NCT03899948

Brief Summary

The purpose of the study is to compare two teacher trainings developed to assist elementary students who struggle with excessive anxiety. The goal of both teacher trainings is to improve teachers' knowledge and skills for identifying and assisting students with excessive anxiety. The first training program is called TAPES (Teacher Anxiety Program for Elementary Students) and involves a 6 hour teacher training. Teachers in this training program will implement anxiety reduction skills in the classroom and complete 5 brief (approximately 30 minute) meetings with the student and his or her parent(s)/guardian(s). The second training program, Teacher Anxiety Training (TAT), involves a 3 hour teacher training. Teachers in the TAT condition learn to implement anxiety reduction skills in the classroom, but do not conduct individual meetings with parents and students. The investigators do not know if TAT and TAPES work equally well, or if one is better than the other. Both will be administered by teachers to see if they help youth with excessive anxiety feel less worried.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

4.4 years

First QC Date

March 28, 2019

Last Update Submit

September 6, 2022

Conditions

Keywords

Excessive AnxietyTeacher TrainingElementary SchoolSchool-basedEffectiveness ResearchRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline on the Teacher Knowledge Assessment

    Two equivalent forms assessing teachers' knowledge of anxiety symptoms and anxiety-reduction strategies. Comprised of multiple-choice and short-answer questions.

    Baseline, 8 week Post-Intervention

  • Change from Baseline on the Classroom Observation of Teachers Skills

    This is a form created for this study that is completed by two independent evaluators following direct observations of teachers. Observers rate the teachers' use of teaching behaviors reviewed in the training. Scores are generated for 3 domains: Teacher behaviors that may decrease anxiety (Do Behaviors), behaviors that may increase anxiety (Don't Behaviors), and behaviors that evidence strong teacher-student relationships (Relationship Behaviors). Teachers are rated on a 5 point Likert-type scale, with 0 indicating poor behavior and 4 indicating very good or excellent behavior (min score = 0, max score = 4 on all domains). There is no combined total score. Higher values in each domain demonstrate greater mastery of teaching behaviors reviewed in the training.

    Baseline, 8-week post-intervention, 3-month post-intervention follow-up

Secondary Outcomes (9)

  • Change from Baseline on the Modified Anxiety Diagnostic Interview Schedule, for the Diagnostic and Statistical Manual Fifth Edition (ADIS-V)

    Baseline, 8-week post-intervention, 3-month post-intervention follow-up

  • Change from Baseline on the Spence Children's Anxiety Scale, Child and Parent Versions

    Baseline, 8-week post-intervention, 3-month post-intervention follow-up

  • Change from Baseline on the Child Anxiety Impact Scale, Child and Parent Versions (& adapted Teacher Version)

    Baseline, 8-week post-intervention, 3-month post-intervention follow-up

  • Change from Baseline on the Woodcock Johnson IV Tests of Achievement (Fluency subtests)

    Baseline, 8-week post-intervention, 3-month post-intervention follow-up

  • Change from Baseline on the Woodcock Johnson IV Tests of Cognitive Abilities (Numbers Reversed subtest)

    Baseline, 8-week post-intervention, 3-month post-intervention follow-up

  • +4 more secondary outcomes

Study Arms (2)

Teacher Anxiety Program for Elementary Students (TAPES)

EXPERIMENTAL

Teachers in the experimental condition attend a 6-hour training on the TAPES program. The teachers learn to implement a brief intervention (5 meetings) with the student and his or her parent, utilize classroom anxiety-reduction strategies, and apply relationship enhancement strategies to improve the relationship with the target student and parents.

Behavioral: Teacher Anxiety Program for Elementary Students

Teacher Anxiety Training (TAT)

ACTIVE COMPARATOR

Teachers in this condition receive training about childhood anxiety and classroom anxiety-reduction strategies using a 3-hour typical teacher professional development training format.

Behavioral: Teacher Anxiety Training

Interventions

TAPES consists of three core components: 1) training in evidenced-based anxiety reduction strategies that teachers will implement to identify and assist specific anxious students and classroom-wide strategies helpful to all students, 2) evidenced-based material for teachers to review with parents regarding how to reduce student anxiety at home, thus improving school-home communication and shared goals and 3) training in how to conduct 5 brief (30 minute) teacher-parent-student meetings to teach and practice the TAPES anxiety-reduction strategies.

