Behavior, Child Clinical Trial
Official title:
Teacher-Child Interaction Training in Miami-Dade County Early Education Programs: A Randomized Control Trial
NCT number | NCT04000230 |
Other study ID # | 20170372 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 7, 2017 |
Est. completion date | July 30, 2021 |
Verified date | August 2021 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is being conducted to evaluate the effects of TCIT on child development, child behavior, and teacher use of skills in the classroom.
Status | Completed |
Enrollment | 622 |
Est. completion date | July 30, 2021 |
Est. primary completion date | July 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Arc of South Florida | Miami | Florida |
United States | Debbie School | Miami | Florida |
United States | EasterSeals South Florida | Miami | Florida |
United States | Linda Ray Intervention Center | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | The Children's Trust |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in teacher use of TCIT skills | 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. | Baseline to 8 months | |
Primary | Student social-emotional functioning | 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. | 8 months | |
Primary | Child prosocial behaviors | 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 | |
Primary | Child disruptive/maladaptive behaviors | 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 | |
Secondary | Child disruptive behaviors | 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. | 8 months | |
Secondary | Child language development | 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). | 8 months |
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