NCT04000230

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
622

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

July 7, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

4.1 years

First QC Date

June 25, 2019

Last Update Submit

August 2, 2021

Conditions

Keywords

Early Education ProgramDevelopmental DelayBehavior ManagementSocial Emotional DevelopmentSpecial Education

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Child disruptive behaviors

    8 months

  • Child language development

    8 months

Study Arms (2)

TCIT

EXPERIMENTAL

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.

Behavioral: TCITBehavioral: Booster

Waitlist Control

ACTIVE COMPARATOR

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.

Behavioral: TCIT

Interventions

TCITBEHAVIORAL

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.

TCITWaitlist Control
BoosterBEHAVIORAL

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.

TCIT

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Debbie School

Miami, Florida, 33136, United States

Location

EasterSeals South Florida

Miami, Florida, 33136, United States

Location

Linda Ray Intervention Center

Miami, Florida, 33136, United States

Location

Arc of South Florida

Miami, Florida, 33173, United States

Location

MeSH Terms

Conditions

Child BehaviorLearning Disabilities

Interventions

Immunization, Secondary

Condition Hierarchy (Ancestors)

BehaviorCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Eileen M Davis, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Pediatrics

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 27, 2019

Study Start

July 7, 2017

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations