AggressionNCT03693209
Using Implementation Intentions to Reduce Anger and Aggression in Adolescence
A study testing Volitional Help Sheet (VHS) in people with Aggression and Anger, run by University of Sheffield at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggression, Anger
- What is being tested?
- Volitional Help Sheet (VHS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 16 Oct 2018to 28 Jun 2019
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attending a school for children with Social, Emotional and Mental Health needs.
- Being referred by school staff due to anger issues or behavioural problems.
Who cannot join
- Having severe or profound learning disabilities.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Schools for children with Social Emotional and Mental Health needs.
Leeds
Schools for children with Social Emotional and Mental Health needs.
Sheffield
Secondary schools
Sheffield
About this study
Official title: 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.
Read the 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.
- Conditions
- Aggression, Anger
- Being tested
- Volitional Help Sheet (VHS)
- Keywords
- Implementation intentions, Volitional Help Sheet, Adolescent
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volitional Help Sheet (VHS)Behavioural
Also called implementation intentions, action-planning
VHS with a general anger trigger and 10 anger management strategies
Volitional Help Sheet (VHS)Behavioural
Also called implementation intentions, action-planning
VHS with 10 specific anger triggers and 10 anger management strategies
| Study group | Role | What they receive |
|---|---|---|
| General trigger | Experimental | 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. Receives: Behavioral: Volitional Help Sheet (VHS) |
| Specific triggers | Experimental | 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. Receives: Behavioral: Volitional Help Sheet (VHS) |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 6 months after intervention
Secondary outcomes (2)
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: Measured at baseline, one month after intervention and 6 months after intervention
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: Measured at baseline, one month after intervention and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start16 Oct 2018
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AggressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be one control group and two intervention groups. Each group will be independently be compared with the others, and not in combination.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Principal investigator, Laura Castillo Eito, University of Sheffield
- Investigators
- Laura Castillo-Eito, Msc, Principal investigator, University of SheffieldChristopher J Armitage, PhD, Study director, University of ManchesterPaul Norman, PhD, Study director, University of SheffieldRichard Rowe, PhD, Study director, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693209
- Sponsor's protocol ID
- 017275
- Status last verified
- Nov 2020
- First submitted
- 24 Sep 2018
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23795776Marsee 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 at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Brief Intervention Based on Implementation Intentions to Reduce Anger and Aggression in Adolescence: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03693209
- Acronym / sponsor ID
- 017275
- Conditions
- Aggression, Anger
- Keywords
- Implementation intentions, Volitional Help Sheet, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 2 Oct 2018 (actual)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- There will be one control group and two intervention groups. Each group will be independently be compared with the others, and not in combination.
| Arm | Type | Receives |
|---|---|---|
| General trigger | Experimental | Behavioral: Volitional Help Sheet (VHS)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. |
| Specific triggers | Experimental | Behavioral: Volitional Help Sheet (VHS)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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Attending a school for children with Social, Emotional and Mental Health needs.
- Being referred by school staff due to anger issues or behavioural problems.
Key exclusion criteria (1 listed)
- Having severe or profound learning disabilities.
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 |
|---|---|---|
| Volitional Help Sheet (VHS)Also: implementation intentions, action-planningVHS with a general anger trigger and 10 anger management strategies | Behavioural | General trigger |
| Volitional Help Sheet (VHS)Also: implementation intentions, action-planningVHS with 10 specific anger triggers and 10 anger management strategies | Behavioural | Specific triggers |
Primary outcome
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.
2 secondary outcomes
Dimensions of Anger Reactions Scale (DAR-5; Novaco, 1975)
Time frame: 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
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 19 Nov 2020.
- Background: PubMed 23795776Scott 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.
- BackgroundMarsee MA., Kimonis ER., Frick PJ. Peer conflict scale. Unpublished rating scale, University of New Orleans, 2004.
- BackgroundNovaco RW. Dimensions of Anger Reactions. Irvine, CA: University of California; 1975.
- Individual participant dataSharing planned: Undecided
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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.
Laura Castillo-Eito, Msc principal investigator
University of Sheffield
Christopher J Armitage, PhD study director
University of Manchester
Paul Norman, PhD study director
University of Sheffield
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volitional Help Sheet (VHS) in people with Aggression and Anger, run by University of Sheffield at 3 sites in United Kingdom.
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 2 inclusion and 1 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Brief Peer Conflict Scale - Youth self-report (Scott, Lapré, Marsee, & Weems, 2014) (time frame: Change from baseline to 6 months after intervention). 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 NCT03693209, which also lists 3 linked publications.
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 19 Nov 2020.