A Pilot Study of Teacher-Child Interaction Training - Universal in Head Start (TCIT-U)

August 27, 2020 updated by: Children's Hospital of Philadelphia
This pilot study aims to implement and evaluate Teacher-Child Interaction Training - Universal (TCIT-U), an empirically-supported classroom-based intervention aimed at improving child behavior and social-emotional skills through strengthening teacher-child relationships at a preschool that serves children from socially and economically disadvantaged backgrounds who are at risk for behavioral health difficulties. The main objectives are to (a) examine TCIT-U's effects on teacher behavior, teachers' sense of efficacy, and child behavior problems and social-emotional skills compared to usual care (UC) and (b) explore the feasibility and acceptability of implementing TCIT-U at a diverse urban preschool.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Disruptive behaviors and social-emotional skill deficits are common problems in early education settings and contribute to the high rates of preschool suspensions and expulsions. While teachers serve a critical role in children's behavioral health, they often lack evidence-based training in strategies that could improve child behavior and promote social-emotional skills. The goal of this project is to implement and evaluate Teacher-Child Interaction Training - Universal (TCIT-U), an empirically-supported classroom-based intervention aimed at improving child behavior and social-emotional skills through strengthening teacher-child relationships at a preschool that serves children from socially and economically disadvantaged backgrounds who are at risk for behavioral health difficulties.

The main objectives are to (a) examine TCIT-U's effects on teacher behavior, teachers' sense of efficacy, and child behavior problems and social-emotional skills compared to usual care (UC) and (b) explore the feasibility and acceptability of implementing TCIT-U at a diverse urban preschool.

This pilot study is a nonrandomized clinical trial comparing TCIT-U to a UC control group at urban preschool. Teachers in the intervention group will participate in TCIT-U. TCIT-U and UC teachers will complete measures at baseline, post-intervention, and end-of-the-school-year follow-up. All teachers will be observed for their TCIT-U skill use at baseline, mid-intervention, post-intervention, and follow-up. Qualitative interviews will be conducted with educational staff at follow-up to examine feasibility and acceptability data.

Participants will be eight teachers and approximately 80 children from four preschool classrooms in Philadelphia. Educational staff will also be invited to participate in qualitative interviews. Staff must speak English to participate. There is no exclusion criteria for children.

Four teachers from two Head Start classrooms will participate in TCIT-U. TCIT-U is an empirically-supported intervention aimed at strengthening teacher-child relationships and improving child behavior and social-emotional skills. TCIT-U includes group didactic and individualized coaching sessions. Four teachers from two other classrooms will serve as the UC control group.

Teacher behavior will be coded during live classroom observations. Teacher-reported questionnaires will measure teachers' sense of efficacy and child behavior and social-emotional skills. Qualitative interviews and satisfaction surveys will explore the feasibility and acceptability of implementing TCIT-U. Fidelity checklists will be completed by the TCIT-U Trainer and expert consultants to document intervention fidelity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Teachers' Inclusion Criteria:

  • Serve as a head, co-, and/or assistant teacher in a Head Start or PreK Counts classroom at the participating early childhood education center.
  • Speak and read English proficiently.
  • Provide written informed consent.

Teachers' Exclusion Criteria: Do not speak and read English proficiently.

Children's Inclusion Criteria:

  • Enrolled in one of the participating Head Start or PreK Counts classrooms prior to baseline evaluations.
  • Aged 3 through 5 years old.
  • Provided an informational letter about the study to their parents.

Children's Exclusion Criteria: There are no exclusion criteria for children.

Educational Staff's Inclusion Criteria (qualitative interviews):

  • Participated in or observed TCIT-U training and/or serve as a classroom-based (e.g., assistant, behavioral specialist) or administrative (e.g., center director) staff for the classrooms participating in TCIT-U.
  • Speak and read English proficiently.
  • Provide written informed consent.

