- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693209
Using Implementation Intentions to Reduce Anger and Aggression in Adolescence
Evaluation of a Brief Intervention Based on Implementation Intentions to Reduce Anger and Aggression in Adolescence: A Randomised Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Leeds, United Kingdom
- Schools for children with Social Emotional and Mental Health needs.
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Sheffield, United Kingdom
- Schools for children with Social Emotional and Mental Health needs.
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Sheffield, United Kingdom
- Secondary Schools
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: General trigger
VHS with one general trigger: "If I am getting angry..." and 10 strategies (e.g.
"Then I will take deep breaths").
Participants are instructed to link trigger with strategies.
|
VHS with a general anger trigger and 10 anger management strategies
Other Names:
VHS with 10 specific anger triggers and 10 anger management strategies
Other Names:
|
Experimental: Specific triggers
VHS with a list of 10 specific situations that can act as anger triggers (e.g.
"If I am getting angry when people act like they know it all") and 10 strategies.
Participants are instructed to link triggers with strategies.
|
VHS with a general anger trigger and 10 anger management strategies
Other Names:
VHS with 10 specific anger triggers and 10 anger management strategies
Other Names:
|
No Intervention: Control
List of 10 specific situations that can act as anger triggers and 10 strategies.
Participants are instructed to select most encountered triggers and most useful strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Peer Conflict Scale - Youth self-report (Scott, Lapré, Marsee, & Weems, 2014)
Time Frame: Change from baseline to 6 months after intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dimensions of Anger Reactions Scale (DAR-5; Novaco, 1975)
Time Frame: Measured at baseline, one month after intervention and 6 months after intervention
|
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
|
Peer Conflict Scale - Teacher report (Marsee, Kimonis, & Frick, 2004)
Time Frame: Measured at baseline, one month after intervention and 6 months after intervention
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura Castillo-Eito, Msc, University of Sheffield
- Study Director: Christopher J Armitage, PhD, University of Manchester
- Study Director: Paul Norman, PhD, University of Sheffield
- Study Director: Richard Rowe, PhD, University of Sheffield
Publications and helpful links
General Publications
- Scott BG, Lapre 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 017275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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