- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130360
A Trial of an Online Problem-solving Intervention for Aggression
A Randomized Controlled Trial of an Online Problem-solving Intervention to Reduce Aggression Among Youth
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Yorkshire
-
Sheffield, South Yorkshire, United Kingdom, S1 2LT
- University of Sheffield
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Living in the UK
- Fluent in English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Problem-solving
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aggression (trait)
Time Frame: 1 month
|
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.
|
1 month
|
|
Aggression (frequency)
Time Frame: 1 month
|
Physical and relational aggression questionnaire.
Each item is responded from 1 (never) to 5 (5 or more times), with higher scores meaning higher aggression.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Problem-solving skills
Time Frame: 1 month
|
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.
|
1 month
|
|
Problem-solving self-efficacy
Time Frame: 1 month
|
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.
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura Castillo-Eito, University of Sheffield
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 030755
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Aggression
-
Boston UniversityU.S. Department of JusticeCompletedSexual Aggression | Offensive Aggression | Dating Violence Perpetration and VictimizationUnited States
-
University of KonstanzCompletedAppetitive AggressionGermany
-
New York State Psychiatric InstituteCompletedIrritable AggressionUnited States
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Arizona State UniversityCompletedHeavy Drinking | Sexual AggressionUnited States
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Supernus Pharmaceuticals, Inc.CompletedImpulsive AggressionUnited States
-
Weill Medical College of Cornell UniversityGreen Chimneys Residential Treatment Center, Brewster, NYCompletedChildhood AggressionUnited States
-
Supernus Pharmaceuticals, Inc.CompletedImpulsive Aggression Comorbid With ADHDUnited Kingdom
-
Arizona State UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Georgia State UniversityCompletedAlcohol Drinking | Sexual Behavior | Emotions | Sexual AggressionUnited States
-
Children's Hospital of PhiladelphiaThe School District of PhiladelphiaRecruitingSocial Behavior | Aggression Childhood | Bullying VictimizationUnited States
Clinical Trials on Problem-solving
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedDepressionUnited States
-
Istanbul UniversityCompleted
-
University of OttawaOttawa Hospital Research InstituteActive, not recruiting
-
Washington University School of MedicineNurses for Newborns FoundationCompletedPost-partum DepressionUnited States
-
VA Office of Research and DevelopmentCompletedDepression | AnxietyUnited States
-
University of PittsburghNational Institute of Mental Health (NIMH)CompletedMild Cognitive ImpairmentUnited States
-
VA Office of Research and DevelopmentCompleted
-
Children's Hospital Medical Center, CincinnatiPatient-Centered Outcomes Research Institute; Children's Hospital Colorado; Nationwide... and other collaboratorsCompletedWounds and Injuries | Brain Injuries | Craniocerebral Trauma | Trauma, Nervous System | Brain Concussion | Head Injuries, Closed | Head Injury | Brain Edema | Disorders of Environmental Origin | Brain Hemorrhage, Traumatic | Subdural Hematoma | Epidural Hematoma | Intracranial Edema | Tbi | Cortical ContusionUnited States
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical CenterCompletedMajor Depressive DisorderUnited States
-
Boston Medical CenterHRSA/Maternal and Child Health BureauCompletedMaternal DepressionUnited States