School-Based Treatment for Early Childhood Anxiety

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811482
• Other study ID #: 21-2523
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: February 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Montessori School of Denver	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Therapy Attitude Inventory	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.	Immediately following the intervention