Evaluation of the IY TCM Program in Norwegian School and Day-care Settings (IYTCMNOR)

November 9, 2016 updated by: University of Tromso

Evaluation of the Incredible Years Teacher Classroom Management Program in Norwegian School and Day-care Settings: Changes in Students' (6-8 Year) and Children's Behavior (3-6 Year)

The purpose of this study is to evaluate whether training teacher and staff in the Incredible Years (IY) Teacher Classroom Management (TCM) program reduce behavior problems and promote social competence in student aged 6-8 years (school) and in children aged 3-6 year (day-care). To examine group differences from baseline to 8-9 months after, a quasi-experimental control group design with pre- and post-measurements was used.

Study Overview

Status

Status

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

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

Evaluation of the Incredible Years (IY) Teacher Classroom Management (TCM) program implemented as a school-wide preventive intervention in regular school and day-care settings, have the potential to change negative behaviors in children aged 3 - 8 year. Forty-four schools were recruited; comprising 1518 students aged 6-8 year, and 91 day-care units comprising 1049 children aged 3-6 year. Multilevel analyzes were used to examine group differences pre-post changes for behavior problems measured with the Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R) and the Teacher Report Form (TRF), as well as group differences pre-post change for social behavior measured the Social Skills Rating System (SSRS). For secondary findings, group differences pre-post changes for teacher- student and teacher-children relationship were measured with the Student-Teacher Relationship Scale (STRS) (teachers N= 444), and teacher-parents interactions were measured with the Teacher-Parent Involvement Questionnaire (INVOLVE-T/P) (parents N = 2109), as well as group differences pre-post change for teachers self- and collective efficacy measured the Norwegian Teacher Self-Efficacy Scale (NTSES) and the Collective Efficacy Scale (CES) (teachers N = 3240).

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.
5807

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

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 to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Schools who met predefined criteria for program implementation of IY TCM (intervention) and school who not have implemented any IY program (comparison).
  • Students/children aged 3-8 year (until 7 randomly selected from each class) with parents who speak Norwegian.
  • Teachers and staff who worked with students/children aged 3-8 years.

Exclusion Criteria:

  • Schools who did not met predefined criteria for program implementation of IY TCM.
  • Students/children aged 3-8 year with parents who did not speak Norwegian.
  • Teachers and staff who did not worked with students/children aged 3-8 years, and who have known the students/children for fewer than 3 weeks.

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: None (Open Label)

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: IY TCM
Incredible Year (IY) Teacher Classroom Management (TCM) training, 6 full-day workshops (42 hours)
Behavioral: IY TCM
The Incredible Years Teacher Classroom Management program is a manualized program for teachers and staff in school and day-care settings to strengthen teacher classroom management strategies, to reduce negative behavior and promote prosocial behavior, as well as school readiness in children. Two qualified IY TCM group-leaders (facilitators) train teachers and staff in groups through six full-day workshops (a total of 42 hours).Workshop 1: Building Positive Relationships with Students, Workshop 1b: Preventing Behavior Problems -The Proactive Teacher, Workshop 2: The Importance of Teacher Attention, Coaching and Praise, Workshop 3: Motivating Children Through Incentives, Workshop 4 & 5: Decreasing Inappropriate Behavior and Workshop 6: Emotional Regulation, Social Skills & Problem Solving.
No Intervention: Comparison
No Incredible Year (IY) Teacher Classroom Management (TCM) training.

