A Trial of an Online Problem-solving Intervention for Aggression
Primary Purpose
Aggression
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Problem-solving
Sponsored by
About this trial
This is an interventional basic science trial for Aggression focused on measuring problem-solving, youth, brief intervention, online intervention, young people, aggressive behaviour
Eligibility Criteria
Inclusion Criteria:
- Living in the UK
- Fluent in English
Sites / Locations
- University of Sheffield
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Problem-solving
Control
Arm Description
Outcomes
Primary Outcome Measures
Aggression (trait)
Aggression Questionnaire (AQ): Physical Aggression, Verbal Aggression, Hostility, Anger. Each item is responded from 1 (extrememly uncharacteristic of me) to 5 (extremely characteristic of me), with higher scores meaning higher aggression.
Aggression (frequency)
Physical and relational aggression questionnaire. Each item is responded from 1 (never) to 5 (5 or more times), with higher scores meaning higher aggression.
Secondary Outcome Measures
Problem-solving skills
Problem Solving Skills (PSI-PSS). Each item is responded from 1 (strongly disagree) to 6 (strongly agree), with higher scores meaning higher problem-solving skills.
Problem-solving self-efficacy
Problem Solving Self-Efficacy (PSI-PSSE). Each item is responded from 1 (strongly disagree) to 6 (strongly agree), with higher scores meaning higher problem-solving self-efficacy.
Full Information
NCT ID
NCT04130360
First Posted
October 16, 2019
Last Updated
November 19, 2020
Sponsor
University of Sheffield
Collaborators
University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT04130360
Brief Title
A Trial of an Online Problem-solving Intervention for Aggression
Official Title
A Randomized Controlled Trial of an Online Problem-solving Intervention to Reduce Aggression Among Youth
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sheffield
Collaborators
University of Manchester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aggressive behaviour among adolescents is a social problem that can be reduced by social problem-solving interventions. However, these interventions usually include more than one technique, and the specific techniques that are effective in reducing and preventing aggression remain to be identified. Therefore, the main aim of this study is to test whether the instruction and practice of problem-solving on their own are effective in changing aggressive behaviour among adolescents.
As the intervention in this trial is aimed at the general population, it will be delivered online. The rapid growth in the use of the Internet among young people provides an opportunity to deliver interventions universally in a cheap and efficient way.
Problem-solving skills are fundamental to effective behaviour change. Therefore, problem-solving skills will be measured to assess whether they mediate the effect of the intervention on aggressive behaviour.
Finally, young people with callous-unemotional traits are less likely to change their problematic behaviour such as aggression after an intervention. Therefore, Callous-Unemotional traits will be measured to assess if they act as a moderator of effectiveness.
It is expected that participants randomised to the intervention improve their problem-solving skills and consequentially, reduce their aggressive behaviours. In addition, participants with lower callous-unemotional traits are expected to have a greater change.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggression
Keywords
problem-solving, youth, brief intervention, online intervention, young people, aggressive behaviour
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention and control group. Participants are randomised to one of them.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants are not told that they are being randomised or that they are participating in an intervention trial until they complete the follow-up. Randomisation is computerized and participants have no contact with a care provider or an investigator.
Allocation
Randomized
Enrollment
908 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Problem-solving
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Problem-solving
Other Intervention Name(s)
social problem-solving
Intervention Description
The steps of problem-solving are explained to the participants. Then, they are presented two conflictive situations and they are asked to apply the problem-solving steps to find a solution. Once they finish, they are asked to apply the steps in a conflictive situation they have experience in the last month. In the end, they are reminded of the steps and encouraged to practice them in their daily conflicts.
Primary Outcome Measure Information:
Title
Aggression (trait)
Description
Aggression Questionnaire (AQ): Physical Aggression, Verbal Aggression, Hostility, Anger. Each item is responded from 1 (extrememly uncharacteristic of me) to 5 (extremely characteristic of me), with higher scores meaning higher aggression.
Time Frame
1 month
Title
Aggression (frequency)
Description
Physical and relational aggression questionnaire. Each item is responded from 1 (never) to 5 (5 or more times), with higher scores meaning higher aggression.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Problem-solving skills
Description
Problem Solving Skills (PSI-PSS). Each item is responded from 1 (strongly disagree) to 6 (strongly agree), with higher scores meaning higher problem-solving skills.
Time Frame
1 month
Title
Problem-solving self-efficacy
Description
Problem Solving Self-Efficacy (PSI-PSSE). Each item is responded from 1 (strongly disagree) to 6 (strongly agree), with higher scores meaning higher problem-solving self-efficacy.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Living in the UK
Fluent in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Castillo-Eito
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sheffield
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S1 2LT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Anonymised data will be shared, but there is not a concrete plan at the moment.
Learn more about this trial
A Trial of an Online Problem-solving Intervention for Aggression
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