School-Based Treatment for Early Childhood Anxiety

Study Overview
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Brief Summary
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This pilot will be used for academic research, in hopes of developing effective treatments for early childhood anxiety. The intervention is an adaptation of Parent-Child Interaction Therapy (PCIT). PCIT is an evidence-based intervention, rooted in attachment and social learning theory. In recent years, researchers have successfully adapted PCIT to address anxiety in a clinical setting (PCIT-CALM). In this pilot study, we will be applying the PCIT-CALM intervention in the school setting, emphasizing teachers as a therapeutic agent of change. PCIT is unique because the child's caregiver is trained on how to use therapeutic techniques, and then receives live coaching via a bug in the ear as they learn to implement the new skills. In this pilot study, both parents and teachers will be taught skills to create a therapeutic relationship and address anxiety. After these teaching sessions, the child's teacher will receive coaching in the classroom to implement the skills. The intervention will last approximately 12 weeks.

Official Title
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A Pilot Study of a School-Based Treatment for Early Childhood Anxiety

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: TCIT-CALM (Teacher-Child Interaction Training-CALM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scores in the at-risk or clinical range for anxiety on the BASC-3 or CBCL (which will be filled out by a parent and teacher to determine eligibility) Child must be enrolled at the Montessori School of Denver where the intervention is being conducted. Exclusion Criteria: None if other criteria are met. Comorbidity will not exclude a child, but if comorbidities are discovered for which there are other evidence-based treatments available, parents will be encouraged to seek additional resources.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a pilot study in which all individuals will be enrolled in the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>This study consists of one arm, an intervention group. | Behavioral: TCIT-CALM (Teacher-Child Interaction Training-CALM)<br>* This intervention is designed to treat early childhood anxiety. It is an adaptation of parent-child interaction therapy (PCIT), in which teachers rather than parents are targeted as the therapeutic agent of change. The intervention follows the procedures of the CALM protocol, in which caregivers are taught play therapy skills to support and address anxious behaviors and avoidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring Changes in scores on Behavior Assessment System for Children (BASC-3) | A normed clinical rating scale for assessing behavior and mental health; This tool was chosen due to the norms for young children and the ability to have both parent and teacher rating scales. | Pre- treatment Baseline and immediately following the intervention; An additional data collection was later added for longitudinal data that will be collected in October. | 
| Measuring Changes in scores on Child Behavior Checklist (CBCL) | A normed clinical rating scale for assessing behavior and mental health; This tool was chosen due to the norms for young children and the ability to have both parent and teacher rating scales. | Pre- treatment Baseline and immediately following the intervention; An additional data collection was later added for longitudinal data that will be collected in October. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy Attitude Inventory | A brief questionnaire to assess how well the intervention worked for the adults involved. The questionnaire includes 10 questions with a Likert scale response (1-5; 1 indicating little value from the intervention and 5 indicating it was highly beneficial. | Immediately following the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parent-Child Interaction Therapy (PCIT), CALM Protocol, Teacher-Child Interaction Training (TCIT)