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School-Based Treatment for Early Childhood Anxiety

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04811482
Enrollment
7
Registered
2021-03-23
Start date
2021-03-01
Completion date
2021-11-01
Last updated
2022-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

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

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.

Interventions

BEHAVIORALTCIT-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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
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.
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

MeasureTime frameDescription
Therapy Attitude InventoryImmediately following the interventionA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026