Educational Staff's Exclusion Criteria (qualitative interviews): Do not speak and read English proficiently.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TCIT-U
Four teachers from two Head Start classrooms will be assigned to Teacher-Child Interaction Training - Universal (TCIT-U). TCIT-U occurs in two phases (6 weeks per phase): Child-Directed Interaction (CDI; focusing on relationship building) and Teacher-Directed Interaction (TDI; focusing on managing behavior problems). The TCIT-U Trainer (a licensed clinical child psychologist) will provide teachers with group didactic sessions (6 hours per phase) and individualized live coaching in their classrooms (20 minutes, once per week). Strategies include the use of PRIDE skills (Praise, Reflection, Imitation, Behavior Description, and Enthusiasm) or specific verbalizations that promote warm, responsive interactions, as well as classroom-appropriate behavior modification strategies which include using effective commands, prompts, natural consequences, differential social attention, and a modified time-out appropriate for use in a classroom.
Behavioral: Teacher-Child Interaction Training - Universal
Teacher-Child Interaction Training - Universal (TCIT-U) is an empirically-supported classroom-based intervention designed to strengthen teacher-child relationships, reduce and prevent child behavior problems, and promote social-emotional skills. TCIT-U is based in behavioral and attachment principles and was developed as a modification of Parent-Child Interaction Therapy (PCIT), an evidence-based treatment with well-established support for decreasing disruptive child behaviors and parental stress with children ages two to seven years old. In TCIT-U, teachers of children, preschool through second grade, are taught and coached in skills to manage challenging classroom behaviors and improve the quality of relationships. TCIT-U is delivered to teachers through group didactic training and live individualized coaching.
No Intervention: Usual Care
Four teachers from 2 PreK Counts classrooms will be assigned to the Usual Care (UC) group. They will continue their existing behavioral management strategies and techniques. Teachers will report on specific training in and use of other behavior management and social-emotional learning programs at baseline. At the conclusion of the study, UC teachers and staff will be offered didactic training in TCIT-U principles and strategies.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Teacher-Child Interaction Coding System (TCICS)
Time Frame: Week 1, Week 6-8, Week 12, and Month 10
Teachers' use and maintenance of skills taught in TCIT-U will be measured using the Teacher-Child Interaction Coding System (TCICS; Budd & Stern, 2019), an observational coding system that has been used in prior TCIT-U projects and was adapted from the coding system used in PCIT (Dyadic Parent-Child Interaction Coding System, 4th edition; Eyberg, Chase, Fernandez, & Nelson, 2014). RAs, blind to study condition, will tally teachers' verbalizations (Labeled Praises, Reflections, Descriptions, Questions, Commands, and Negative Talk) during 5-minute intervals which will be conducted three times at each data collection time-point (baseline, mid-intervention, post-intervention, and follow-up).
Week 1, Week 6-8, Week 12, and Month 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Teachers' Sense of Efficacy Scale (TSES)
Time Frame: Week 1, Week 12, and Month 10
Teachers' beliefs in their capability of influencing factors related to academic instruction and student behavior will be assessed using the Teachers' Sense of Efficacy Scale (TSES; Tschannen-Moran & Woolfolk Hoy, 2001). Teachers will rate their perceived efficacy in three areas (Student Engagement, Instructional Practices, and Classroom Management) at baseline, post-intervention, and follow-up. The rating is based on a scale of 1 (nothing), to 9 (a great deal).
Week 1, Week 12, and Month 10
Devereux Early Childhood Assessment for Preschoolers, 2nd Edition (DECA-P2)
Time Frame: Week 1, Week 12, and Month 10
Child behavior problems (e.g., noncompliance, aggression) and social-emotional skills (e.g., self-regulation) will be assessed using the Devereux Early Childhood Assessment for Preschoolers, Second Edition (DECA-P2; LeBuffe & Naglieri, 2012). The DECA-P2 is a 38-item standardized, strengths-based behavior rating scale that yields a Total Protective Factors scale (Initiative, Self-Regulation, Attachment/Relationships) and a Behavioral Concerns scale. Teachers will rate the frequency of children's behavior at baseline, post-intervention, and follow-up.
Week 1, Week 12, and Month 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Philadelphia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PNC Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rebecca M Kanine, PhD, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-016084
  • IRB 19-016084 (Other Identifier: Children's Hospital of Philadelphia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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