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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00431470
Other study ID # 06/09/VA01
Secondary ID
Status Completed
Phase N/A
First received February 2, 2007
Last updated February 4, 2009
Start date February 2007
Est. completion date May 2007

Study information

Verified date October 2006
Source Maimonides Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Through the use of an educational intervention, the object of this study is to reduce the prevalence of bullying behaviors among fifth grade school age children. Bullying behaviors promote an environment of violence , fear, and hostility. The study will arrange to present six character education lessons in the classroom of fifth grade students in a New York City public school. Questionnaires will be administered to the students before and after all the lessons have been completed. Questionnaires will collect information about the students self perception of their levels of misconduct, impulsivity, confidence, value of non violence, ways of handling anger, opinions of their leadership behaviors, prevalence of bullying behaviors, and indications of levels of self esteem. Also, their fifth grade teachers will complete pre and post treatment student behavioral questionnaires.


Description:

This is a 2 X 2X 2 research design that will study the constructs of self esteem, leadership skills, and prevalence of bullying among a fifth grade school age population. Before data collection, a letter describing the study along with an informed consent sheet, will be mailed to the student's parent/guardian. The written material will state that their child participation is not mandatory. A 48 item likert style questionnaire pre-treatment, post-treatment survey design will be administered to students. Basic demographic questions will also be asked about.

All fifth graders will be given questionnaires before they receive the six classroom lessons of 45 minutes duration and then after all the six lessons have been completed. Lessons will be offered on a weekly basis. The fifth graders will be divided into small groups of approximately 10 individuals. The lessons will be delivered by baccalaureate nursing students in their last semester of college. The groups will be formed at the beginning and membership will remain consistent to enhance development of trust and ease of authentic communication. The lessons will be selected from the program, Overcoming Obstacles, a formal educational program designed to assist students to communicate well and set meaningful goals for their lives. In addition, the classroom teachers will be asked to complete a 14 item likert style pre-treatment, post-treatment, both before and after the six lessons about their opinions of each student's behaviors pattern.

A statistician is a co-investigator and will identify the type of statistical analysis to be done.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Years to 13 Years
Eligibility Inclusion Criteria:

- Fifth grade elementary school students

Exclusion Criteria:

- Special education students

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Six classroom based character building education lessons


Locations

Country Name City State
United States PS 45 Staten Island New York

Sponsors (1)

Lead Sponsor Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaires Complete No
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