School-Based Treatment for Early Childhood Anxiety

NCT04811482 | Completed

• 1 other identifier: 21-2523
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Parent-Child Interaction Therapy (PCIT); CALM Protocol; Teacher-Child Interaction Training (TCIT)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Therapy Attitude Inventory

  Immediately following the intervention

Study Arms (1)

Intervention Group

EXPERIMENTAL

This study consists of one arm, an intervention group.

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

Interventions

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

Intervention Group

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Montessori School of Denver

Denver, Colorado, 80222, United States

Location

Related Publications (3)

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

  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.

  PMID: 22800997 BACKGROUND

• 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.

  PMID: 21917417 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Victoria Virlee

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot study in which all individuals will be enrolled in the intervention.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 23, 2021
• Study Start: March 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

US (1)