CALM Intervention for Childhood Anxiety Disorder
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byGolda S Ginsburg, Ph.D.
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: UConn Health
Disqualifiers: Non-English speakers, others
No Placebo Group
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.12345
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.678910
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.12111213
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.
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Trial 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) (Behavioural Intervention)
- Child Anxiety Learning Modules--Relaxation (CALM-R) (Behavioural Intervention)
Trial OverviewThe 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
3Treatment groups
Experimental Treatment
Active Control
Group I: Child Anxiety Learning Modules (CALM)Experimental Treatment1 Intervention
Children randomly assigned to this condition will receive the CALM intervention.
Group II: Waitlist controlActive Control1 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 Control1 Intervention
Children randomly assigned to this condition will receive the CALM-R intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Connecticut School of MedicineWest Hartford, CT
Anxiety Treatment Center of MarylandColumbia, MD
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Who Is Running the Clinical Trial?
UConn HealthLead Sponsor
References
Enhancing the Capacity of School Nurses to Reduce Excessive Anxiety in Children: Development of the CALM Intervention. [2023]Excessive anxiety is among the most common psychiatric problems facing youth. Because anxious youth tend to have somatic complaints, many seek help from the school nurse. Thus, school nurses are in an ideal position to provide early intervention. This study addresses this problem and describes the plans to develop and test a new intervention (Child Anxiety Learning Modules; CALM), delivered by school nurses, to reduce child anxiety and improve academic functioning.
Utility of relaxation training with children in school settings: a plea for realistic goal setting and evaluation. [2019]School-based relaxation training programmes are a popular means of helping children with anxiety problems such as headaches and test anxiety.
Effects of Educational Video on Pre-operative Anxiety in Children - A Randomized Controlled Trial. [2021]Objective: Audio-visual interventions have been used to provide relevant patient information to reduce pre-operative anxiety in children. The aim of the study was to investigate whether self-reported state anxiety in children could be reduced by presenting a child-friendly educational video on the day of surgery. Methods: A prospective, single-blinded, two-armed, randomized controlled study was designed with three measurement time points including 90 children (6-17 years) and their parents. In the intervention group (IG), the children and their parents were shown a child-friendly video explaining the perioperative procedures that would be applied during the hospital stay, in addition to receiving standard information. In the control group (CG), children and parents received standard information provided by the nursing staff. The primary outcome was any change in the children's pre-operative state anxiety levels, as measured by the State-Trait Operation Anxiety Inventory (STOA). A secondary outcome was patient satisfaction regarding the received information. Results: Anxiety was significantly reduced in both groups after receiving either the intervention plus standard information or the standard information only. No significant difference in anxiety reduction was observed between the IG and the CG. However, the children and parents in the IG reported fewer worries than those in the CG. Conclusion: A child-friendly, educational video can be an additional tool for providing patient information and reducing pre-operative anxiety in children and their parents. Further studies should focus on the timing of the intervention and on age- and developmentally appropriate information formats and contents to address children's pre-operative anxiety. Clinical Trial Registration: Patient Anxiety Reduction in Children by Using Simple Explanation Videos, ID: NCT0441377; www.clinicaltrials.gov, Data Sharing Statement: Deidentified individual participant data will not be made available.
Validation of a clinically useful measure of children's state anxiety before medical procedures. [2021]Assessment of children's anxiety in busy clinic settings is an important step in developing tailored interventions. This article describes the construct validation of the Children's Anxiety Meter-State (CAM-S), a brief measure of state anxiety.
Cognitive Behavioral Therapy for Children and Adolescents with Anxiety Disorders. [2023]Anxiety disorders are the most common class of psychiatric conditions among children and adolescents. The cognitive behavioral model of childhood anxiety has a strong theoretic and empirical foundation that provides the basis for effective treatment. Cognitive behavioral therapy (CBT), with an emphasis on exposure therapy, is the gold standard treatment for childhood anxiety disorders, with strong empirical support. A case vignette demonstrating CBT for childhood anxiety disorders in practice, as well as recommendations for clinicians, are also provided.
Child/Adolescent anxiety multimodal study: evaluating safety. [2022]To evaluate the frequency of adverse events (AEs) across 4 treatment conditions in the Child/Adolescent Anxiety Multimodal Study (CAMS), and to compare the frequency of AEs between children and adolescents.
High anxiety in children. [2013]Although reliable biological markers of dysfunctional childhood anxiety disorders are lacking, such disorders can be recognized by their symptoms. In separation anxiety and avoidance disorders, anxiety is limited to certain settings; in overanxious disorder, anxiety is generalized. Treatment for childhood anxiety disorders has included behavioral and pharmacologic intervention alone or in combination, but evidence of the efficacy of medical treatment is sparse. Some antidepressants and benzodiazepines have undergone limited studies. Clonazepam has been chosen for further study because in adults it reduced panic attacks and produced few serious side effects. In extensive studies of clonazepam for childhood seizure disorders, side effects were reported, but later reports indicate that many side effects were due to rapid induction and large doses. Transient drowsiness, lethargy, irritability, or excitability have been reported in various epilepsy studies. Clonazepam's minimal potential for drug interactions is another feature recommending it for extended trials in childhood anxiety disorders, and such a double-blind crossover study is underway.
