AggressionNCT04130360
A Trial of an Online Problem-solving Intervention for Aggression
A study testing Problem-solving in people with Aggression, run by University of Sheffield at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Aggression
- What is being tested?
- Problem-solving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 908 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2019to 30 Mar 2020
- 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 18 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Living in the UK
- Fluent in English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Sheffield
Sheffield, South Yorkshire, S1 2LT
About this study
Official title: 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.
Read more
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.
- Conditions
- Aggression
- Being tested
- Problem-solving
- Keywords
- problem-solving, youth, brief intervention, online intervention, young people, aggressive behaviour
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-solvingBehavioural
Also called social 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.
| Study group | Role | What they receive |
|---|---|---|
| Problem-solving | Experimental | Not described Receives: Behavioral: Problem-solving |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start25 Oct 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control group. Participants are randomised to one of them.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 908 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Laura Castillo-Eito, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130360
- Sponsor's protocol ID
- 030755
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data will be shared, but there is not a concrete plan at the moment.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Online Problem-solving Intervention to Reduce Aggression Among Youth
- ClinicalTrials.gov ID
- NCT04130360
- Acronym / sponsor ID
- 030755
- Conditions
- Aggression
- Keywords
- problem-solving, youth, brief intervention, online intervention, young people, aggressive behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 908 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 17 Oct 2019 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention and control group. Participants are randomised to one of them.
| Arm | Type | Receives |
|---|---|---|
| Problem-solving | Experimental | Behavioral: Problem-solving |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Living in the UK
- Fluent in English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Problem-solvingAlso: social problem-solvingThe 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. | Behavioural | Problem-solving |
Primary outcome
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.
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.
2 secondary outcomes
Problem-solving skills
Time frame: 1 month
Problem-solving self-efficacy
Time frame: 1 month
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 20 Nov 2020.
- Individual participant dataSharing planned: Undecided. Anonymised data will be shared, but there is not a concrete plan at the moment.
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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 principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-solving in people with Aggression, run by University of Sheffield at 1 site 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 0 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 20 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 1 site 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?
Aggression (trait) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2020.