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Clinical Trials/NCT04811482
NCT04811482
Completed
N/A

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

University of Colorado, Denver1 site in 1 country7 target enrollmentMarch 1, 2021
ConditionsAnxiety

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of Colorado, Denver
Enrollment
7
Locations
1
Primary Endpoint
Measuring Changes in scores on Behavior Assessment System for Children (BASC-3)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
November 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Measuring Changes in scores on Behavior Assessment System for Children (BASC-3)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Therapy Attitude Inventory(Immediately following the intervention)

Study Sites (1)

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