Learning About Safety: Conditioned Inhibition as a Novel Approach to Fear Reduction Targeting the Developing Brain. [2021]Adolescence is a peak time for the onset of psychiatric disorders, with anxiety disorders being the most common and affecting as many as 30% of youths. A core feature of anxiety disorders is difficulty regulating fear, with evidence suggesting deficits in extinction learning and corresponding alterations in frontolimbic circuitry. Despite marked changes in this neural circuitry and extinction learning throughout development, interventions for anxious youths are largely based on principles of extinction learning studied in adulthood. Safety signal learning, based on conditioned inhibition of fear in the presence of a cue that indicates safety, has been shown to effectively reduce anxiety-like behavior in animal models and attenuate fear responses in healthy adults. Cross-species evidence suggests that safety signal learning involves connections between the ventral hippocampus and the prelimbic cortex in rodents or the dorsal anterior cingulate cortex in humans. Particularly because this pathway follows a different developmental trajectory than fronto-amygdala circuitry involved in traditional extinction learning, safety cues may provide a novel approach to reducing fear in youths. In this review, the authors leverage a translational framework to bring together findings from studies in animal models and humans and to bridge the gap between research on basic neuroscience and clinical treatment. The authors consider the potential application of safety signal learning for optimizing interventions for anxious youths by targeting the biological state of the developing brain. Based on the existing cross-species literature on safety signal learning, they propose that the judicious use of safety cues may be an effective and neurodevelopmentally optimized approach to enhancing treatment outcomes for youths with anxiety disorders.
Dysregulation, Catastrophic Reactions, and the Anxiety Disorders. [2021]Normal developmental activities (eg, going to school, raising a hand in class, and managing typical life uncertainties) are 'triggers' for children and adolescents with anxiety disorders. To cope, children with anxiety avoid; however, when avoidance of developmentally appropriate activities is not possible, catastrophic responses can ensue. If these catastrophic reactions result in successful avoidance, they are likely to recur leading to a generalized pattern of dysregulated behavior. Interventions include treating anxiety disorder symptoms to remission. For parents the goal is to challenge their child to engage in important developmental activities, reward positive coping and avoid reinforcing avoidance behavior.
Randomized single-blinded clinical trial on effects of nursery songs for infants and young children's anxiety before and during head computed tomography. [2016]The objective of this clinical trial was to determine if an intervention of listening to nursery songs with integrated heartbeat sounds resulted in changes in anxiety levels in infants and children younger than 4 years in an emergent setting.
A pilot randomized controlled trial of the e-couch anxiety and worry program in schools. [2020]The aim of this pilot study was to evaluate the acceptability and feasibility of delivering an online anxiety prevention program in schools, and to assess the effectiveness of the intervention in reducing symptoms of anxiety. Three schools located in South Australia and the Australian Capital Territory were recruited to participate in the trial, with classes randomly allocated to the intervention or wait-list control condition. All participants (N = 225) were invited to complete a pre-intervention, post-intervention and 3-month follow-up questionnaire. Participants in the intervention condition completed the online e-couch Anxiety and Worry program during one class period a week for six weeks. No significant differences were found between the intervention and control conditions at post-intervention or 3-month follow-up for generalised anxiety (Cohen's d = - 0.09-0.08), social anxiety (d = 0.09 & - 0.26), anxiety sensitivity (d = 0.19 & - 0.15), depressive symptoms (d = 0.01 & 0.08) or mental wellbeing (d = 0.17 & 0.30). Online anxiety prevention programs are acceptable and can be feasibly delivered in schools. Although not significant, the sizes of some of the effects obtained in this pilot trial are consistent with earlier studies, and warrant further investigation in a larger trial.
Adapting parent-child interaction therapy to treat anxiety disorders in young children. [2019]Anxiety disorders are prevalent in children 7 years and younger; however, these children generally do not possess developmental skills required in cognitive behavior treatment. Recent efforts have adapted parent-child interaction therapy (PCIT), originally developed for disruptive and noncompliant behavior, for young children with anxiety. This article reviews the principles underlying PCIT and the rationale for adapting it to target anxiety symptoms. The authors describe two related treatment approaches that have modified PCIT to treat anxiety: (1) Pincus and colleagues' treatment for separation anxiety, and (2) Puliafico, Comer, and Albano's CALM Program for the range of early child anxiety disorders.
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]This study compared the effects of 6 and 12 sessions of relaxation training on emotional distress, short-term memory, and sustained attention in primary school children.