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
Change in behavior for student 6-8 year measured with the Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R).
Time Frame: From baseline to 8-9 months after.
The Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R) is a 38-item scale where teacher rate the current frequency and severity of various behavior in student, and whether or not the behavior is currently a problem.
From baseline to 8-9 months after.
Change in behavior for student 6-8 year measured with the Teacher Report Form (TRF).
Time Frame: From baseline to 8-9 months after.
The Teacher Report Form (TRF) consist of 118 item and where teacher rate the degree of emotional and behavioral problems observed in students aged 6-18, and the student academic performance and adaptive function. The Total problem scale forms the basis for various subscales for syndromes or clusters of problems areas.
From baseline to 8-9 months after.
Change in behavior for student 6-8 year measured with the Social Skills Rating System (SSRS).
Time Frame: From baseline to 8-9 months after.
The Social Skills Rating System (SSRS) contains of 30 items and where teacher rate how often the student show specific social skills, as well as how important the teacher finds these skills for his/her work in classroom or for the student's success in classroom.
From baseline to 8-9 months after.
Change in behavior for student 6-8 year with severe behavior problems measured with the Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R).
Time Frame: From baseline to 8-9 months after.
The Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R) is a 38-item scale where teacher rate the current frequency and severity of various behavior in student, and whether or not the behavior is currently a problem.
From baseline to 8-9 months after.
Change in behavior for student 6-8 year with severe behavior problems measured with the Teacher Report Form (TRF).
Time Frame: From baseline to 8-9 months after.
The Teacher Report Form (TRF) consist of 118 item and where teacher rate the degree of emotional and behavioral problems observed in students aged 6-18, and the student academic performance and adaptive function. The Total problem scale forms the basis for various subscales for syndromes or clusters of problems areas.
From baseline to 8-9 months after.
Change in behavior for student 6-8 year with severe behavior problems measured with the Social Skills Rating System (SSRS).
Time Frame: From baseline to 8-9 months after.
The Social Skills Rating System (SSRS) contains of 30 items and where teacher rate how often the student show specific social skills, as well as how important the teacher finds these skills for his/her work in classroom or for the student's success in classroom.
From baseline to 8-9 months after.
Change in behavior for student 6-8 year with severe behavior problems measured with the Student-Teacher Relationship Scale (STRS).
Time Frame: From baseline to 8-9 months after.
The Student-Teacher Relationship Scale (STRS) consists of a 15-item scale and assess teacher perceptions of two features of their relationships with their students: closeness and conflict.
From baseline to 8-9 months after.
Change in behavior for children 3-6 year without and with severe behavior problems measured with the Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R).
Time Frame: From baseline to 8-9 months after.
The Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R) is a 38-item scale where teacher rate the current frequency and severity of various behavior in student, and whether or not the behavior is currently a problem.
From baseline to 8-9 months after.
Change in behavior for children 3-6 year without and with severe behavior problems measured the Caregiver-Teacher Report Form (CTRF)
Time Frame: From baseline to 8-9 months after.
The Caregiver-Teacher Report Form (CTRF) rated by teachers for children aged 1½-5, and obtain teachers ratings of 99 problem items plus descriptions of problems, disabilities, what concerns respondents most about the child, and the best things about the child.
From baseline to 8-9 months after.
Change in behavior for children 3-6 year without and with severe behavior problems measured the Social Competence and Behavior Evaluation Scale (SCBE) .
Time Frame: From baseline to 8-9 months after.
The Social Competence and Behavior Evaluation Scale (SCBE) is a 30-item questionnaire where teacher rate children behavioral problems (externalizing and internalizing) and social competence.
From baseline to 8-9 months after.