Also known as: TAPES
Teacher Anxiety Program for Elementary Students (TAPES)

The TAT is a 3-hour professional development training for teachers. Training focuses on recognizing the signs and symptoms related to child anxiety and utilizing classroom-wide strategies to help reduce anxiety in the classroom.

Also known as: TAT
Teacher Anxiety Training (TAT)

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Must attend a CT elementary school
  • Must have elevated anxiety symptoms, which is defined as a total Spence Children's Anxiety Scale t score \> 60 based on parent and/or child report and/or a Clinician Severity Rating (CSR) of 3 or greater on the Anxiety Disorder Interview Schedule (ADIS-V).

You may not qualify if:

  • Any medical or psychiatric condition contraindicating the study participation (based on clinical interview; such as recent suicidality)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

West Hartford, Connecticut, 06030, United States

Location

Related Publications (9)

  • Cartwright-Hatton S, Mather A, Illingworth V, Brocki J, Harrington R, Wells A. Development and preliminary validation of the Meta-cognitions Questionnaire-Adolescent Version. J Anxiety Disord. 2004;18(3):411-22. doi: 10.1016/S0887-6185(02)00294-3.

    PMID: 15125986BACKGROUND
  • Drake KL, Ginsburg GS. Parenting Practices of Anxious and Non-Anxious Mothers: A Multi-method Multi-informant Approach. Child Fam Behav Ther. 2011;33(4):299-321. doi: 10.1080/07317107.2011.623101. Epub 2011 Dec 6.

    PMID: 22639487BACKGROUND
  • James AC, James G, Cowdrey FA, Soler A, Choke A. Cognitive behavioural therapy for anxiety disorders in children and adolescents. Cochrane Database Syst Rev. 2013 Jun 3;(6):CD004690. doi: 10.1002/14651858.CD004690.pub3.

    PMID: 23733328BACKGROUND
  • Assor A, Kaplan H, Kanat-Maymon Y, Roth G. Directly controlling teacher behaviors as predictors of poor motivation and engagement in girls and boys: The role of anger and anxiety. Learning and Instruction 15(5): 397-413, 2005.

    BACKGROUND
  • O'Connor EE, Dearing E, Collins BA. Teacher-child relationship and behavior problem trajectories in elementary school. American Educational Research Journal 48(1):120-62, 2011.

    BACKGROUND
  • Beidas RS, Kendall PC. Training Therapists in Evidence-Based Practice: A Critical Review of Studies From a Systems-Contextual Perspective. Clin Psychol (New York). 2010 Mar;17(1):1-30. doi: 10.1111/j.1468-2850.2009.01187.x.

    PMID: 20877441BACKGROUND
  • Fixsen DL, Naoom SF, Blase KA, Friedman RM. Implementation research: A synthesis of the literature. Tampa, FL: University of South Florida, Louis de la Parte Florida Mental Health Institute, The National Implementation Research Network, 2005.

    BACKGROUND
  • Sholomskas DE, Syracuse-Siewert G, Rounsaville BJ, Ball SA, Nuro KF, Carroll KM. We don't train in vain: a dissemination trial of three strategies of training clinicians in cognitive-behavioral therapy. J Consult Clin Psychol. 2005 Feb;73(1):106-15. doi: 10.1037/0022-006X.73.1.106.

    PMID: 15709837BACKGROUND
  • Ginsburg GS, Pella JE, Piselli K, Chan G. Teacher Anxiety Program for Elementary Students (TAPES): intervention development and proposed randomized controlled trial. Trials. 2019 Dec 30;20(1):792. doi: 10.1186/s13063-019-3863-9.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Golda S Ginsburg, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Independent Evaluators (IEs) conduct all post and follow-up assessments. These IEs are blind to the condition of all participants.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study uses a parallel Randomized Controlled Trial Design. Following teacher enrollment, randomization occurs at the teacher level with a 1:1 (20 TAPES condition: 20 TAT condition) ratio. Teachers in each condition complete the training and intervention concurrently.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 2, 2019

Study Start

January 18, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations