NCT03693209

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

October 16, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

September 24, 2018

Last Update Submit

November 17, 2020

Conditions

Keywords

Implementation intentionsVolitional Help SheetAdolescent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Dimensions of Anger Reactions Scale (DAR-5; Novaco, 1975)

    Measured at baseline, one month after intervention and 6 months after intervention

  • Peer Conflict Scale - Teacher report (Marsee, Kimonis, & Frick, 2004)

    Measured at baseline, one month after intervention and 6 months after intervention

Study Arms (3)

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.

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.

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.

Interventions

VHS with a general anger trigger and 10 anger management strategies

Also known as: implementation intentions, action-planning
General trigger

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Attending a school for children with Social, Emotional and Mental Health needs.
  • Being referred by school staff due to anger issues or behavioural problems.

You may not qualify if:

  • Having severe or profound learning disabilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Schools for children with Social Emotional and Mental Health needs.

Leeds, United Kingdom

Location

Schools for children with Social Emotional and Mental Health needs.

Sheffield, United Kingdom

Location

Secondary schools

Sheffield, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 23795776BACKGROUND
  • Marsee MA., Kimonis ER., Frick PJ. Peer conflict scale. Unpublished rating scale, University of New Orleans, 2004.

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

    BACKGROUND

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Laura Castillo-Eito, Msc

    University of Sheffield

    PRINCIPAL INVESTIGATOR
  • Christopher J Armitage, PhD

    University of Manchester

    STUDY DIRECTOR
  • Paul Norman, PhD

    University of Sheffield

    STUDY DIRECTOR
  • Richard Rowe, PhD

    University of Sheffield

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The control condition is active and has a similar format to the intervention conditions to avoid participants knowing which condition they have been assigned to. Outcomes are assessed by self-report.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There will be one control group and two intervention groups. Each group will be independently be compared with the others, and not in combination.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2018

First Posted

October 2, 2018

Study Start

October 16, 2018

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

November 19, 2020

Record last verified: 2020-11

Locations