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
Change in teacher-student relationship for student 6-8 year measured with the Student-Teacher Relationship Scale (STRS).
Time Frame: From baseline to 8-9 months after.
The Student-Teacher Relationship Scale (STRS) consists of a 15-item scale and assess teacher perceptions of two features of their relationships with their students: closeness and conflict.
From baseline to 8-9 months after.
Change in teacher-parents interactions for student 6-8 year measured with the Teacher-Parent Involvement Questionnaire (INVOLVE-T).
Time Frame: From baseline to 8 - 9 months after.
Teacher-Parent Involvement Questionnaire (INVOLVE-T) consist of 20 items and addresses the degree of parental involvement in school based on teacher ratings.
From baseline to 8 - 9 months after.
Change in teacher self-efficacy measured with the Teacher Self-Efficacy Scale (student 6-8 year).
Time Frame: From baseline to 8 - 9 months after.
The Teacher Self-Efficacy Scale refers to the individual teacher ideas of their own ability to accomplish the tasks they are given as a teacher. It is a 24 item scale and consisting of six subscales. The six subscales are instruction, adapting education to individual student's needs, motivating students, keeping discipline, cooperating with colleagues and parents, and coping with changes and challenges.
From baseline to 8 - 9 months after.
Change in collective teacher efficacy measured with the Collective Teacher Efficacy Scale (student 6-8 year).
Time Frame: From baseline to 8 - 9 months after.
The Collective Teacher Efficacy Scale refers to the teacher beliefs about the collective capability of the organization to influence student achievement. Measures the perceived collective teacher efficacy (7 items), external control scale (5 items) and strain factors (4 items).
From baseline to 8 - 9 months after.
Change in teacher self-efficacy and collective teacher efficacy measured with Teacher Observed Problem Behavior in School Environment & Classroom (student 6-8 year).
Time Frame: From baseline to 8 - 9 months after.
The Teacher Observed Problem Behavior in School Environment & Classroom consists of a 23-item scale measuring teacher responses to problem behavior. This scale consists of five sub factors (positive and supportive responses, responses affected by problem solving and negotiation, moderate behavioral rectifying responses, negative consequences, and formal sanctions) giving two categories of classroom management styles; informal and formal.
From baseline to 8 - 9 months after.
Change in problem behavior for students 6-8 year measured with the Behavior in School Environment & Classroom (CES).
Time Frame: From baseline to 8 - 9 months after.
Behavior in School Environment & Classroom (CES) measures the prevalence of problem behaviour in classroom environment with 20 items, and school environment with 15 items.
From baseline to 8 - 9 months after.
Change in teacher self-efficacy and collective teacher efficacy measured with Classroom Climate Scale (student 6-8 year).
Time Frame: From baseline to 8 - 9 months after.
The Classroom Climate Scale (CCS) is a 14-item scale measuring the quality of the learning environment.
From baseline to 8 - 9 months after.
Change in student behavior; generalization effects to home environment for student 6-8 year measured with the Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R).
Time Frame: From baseline to 8 - 9 months after.
The Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R) is a 38-item scale where teacher rate the current frequency and severity of various behavior in student, and whether or not the behavior is currently a problem.
From baseline to 8 - 9 months after.
Change in student behavior; generalization effects to home environment for student 6-8 year measured with the Eyberg Child Behavior Inventory (ECBI).
Time Frame: From baseline to 8 - 9 months after.
Eyberg Child Behavior Inventory (ECBI) consist of 36 problem behaviors commonly reported by parents of children with conduct problems. The inventory assesses behavior on two dimensions, the frequency of the behavior, and whether or not, the behavior is currently a problem.
From baseline to 8 - 9 months after.
Change in teacher-children relationship for children 3-6 year measured with the Student-Teacher Relationship Scale (STRS).
Time Frame: From baseline to 8 - 9 months after.
The Student-Teacher Relationship Scale (STRS) consists of a 15-item scale and assess teacher perceptions of two features of their relationships with their students: closeness and conflict.
From baseline to 8 - 9 months after.
Change in teacher-parents interactions for children 3-6 year measured with the Teacher-Parent Involvement Questionnaire (INVOLVE-T).
Time Frame: From baseline to 8 - 9 months after.
Teacher-Parent Involvement Questionnaire (INVOLVE-T) consist of 20 items and addresses the degree of parental involvement in school based on teacher ratings.
From baseline to 8 - 9 months after.
Change in teacher self-efficacy measured with the Teacher Self-Efficacy Scale (student 3-6 year).
Time Frame: From baseline to 8 - 9 months after.
The Teacher Self-Efficacy Scale refers to the individual teacher ideas of their own ability to accomplish the tasks they are given as a teacher. It is a 24 item scale and consisting of six subscales. The six subscales are instruction, adapting education to individual student's needs, motivating students, keeping discipline, cooperating with colleagues and parents, and coping with changes and challenges.
From baseline to 8 - 9 months after.
Change in collective teacher efficacy measured with the Collective Teacher Efficacy Scale (student 3-6 year).
Time Frame: From baseline to 8 - 9 months after.
The Collective Teacher Efficacy Scale refers to the teacher beliefs about the collective capability of the organization to influence student achievement. Measures the perceived collective teacher efficacy (7 items), external control scale (5 items) and strain factors (4 items).
From baseline to 8 - 9 months after.
Change in teacher self-efficacy and collective teacher efficacy measured with The Teacher Observed Problem Behavior in School Environment & Classroom (student 3-6 year).
Time Frame: From baseline to 8 - 9 months after.
The Teacher Observed Problem Behavior in School Environment & Classroom consists of a 23-item scale measuring teacher responses to problem behavior. This scale consists of five sub factors (positive and supportive responses, responses affected by problem solving and negotiation, moderate behavioral rectifying responses, negative consequences, and formal sanctions) giving two categories of classroom management styles; informal and formal.
From baseline to 8 - 9 months after.
Change in children behavior; generalization effects to home environment for children 3-6 year measured with the Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R).
Time Frame: From baseline to 8 - 9 months after.
The Sutter-Eyberg Student Behavior Inventory-Revised (SESBI-R) is a 38-item scale where teacher rate the current frequency and severity of various behavior in student, and whether or not the behavior is currently a problem.
From baseline to 8 - 9 months after.
Change in children behavior; generalization effects to home environment for children 3-6 year measured with the Eyberg Child Behavior Inventory (ECBI).
Time Frame: From baseline to 8 - 9 months after.
Eyberg Child Behavior Inventory (ECBI) consist of 36 problem behaviors commonly reported by parents of children with conduct problems. The inventory assesses behavior on two dimensions, the frequency of the behavior, and whether or not, the behavior is currently a problem.
From baseline to 8 - 9 months after.

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.
University of Tromso

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.
Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

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.
August 1, 2009

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.
July 1, 2014

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.
August 1, 2014

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).
October 28, 2016

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.
November 9, 2016

First Posted (Estimate)

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.
November 11, 2016

Study Record Updates

Last Update Posted (Estimate)

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.
November 11, 2016

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.
November 9, 2016

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.
November 1, 2016

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.
  • UTromso 2009/655 (REK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data for the current study is protected by Norwegian law and cannot be made publicly available at the present moment. The UiT -Arctic University of Norway is in the process of making the metadata available for sharing through the Eutro program.

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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