Conditioned Inhibition as a Novel Approach to Fear Reduction Targeting the Developing Brain. Odriozola, P., Gee, DG.[2021]

Children and adolescents with anxiety disorders often experience heightened anxiety in response to normal developmental activities, leading to avoidance behaviors that can worsen their condition.

Effective interventions focus on treating anxiety symptoms to remission, encouraging engagement in developmental activities, and rewarding positive coping strategies while avoiding reinforcement of avoidance behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dysregulation, Catastrophic Reactions, and the Anxiety Disorders. Walkup, JT., Friedland, SJ., Peris, TS., et al.[2021]

In a clinical trial involving 62 children under 4 years old undergoing a CT scan, listening to nursery songs with heartbeat sounds significantly reduced anxiety levels, as indicated by a 1.6 cm improvement on the visual analog scale (VAS) compared to a worsening in the control group.

The intervention was associated with a 3.2 times higher likelihood of improved sedation scores, suggesting that this music-based approach could be an effective non-pharmacological method to help manage anxiety in young children during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized single-blinded clinical trial on effects of nursery songs for infants and young children's anxiety before and during head computed tomography. Park, G., Weiss, SJ., Repar, P.[2016]

The pilot study involving 225 participants from three schools in Australia found that an online anxiety prevention program was acceptable and feasible to implement in a school setting.

While the program did not show significant reductions in anxiety symptoms compared to a control group, some effect sizes were consistent with previous research, suggesting that further investigation in larger trials is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of the e-couch anxiety and worry program in schools. Calear, AL., Christensen, H., Brewer, J., et al.[2020]

Parent-child interaction therapy (PCIT) has been successfully adapted to help treat anxiety disorders in children aged 7 and younger, who typically lack the cognitive skills needed for traditional cognitive behavioral therapy.

Two specific adaptations of PCIT have been developed: one for separation anxiety and another called the CALM Program, which addresses a variety of early childhood anxiety disorders, highlighting the flexibility and effectiveness of PCIT in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting parent-child interaction therapy to treat anxiety disorders in young children. Puliafico, AC., Comer, JS., Pincus, DB.[2019]

In a study involving 132 primary school children, those who underwent 12 sessions of relaxation training showed a significant improvement in short-term memory compared to those who had only 6 sessions or no training at all.

The study highlighted that a large percentage of children reported high levels of stress (49%), anxiety (80%), and depression (61%), suggesting that relaxation training could be a beneficial intervention for improving emotional well-being in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in emotional distress, short term memory, and sustained attention following 6 and 12 sessions of progressive muscle relaxation training in 10-11 years old primary school children. Hashim, HA., Zainol, NA.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: Development of the CALM Intervention. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Utility of relaxation training with children in school settings: a plea for realistic goal setting and evaluation. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Educational Video on Pre-operative Anxiety in Children - A Randomized Controlled Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Validation of a clinically useful measure of children's state anxiety before medical procedures. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Children and Adolescents with Anxiety Disorders. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Child/Adolescent anxiety multimodal study: evaluating safety. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

High anxiety in children. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Learning About Safety: Conditioned Inhibition as a Novel Approach to Fear Reduction Targeting the Developing Brain. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Dysregulation, Catastrophic Reactions, and the Anxiety Disorders. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Randomized single-blinded clinical trial on effects of nursery songs for infants and young children's anxiety before and during head computed tomography. [2016]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of the e-couch anxiety and worry program in schools. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Adapting parent-child interaction therapy to treat anxiety disorders in young children. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Changes in emotional distress, short term memory, and sustained attention following 6 and 12 sessions of progressive muscle relaxation training in 10-11 years old primary school children. [2015]