School-Based Treatment for Early Childhood Anxiety

NCT ID: NCT04811482

Last Updated: 2022-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-11-01

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.

Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a pilot study in which all individuals will be enrolled in the intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

This study consists of one arm, an intervention group.

Group Type EXPERIMENTAL

TCIT-CALM (Teacher-Child Interaction Training-CALM)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria Virlee

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Montessori School of Denver

Denver, Colorado, United States

Site Status

Countries

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United States

References

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Puliafico, A. C., Furr, J. M., Hong, N, & Comer, J. S. (2020). The CALM program for early childhood anxiety: Version 2.0.

Reference Type BACKGROUND

Puliafico AC, Comer JS, Pincus DB. Adapting parent-child interaction therapy to treat anxiety disorders in young children. Child Adolesc Psychiatr Clin N Am. 2012 Jul;21(3):607-19. doi: 10.1016/j.chc.2012.05.005. Epub 2012 Jun 2.

Reference Type BACKGROUND
PMID: 22800997 (View on PubMed)

Comer JS, Puliafico AC, Aschenbrand SG, McKnight K, Robin JA, Goldfine ME, Albano AM. A pilot feasibility evaluation of the CALM Program for anxiety disorders in early childhood. J Anxiety Disord. 2012 Jan;26(1):40-9. doi: 10.1016/j.janxdis.2011.08.011. Epub 2011 Aug 25.

Reference Type BACKGROUND
PMID: 21917417 (View on PubMed)

Other Identifiers

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21-2523

Identifier Type: -

Identifier Source: org_study_id

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