Behavior, ChildNCT04000230
Teacher Child Interaction Training (TCIT): Randomized Control Trial
A study testing TCIT and Booster in people with Behavior, Child, run by University of Miami at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child
- What is being tested?
- TCIT and Booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Jul 2017to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Debbie School
Miami, Florida, 33136
EasterSeals South Florida
Miami, Florida, 33136
Linda Ray Intervention Center
Miami, Florida, 33136
Arc of South Florida
Miami, Florida, 33173
About this study
Official title: Teacher-Child Interaction Training in Miami-Dade County Early Education Programs: A Randomized Control Trial
This study is being conducted to evaluate the effects of TCIT on child development, child behavior, and teacher use of skills in the classroom.
- Conditions
- Behavior, Child
- Being tested
- TCIT, Booster
- Keywords
- Early Education Program, Developmental Delay, Behavior Management, Social Emotional Development, Special Education
- Medical subject headings
- Child Behavior, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCITBehavioural
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.
BoosterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: TCIT; Behavioral: 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. Receives: Behavioral: TCIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months
Secondary outcomes (2)
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.
Measured: 8 months
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).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start7 Jul 2017
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Trust, Miami FL
- Responsible party
- Principal investigator, Eileen Davis, University of Miami
- Investigators
- Eileen M Davis, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000230
- Sponsor's protocol ID
- 20170372
- Status last verified
- Aug 2021
- First submitted
- 25 Jun 2019
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teacher-Child Interaction Training in Miami-Dade County Early Education Programs: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04000230
- Acronym / sponsor ID
- 20170372
- Conditions
- Behavior, Child
- Keywords
- Early Education Program, Developmental Delay, Behavior Management, Social Emotional Development, Special Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Children's Trust, Miami FL
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the effects of TCIT on child development, child behavior, and teacher use of skills in the classroom.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCIT | Experimental | Behavioral: TCIT, Behavioral: BoosterTeachers 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. |
| Waitlist Control | Active comparator | Behavioral: TCITWaitlist 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. |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCITTCIT 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. | Behavioural | TCIT, Waitlist Control |
| BoosterTeachers 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. | Behavioural | TCIT |
Primary outcome
Change in teacher use of TCIT skills
Time frame: Baseline to 8 months
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.
Student social-emotional functioning
Time frame: 8 months
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.
Child prosocial 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. 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.
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.
2 secondary outcomes
Child disruptive behaviors
Time frame: 8 months
Child language development
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen M Davis, PhD principal investigator
University of Miami
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCIT and Booster in people with Behavior, Child, run by University of Miami at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in teacher use of TCIT skills (time frame: Baseline to 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.