NCT04130360

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
908

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

October 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

November 20, 2020

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

October 16, 2019

Last Update Submit

November 19, 2020

Conditions

Keywords

problem-solvingyouthbrief interventiononline interventionyoung peopleaggressive behaviour

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 month

Secondary Outcomes (2)

  • Problem-solving skills

    1 month

  • Problem-solving self-efficacy

    1 month

Study Arms (2)

Problem-solving

EXPERIMENTAL
Behavioral: Problem-solving

Control

NO INTERVENTION

Interventions

Problem-solvingBEHAVIORAL

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.

Also known as: social problem-solving
Problem-solving

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Living in the UK
  • Fluent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sheffield

Sheffield, South Yorkshire, S1 2LT, United Kingdom

Location

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Laura Castillo-Eito

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Intervention and control group. Participants are randomised to one of them.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 17, 2019

Study Start

October 25, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

November 20, 2020

Record last verified: 2019-10

Locations