- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04000230
Teacher Child Interaction Training (TCIT): Randomized Control Trial
Teacher-Child Interaction Training in Miami-Dade County Early Education Programs: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Florida
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Miami, Florida, United States, 33136
- Debbie School
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Miami, Florida, United States, 33136
- EasterSeals South Florida
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Miami, Florida, United States, 33136
- Linda Ray Intervention Center
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Miami, Florida, United States, 33173
- Arc of South Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- UMTCIT will target classrooms of children ages 1-5 enrolled in four participating B-2 Early Education Programs in Miami-Dade County: Debbie School, Easterseals South Florida, Arc of South Florida, and Linda Ray Intervention Center. Participants will also include school staff (teachers, teaching assistants, physical therapists, occupational therapists, speech/language pathologists) and students.
Exclusion Criteria:
- Children will be excluded from the study if they are 6 years of age or older or younger than 12 months of age at the start of each wave of treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TCIT
Teachers in the intervention group receive TCIT in the first half of the school year and booster coaching is provided throughout the second half of the school year as the Waitlist Control group is trained.
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TCIT consists of the following:
Teachers in the Intervention group will receive additional booster sessions during the second half of the school year.
Booster sessions consist of coaching teachers in CDI and TDI skills.
Teachers receive 4-8 booster sessions.
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Active Comparator: Waitlist Control
Waitlist Control teachers do not receive any intervention for the first half of the school year.
They then receive the same TCIT training as the intervention group in the second half of the school year.
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TCIT consists of the following:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in teacher use of TCIT skills
Time Frame: Baseline to 8 months
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Teacher-Child Interaction Coding System (TCICS) in a behavioral coding system that allows trained observers to tally the occurrence of certain teacher behaviors.
For CDI skills, if teachers use the skills at a frequency of 5 or more each, they have demonstrated proficiency.
If they use the skills at a frequency of 7 or more each, they have demonstrated mastery.
For TDI skills, percent correct follow-up of commands and questions at a rate of 50% demonstrates proficiency.
Percent correct follow-up at a rate of 75% demonstrates mastery.
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Baseline to 8 months
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Student social-emotional functioning
Time Frame: 8 months
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The Devereux Early Childhood Assessment (DECA) identifies each domain as an area of strength (T-score >=60), an area of need (T-score <=40), or an area of typical functioning (T-score = 41-59).
DECA t-scores range from 28 to 72 with higher scores indicating higher functioning.
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8 months
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Child prosocial behaviors
Time Frame: 8 months
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The Behavior Assessment System for Children, Third Edition - Student Observation System (BASC-3 SOS) is a behavioral observation coding system that allows for interval recording of a wide range of child positive and negative behaviors that may promote or impede learning and adjustment in the classroom. For the Adaptive Behaviors scale, there are 4 behaviors rated across 30 intervals, for a total possible score of 120 (range 0-120). Higher scores on the Adaptive Behaviors scale are indicative of higher functioning. |
8 months
|
Child disruptive/maladaptive behaviors
Time Frame: 8 months
|
The Behavior Assessment System for Children, Third Edition - Student Observation System (BASC-3 SOS) is a behavioral observation coding system that allows for interval recording of a wide range of child positive and negative behaviors that may promote or impede learning and adjustment in the classroom. The Problem Behaviors scale consists of 10 behaviors rated across 30 intervals, for a total possible score of 300 (range 0-300). Higher scores on the Problem Behaviors scale are indicative of poorer functioning. |
8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child disruptive behaviors
Time Frame: 8 months
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The Sutter-Eyberg Student Behavior Inventory-Related (SESBI-R) is a teacher rating scale of disruptive behavior of children.
It is a 38-item questionnaire with each item scored from 1 (never) to 7 (always) for a total scoring range of 38-266.
The higher score indicates increased child's disruptive behavior in the classroom setting.
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8 months
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Child language development
Time Frame: 8 months
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Assess early language based on the MacArthur Communicative Development Inventories (CDI).
It is comprised of an 89-word vocabulary checklist.
The score is assessed in the amount of correct answers and measured in percentiles, from less than 1 to 100, depending on the child's age.
Higher percentile scores indicate a higher vocabulary (i.e., more language) and lower percentile scores indicate a lower vocabulary (i.e., less language).
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8 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eileen M Davis, PhD, University of Miami
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20170372
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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