AnxietyNCT04811482
School-Based Treatment for Early Childhood Anxiety
A study testing TCIT-CALM (Teacher-Child Interaction Training-CALM) in people with Anxiety, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- TCIT-CALM (Teacher-Child Interaction Training-CALM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of a School-Based Treatment for Early Childhood Anxiety
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
- Being tested
- TCIT-CALM (Teacher-Child Interaction Training-CALM)
- Keywords
- Parent-Child Interaction Therapy (PCIT), CALM Protocol, Teacher-Child Interaction Training (TCIT)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCIT-CALM (Teacher-Child Interaction Training-CALM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This study consists of one arm, an intervention group. Receives: Behavioral: TCIT-CALM (Teacher-Child Interaction Training-CALM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Immediately following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study in which all individuals will be enrolled in the intervention.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Virlee, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811482
- Sponsor's protocol ID
- 21-2523
- Status last verified
- Feb 2022
- First submitted
- 18 Mar 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently, there is no plan to share IPD, but if data would be useful to others it has not been ruled out.
Publications
Puliafico, A. C., Furr, J. M., Hong, N, & Comer, J. S. (2020). The CALM program for early childhood anxiety: Version 2.0.
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.
PubMed 22800997Comer 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.
PubMed 21917417
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a School-Based Treatment for Early Childhood Anxiety
- ClinicalTrials.gov ID
- NCT04811482
- Acronym / sponsor ID
- 21-2523
- Conditions
- Anxiety
- Keywords
- Parent-Child Interaction Therapy (PCIT), CALM Protocol, Teacher-Child Interaction Training (TCIT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study in which all individuals will be enrolled in the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: TCIT-CALM (Teacher-Child Interaction Training-CALM)This study consists of one arm, an intervention group. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Group |
Primary outcome
Measuring Changes in scores on Behavior Assessment System for Children (BASC-3)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Therapy Attitude Inventory
Time frame: Immediately following the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- BackgroundPuliafico, A. C., Furr, J. M., Hong, N, & Comer, J. S. (2020). The CALM program for early childhood anxiety: Version 2.0.
- Background: PubMed 22800997Puliafico 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.
- Background: PubMed 21917417Comer 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.
- Individual participant dataSharing planned: Undecided. Currently, there is no plan to share IPD, but if data would be useful to others it has not been ruled out.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Virlee principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCIT-CALM (Teacher-Child Interaction Training-CALM) in people with Anxiety, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Changes in scores on Behavior Assessment System for Children (BASC-3) (time frame: Pre- treatment Baseline and immediately following the intervention; An additional data collection was later added for longitudinal data that will be collected in October.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04811482, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.