School-Based Treatment for Early Childhood Anxiety

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: TCIT-CALM (Teacher-Child Interaction Training-CALM)

• Registration Number: NCT04811482
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	TCIT-CALM (Teacher-Child Interaction Training-CALM)	This study consists of one arm, an intervention group.

Primary Outcome Measures

Name	Time	Method
Measuring Changes in scores on Behavior Assessment System for Children (BASC-3)	Pre- treatment Baseline and immediately following the intervention; An additional data collection was later added for longitudinal data that will be collected in October.	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.
Measuring Changes in scores on Child Behavior Checklist (CBCL)	Pre- treatment Baseline and immediately following the intervention; An additional data collection was later added for longitudinal data that will be collected in October.	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.

Secondary Outcome Measures

Name	Time	Method
Therapy Attitude Inventory	Immediately following the intervention	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.

Trial Locations

Locations (1)

Montessori School of Denver; 🇺🇸 Denver, Colorado, United States