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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2021
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being conducted to evaluate the effects of TCIT on child development, child behavior, and teacher use of skills in the classroom.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
TCIT
TCIT consists of the following: CDI Teach Session: Teachers will participate in two training workshops in Child-Directed Interaction (CDI) skills. Specifically, teachers will learn to use positive attention skills and active ignoring. CDI Coaching: Teachers will receive 90 minutes of CDI coaching in the classroom once or twice weekly for 6 total coaching sessions over a period of 4-6 weeks. The coach will observe the class and coach the teacher live using a microphone and bug-in-the-ear device. TDI Teach Session: Teachers will complete two training workshops in Teacher Directed Interaction (TDI) skills, which focus on increasing compliance and reducing disruptive behavior. Teachers will learn to present developmentally appropriate, direct, and clear instructions and consistent positive and negative consequences. TDI Coaching: Teachers will receive six 90-minute TDI coaching sessions once or twice weekly for 4-6 weeks.
Booster
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.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Miami The Children's Trust

Country where clinical trial is conducted

United States, 

Outcome

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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