Conduct DisorderNCT02670876
Effectiveness of an Anti-bullying Intervention for Adolescent Perpetrators
A study testing Anti-bullying intervention in people with Conduct Disorder, run by Seoul National University Childrens Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Conduct Disorder
- What is being tested?
- Anti-bullying intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2015
- 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Conduct Disorder
- Being tested
- Anti-bullying intervention
- Medical subject headings
- Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-bullying interventionBehavioural
The title of each session were as follows :
- Introduction of intervention and setting rules, building rapport
- Understanding school bullying (The definition of school bullying and proper coping strategies)
- Empathy of others ( Practice of understanding victims of school bullying)
- Impulse control 1 (Understanding my anger patterns, finding one's true feelings behind that anger)
- Impulse control 2 (Finding irrational thoughts that lead to anger and correction of them)
- Conflict management (Understanding one's pattern of dealing with conflicts, finding effective strategies)
- Communication skills enhancement
- Increasing self esteem
| Study group | Role | What they receive |
|---|---|---|
| Anti-bullying intervention | Experimental | 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. Receives: Behavioral: Anti-bullying intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity measured by functional magnetic resonance imaging (fMRI)
Measured: 1 month
Secondary outcomes (2)
Aggression measured by the Child Behavior Checklist based on parent-report
Measured: 1 month
Cognitive flexibility measured by the Wisconsin Card Sorting Test
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conduct DisorderStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Childrens Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Booog Nyung Kim, Seoul National University Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670876
- Sponsor's protocol ID
- 0720152106
- Status last verified
- Jan 2016
- First submitted
- 27 Jan 2016
- Last updated
- 2 Feb 2016
- Results posted
- No
Publications
Kim JI, Kang YH, Lee JM, Cha J, Park YH, Kweon KJ, Kim BN. Resting-state functional magnetic resonance imaging investigation of the neural correlates of cognitive-behavioral therapy for externalizing behavior problems in adolescent bullies. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Aug 30;86:193-202. doi: 10.1016/j.pnpbp.2018.05.024. Epub 2018 Jun 6.
PubMed 29885469
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Anti-bullying Intervention for Adolescent Perpetrators: Using Tools Measuring Brain Function and Structure, Cognition and Behavior.
- ClinicalTrials.gov ID
- NCT02670876
- Acronym / sponsor ID
- 0720152106
- Conditions
- Conduct Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Seoul National University Childrens HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-bullying intervention | Experimental | Behavioral: Anti-bullying interventionAn 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Anti-bullying interventionThe 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 | Behavioural | Anti-bullying intervention |
Primary outcome
Brain activity measured by functional magnetic resonance imaging (fMRI)
Time frame: 1 month
2 secondary outcomes
Aggression measured by the Child Behavior Checklist based on parent-report
Time frame: 1 month
Cognitive flexibility measured by the Wisconsin Card Sorting Test
Time frame: 1 month
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 2 Feb 2016.
- Derived from this study: PubMed 29885469Kim JI, Kang YH, Lee JM, Cha J, Park YH, Kweon KJ, Kim BN. Resting-state functional magnetic resonance imaging investigation of the neural correlates of cognitive-behavioral therapy for externalizing behavior problems in adolescent bullies. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Aug 30;86:193-202. doi: 10.1016/j.pnpbp.2018.05.024. Epub 2018 Jun 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-bullying intervention in people with Conduct Disorder, run by Seoul National University Childrens Hospital.
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 4 inclusion and 5 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Brain activity measured by functional magnetic resonance imaging (fMRI) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02670876, which also lists 1 linked publication.
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 2 Feb 2016.