Clinical trial NCT04811482: School-Based Treatment for Early Childhood Anxiety
Official title: A Pilot Study of a School-Based Treatment for Early Childhood Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Parent-Child Interaction Therapy (PCIT)
CALM Protocol
Teacher-Child Interaction Training (TCIT)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 7
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot study in which all individuals will be enrolled in the intervention.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Measuring Changes in scores on Behavior Assessment System for Children (BASC-3)
timeFrame: Pre- treatment Baseline and immediately following the intervention; An additional data collection was later added for longitudinal data that will be collected in October.
measure: Measuring Changes in scores on Child Behavior Checklist (CBCL)
timeFrame: 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:
measure: Therapy Attitude Inventory
timeFrame: Immediately following the intervention
Other outcomes:
Locations:
city: Denver
country: United States
facility: Montessori School of Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Victoria Virlee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puliafico, A. C., Furr, J. M., Hong, N, & Comer, J. S. (2020). The CALM program for early childhood anxiety: Version 2.0.
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.
citation: 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.