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School-Based Treatment for Early Childhood Anxiety

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT04811482
Collaborator
(none)
7
Enrollment
1
Location
1
Arm
8
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: TCIT-CALM (Teacher-Child Interaction Training-CALM)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a pilot study in which all individuals will be enrolled in the intervention.This is a pilot study in which all individuals will be enrolled in the intervention.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of a School-Based Treatment for Early Childhood Anxiety
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

This study consists of one arm, an intervention group.

Behavioral: TCIT-CALM (Teacher-Child Interaction Training-CALM)
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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montessori School of Denver Denver Colorado United States 80222

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

  • Principal Investigator: Victoria Virlee, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT04811482
Other Study ID Numbers:
  • 21-2523
First Posted:
Mar 23, 2021
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Colorado, Denver
Parent-Child Interaction Therapy (PCIT)
CALM Protocol
Teacher-Child Interaction Training (TCIT)
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of Feb 24, 2022