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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03693209
Other study ID # 017275
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2018
Est. completion date June 28, 2019

Study information

Verified date November 2020
Source University of Sheffield
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will test whether making plans of action for situations that trigger anger is effective in reducing anger and aggression in adolescents with behavioural problems. Participants will be assigned to three groups: a control group and two experimental groups. Participants assigned to the experimental groups will receive either one general anger trigger or a list of specific anger triggers in addition to a list of strategies that can be used to manage anger. Participants will be instructed to link the triggers with the strategies, thus creating action plans with an if-then structure. Participants assigned to the control group will receive the same lists. However, they will receive different instructions which will ask them to select separately the most encountered triggers and the most useful strategies. It is expected that making plans will reduce the anger and aggression of participants. It is also expected that the reduction will be larger for participants with low violent intentions, low callous-unemotional traits and low impulsivity.


Description:

This study aims to test whether aggression in adolescents can be reduced using implementation intentions. This technique involves identifying critical situations that might trigger the unwanted behaviour and making a plan to engage in an alternative course of action when those triggers are present. Implementation intentions formation has been found to be effective in reducing smoking uptake and consultations for emergency contraception in this age group. A randomised controlled trial will be conducted. Students from 11 to 17 years old attending special schools for children with behavioural problems or referred for anger issues will be randomised to three conditions: attention control, specific triggers and general trigger. Participants in the attention control and specific triggers conditions will receive the same Volitional Help Sheet (VHS), composed of a list of 10 anger triggers (if statements) and a list of 10 anger management strategies (then statements). However, the instructions will be different. Participants in the attention control condition will be instructed to select the triggers that they encounter more often and the strategies that they consider more useful. In contrast, participants in the specific triggers condition will have to link each specific trigger that they encounter often with a specific strategy, thus creating action plans with an if-then structure. Participants assigned to the general trigger condition will also be instructed to make plans linking the trigger with a strategy, but the VHS they will receive will contain only one general trigger: "If I am getting angry". Measures of anger and reactive physical aggression, reactive relational aggression, proactive physical aggression and proactive relation aggression will be collected at baseline, one month and six months after intervention. In addition, measures of negative urgency, violent intentions and callous-unemotional traits will be collected once. Both intervention groups are hypothesised to reduce anger and reactive aggression in comparison to the control group. It is hypothesised that the reduction in anger acts as a mediator for the reduction of reactive aggression. It is also hypothesised that violent intentions, callous-unemotional traits and negative urgency act as moderators of effectiveness. The effects of the intervention will be analysed on anger, on the aggression total score and on the four types of aggression separately using Multivariate Analysis of Covariance. In order to test whether the effect of the interventions on reactive aggression at follow-up is mediated by anger, a mediation analysis will be conducted using the PROCESS macro (Hayes, 2013). In the analysis, the intervention conditions (dummy coded) will be entered as the independent variable, anger as the mediator variable, reactive aggression at follow-up as the dependent variable, and reactive aggression at baseline as the covariate. The analysis will asses the strength of the direct and indirect effects of the interventions on reactive aggression via anger. In order to test whether the effect of the interventions on aggression at follow-up is moderated by violent intentions, callous-unemotional traits and negative urgency, a moderated regression analysis will be conducted using the PROCESS macro (Hayes, 2013). In the analysis, the intervention conditions (dummy coded) will be entered as the independent variable, violent intentions, callous-unemotional traits and negative urgency as the moderator variables, aggression at follow-up as the dependent variable, and aggression at baseline as covariates.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 28, 2019
Est. primary completion date June 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion Criteria: - Attending a school for children with Social, Emotional and Mental Health needs. - Being referred by school staff due to anger issues or behavioural problems. Exclusion Criteria: - Having severe or profound learning disabilities.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Volitional Help Sheet (VHS)
VHS with a general anger trigger and 10 anger management strategies
Volitional Help Sheet (VHS)
VHS with 10 specific anger triggers and 10 anger management strategies

Locations

Country Name City State
United Kingdom Schools for children with Social Emotional and Mental Health needs. Leeds
United Kingdom Schools for children with Social Emotional and Mental Health needs. Sheffield
United Kingdom Secondary schools Sheffield

Sponsors (2)

Lead Sponsor Collaborator
University of Sheffield University of Manchester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Marsee MA., Kimonis ER., Frick PJ. Peer conflict scale. Unpublished rating scale, University of New Orleans, 2004.

Novaco RW. Dimensions of Anger Reactions. Irvine, CA: University of California; 1975.

Scott BG, Lapré GE, Marsee MA, Weems CF. Aggressive behavior and its associations with posttraumatic stress and academic achievement following a natural disaster. J Clin Child Adolesc Psychol. 2014;43(1):43-50. doi: 10.1080/15374416.2013.807733. Epub 2013 Jun 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Peer Conflict Scale - Youth self-report (Scott, Lapré, Marsee, & Weems, 2014) Self-report measure of aggression with 20 items. Each item can be rated from 0 (not at all true) to 3 (definitely true). Total scores range from 0 to 60. Higher scores indicate higher aggression. It contains four sub-scales: reactive physical aggression, reactive relational aggression, proactive physical aggression and proactive relational aggression. Each subscale contains 5 items and the score for each range from 0 to 15. Change from baseline to 6 months after intervention
Secondary Dimensions of Anger Reactions Scale (DAR-5; Novaco, 1975) Self-report measure of anger with 5 items. Each item can be rated from 1 (none or almost none of the time) to 5 (all or almost all of the time). Total scores range from 5 to 25. Higher scores indicate higher anger symptoms. Measured at baseline, one month after intervention and 6 months after intervention
Secondary Peer Conflict Scale - Teacher report (Marsee, Kimonis, & Frick, 2004) Teacher report measure of aggression with 40 items. Each item can be rated from 0 (not at all true) to 3 (definitely true). Total scores range from 0 to 120. Higher scores indicate higher aggression. It contains four sub-scales: reactive physical aggression, reactive relational aggression, proactive physical aggression and proactive relational aggression. Each subscale contains 10 items and the score for each range from 0 to 30. Measured at baseline, one month after intervention and 6 months after intervention
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