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Teacher Anxiety Program for Elementary Students (TAPES)

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ClinicalTrials.gov Identifier: NCT03899948
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Golda S. Ginsburg, UConn Health

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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Teacher Anxiety Program for Elementary Students Behavioral: Teacher Anxiety Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: Independent Evaluators (IEs) conduct all post and follow-up assessments. These IEs are blind to the condition of all participants.
Primary Purpose: Other
Official Title: Teacher Anxiety Program for Elementary Students
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Teacher Anxiety Program for Elementary Students (TAPES)
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
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.
Other Name: TAPES

Active Comparator: Teacher Anxiety Training (TAT)
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
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.
Other Name: TAT




Primary Outcome Measures :
  1. Change from Baseline on the Teacher Knowledge Assessment [ Time Frame: Baseline, 8 week Post-Intervention ]
    Two equivalent forms assessing teachers' knowledge of anxiety symptoms and anxiety-reduction strategies. Comprised of multiple-choice and short-answer questions.

  2. Change from Baseline on the Classroom Observation of Teachers Skills [ Time Frame: Baseline, 8-week post-intervention, 3-month post-intervention follow-up ]
    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.


Secondary Outcome Measures :
  1. Change from Baseline on the Modified Anxiety Diagnostic Interview Schedule, for the Diagnostic and Statistical Manual Fifth Edition (ADIS-V) [ Time Frame: Baseline, 8-week post-intervention, 3-month post-intervention follow-up ]
    Semi-structured clinical interview assessing student anxiety diagnosis and severity.

  2. Change from Baseline on the Spence Children's Anxiety Scale, Child and Parent Versions [ Time Frame: Baseline, 8-week post-intervention, 3-month post-intervention follow-up ]
    The Spence Children's Anxiety Scale is a reliable and valid measure of anxiety symptoms in children. Both versions use a 4-point Likert scale to assess frequency of symptoms (0 = never, 3 = always). The child report has 44 items--38 of which are used to calculate the total score. The parent report has a total of 39 items--38 of which are used in the total score (minimum score 0 , maximum score 114). On both forms, higher scores represent higher levels of anxiety.

  3. Change from Baseline on the Child Anxiety Impact Scale, Child and Parent Versions (& adapted Teacher Version) [ Time Frame: Baseline, 8-week post-intervention, 3-month post-intervention follow-up ]
    The Child Anxiety Impact Scale measures the impact of a child's anxiety across school, home, and social domains. Both versions use a 4-point Likert scale (0 = not at all, 3 = very much) to assess the frequency of anxiety impairment in various areas. The range for the total score is 0 (minimum) to 81 (maximum). Subscale scores range from a minimum of 0 to a maximum of 30, 33, and 18 for the school, social, and home subscales, respectively. Higher scores represent greater interference of anxiety in child functioning.

  4. Change from Baseline on the Woodcock Johnson IV Tests of Achievement (Fluency subtests) [ Time Frame: Baseline, 8-week post-intervention, 3-month post-intervention follow-up ]
    Psychometrically validated measure of academic fluency in children. Scores are generated as standard scores with a mean of 100 and a standard deviation of 15. Higher scores represent better academic performance.

  5. Change from Baseline on the Woodcock Johnson IV Tests of Cognitive Abilities (Numbers Reversed subtest) [ Time Frame: Baseline, 8-week post-intervention, 3-month post-intervention follow-up ]
    Psychometrically validated measure of working memory in children. Scores are generated as standard scores with a mean of 100 and a standard deviation of 15. Higher scores represent better working memory capacity.

  6. Change from Baseline on the Family Accommodation Scale, Anxiety (FASA) Parent form (& adapted teacher version) [ Time Frame: Baseline, 8-week post-intervention, 3-month post-intervention follow-up ]
    Measures frequency of parent (and teacher) accommodation behaviors in relation to child's anxiety symptoms. Items are rated on a 5-point Likert scale (0 = Never, 4 = Daily). Items 1-9 are summed to find total accommodation behaviors (minimum score = 0, maximum score = 36). Higher scores represent more accommodation behaviors associated with more anxiety-related impairment in family functioning or classroom functioning.

  7. Change from Baseline on the Children's Global Assessment Scale (CGAS) [ Time Frame: Baseline, 8-week post-intervention, 3-month post-intervention follow-up ]
    The Children's Global Assessment Scale is a single-item measure of child's overall behavioral functioning assigned by a clinical interviewer. Scores on this scale range from 1 to 100. Higher scores are associated with more adaptive functioning. More specifically, scores below 70 are indicative of increasingly severe impairment in behavioral functioning.

  8. Change from Baseline on the Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) Scales [ Time Frame: Baseline, 8-week post-intervention, 3-month post-intervention follow-up ]
    These two single-item scales measure a student's anxiety symptom severity and improvement as rated by a clinical interviewer. On the Severity scale, scores range from 1 (Normal) to 7 (Extremely Ill). Higher scores represent greater anxiety symptom severity. On the Improvement scale, scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores represent better outcomes relative to the baseline assessment.

  9. Change from Baseline on the School Anxiety Scale [ Time Frame: Baseline, 8-week post-intervention, 3-month post-intervention follow-up ]
    The School Anxiety Scale is a teacher-report measure of anxiety symptoms exhibited in the classroom. This 16-item measure uses a 4-point Likert scale to measure the frequency of anxiety-related behaviors (0 = never, 3 = always). The scale has a minimum score of 0, and a maximum score of 48. Higher scores represent more frequent anxiety-related behaviors in the classroom.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899948


Contacts
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Contact: Golda S Ginsburg, PhD 8605233788 gginsburg@uchc.edu
Contact: Jeffrey E Pella, PhD 8605236476 pella@uchc.edu

Locations
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United States, Connecticut
University of Connecticut Health Center Recruiting
West Hartford, Connecticut, United States, 06030
Contact: Golda S Ginsburg, Ph.D.    860-523-3788    gginsburg@uchc.edu   
Contact: Jeffrey E Pella, Ph.D.    860-523-6476    pella@uchc.edu   
Principal Investigator: Golda S. Ginsburg, PhD         
Sponsors and Collaborators
UConn Health
Investigators
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Principal Investigator: Golda S Ginsburg, PhD UConn Health
  Study Documents (Full-Text)

Documents provided by Golda S. Ginsburg, UConn Health:

Publications:
Ginsburg GS, Burstein M, Becker KD, Drake KL. Treatment of obsessive compulsive disorder in young children: An intervention model and case series. Child & Family Behavior Therapy 33(2): 97-122, 2011.
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.
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.
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.

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Responsible Party: Golda S. Ginsburg, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT03899948     History of Changes
Other Study ID Numbers: R324A170071
R324A170071 ( Other Grant/Funding Number: Institute of Education Sciences )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Golda S. Ginsburg, UConn Health:
Excessive Anxiety
Teacher Training
Elementary School
School-based
Effectiveness Research
Randomized Controlled Trial

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders