Effectiveness of an Anti-bullying Intervention for Adolescent Perpetrators

January 28, 2016 updated by: Booog Nyung Kim, Seoul National University Childrens Hospital

Effectiveness of an Anti-bullying Intervention for Adolescent Perpetrators: Using Tools Measuring Brain Function and Structure, Cognition and Behavior.

The investigators recruited school bullying perpetrators from the age of 12 to 17 by referral from the local police department. An anti-bullying intervention based on cognitive-behavioral therapy (CBT) principles was conducted, and addressed issues related to impulse control, empathy and communication enhancement. All participants completed brain magnetic resonance imaging, neurocognitive tests, and questionnaires before and after the intervention.

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

The present study included previous perpetrators of school bullying who were convicted for a minor offense, including physical or verbal assaults or theft, and who were referred by the police to participate in an anti-bullying intervention. The program consisted of 8 sessions over 4 weeks and was conducted by a board-certified psychiatrist and a therapist with previous training in psychosocial treatments. The intervention was based on CBT principles and addressed various factors that have been associated with perpetrators of school bullying, including impulse control, perspective taking (empathy), and the enhancement of communication skills.

All participants completed the Korean Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) administered by board-certified child and adolescent psychiatrists. The validity and reliability of the original and Korean versions of the K-SADS-PL have been established. Intelligence quotient (IQ) was measured using the Korean Educational Developmental Institute's Wechsler Intelligence Scale for Children.

Prior to and after participation in the program, all participants underwent brain magnetic resonance imaging (structural and functional) and completed neurocognitive tests that included the continuous performance test (CPT), the Stroop Word and Color Test, and the Wisconsin Card Sorting Test (WCST). The parents of the participants completed questionnaires including the Child Behavior Checklist (CBCL). Written informed consent was obtained from the parents and the participants after sufficient explanation of the study. The study protocol was approved by the institutional review board of the Seoul National University Hospital.

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.
27

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

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No psychiatric diagnosis or psychiatric diagnoses including conduct disorder, depressive disorder, oppositional defiant disorder, attention-deficit hyperactivity disorder, and adjustment disorder.
  • IQ > 70
  • Agreement to participate
  • Ability to cooperate in group therapy

Exclusion Criteria:

  • Any psychotic disorder
  • Severe impairment in impulse control
  • Not cooperating with program participation
  • IQ < 70
  • Current or past history of brain trauma or organic brain disorder, seizure disorder, or any neurological disorder.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group 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: Anti-bullying intervention
An anti-bullying intervention target to perpetrators of school bullying was conducted. The program consisted of 8 sessions over 4 weeks and was conducted by a board-certified psychiatrist and a therapist with previous training in psychosocial treatments. The intervention was based on cognitive-behavioral therapy (CBT) principles and addressed various factors that have been associated with perpetrators of school bullying, including impulse control, perspective taking (empathy), and the enhancement of communication skills.
Behavioral: Anti-bullying intervention

The title of each session were as follows :

  1. Introduction of intervention and setting rules, building rapport
  2. Understanding school bullying (The definition of school bullying and proper coping strategies)
  3. Empathy of others ( Practice of understanding victims of school bullying)
  4. Impulse control 1 (Understanding my anger patterns, finding one's true feelings behind that anger)
  5. Impulse control 2 (Finding irrational thoughts that lead to anger and correction of them)
  6. Conflict management (Understanding one's pattern of dealing with conflicts, finding effective strategies)
  7. Communication skills enhancement
  8. Increasing self esteem

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
Time Frame
Brain activity measured by functional magnetic resonance imaging (fMRI)
Time Frame: 1 month
1 month

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
Time Frame
Aggression measured by the Child Behavior Checklist based on parent-report
Time Frame: 1 month
1 month
Cognitive flexibility measured by the Wisconsin Card Sorting Test
Time Frame: 1 month
1 month

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.
Seoul National University Childrens Hospital

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.

General Publications

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.
January 1, 2014

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 1, 2015

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.
June 1, 2015

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).
January 27, 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.
January 28, 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.
February 2, 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.
February 2, 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.
January 28, 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.
January 1, 2016

More Information

Terms related to this study

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.
  • 0720152106

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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