- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04497506
Wise Interventions in the Digital Society
May 9, 2023 updated by: Esther Calvete, University of Deusto
Wise Interventions for Adolescents and Young People in the Digital Society
This study evaluates the effectiveness of a Wise intervention based on self-affirmation (SA) and Implicit Theories of Personality (ITP) in Spanish adolescents and young people.
Half of participants will receive the ITP and self-affirmation intervention, while the other half will receive a control intervention.
Study Overview
Status
Completed
Conditions
Detailed Description
Adolescence is a period that involves important transitions and learning opportunities.
Adolescents and young people learn and develop new competencies and facets in the digital society.
Hence, a large part of their social relationships takes place through social media.This offers them numerous positive opportunities for the emotional and social development of adolescents and young people.
They can develop positive interactions through prosocial behaviors, empathy, and social support towards others.
At the same time it is not without potential risks, especially in adolescence, a stage of psychological vulnerability for risky behaviors.
Very recently, interest in scientific social psychology has grown due to a new approach to interventions, which have been called "wise interventions."
This approach involves a set of rigorous techniques, based on theory and research, that address specific psychological processes to help people thrive in various life environments.
The main objective of this project is to design and evaluate the effectiveness of a wise intervention based on self-affirmation (SA) and Implicit Theories of Personality (ITP) to promote various online prosocial behaviors (help, empathy, collaboration) and prevent online risk and harassment behaviors (online bullying, sexting, grooming).
Secondary objectives are (1) to assess the moderating role of gender and the degree of evolutionary development of adolescents and young people, and (2) to evaluate potential mediating mechanisms for the effectiveness of the interventions.
The study will involve the evaluation of the intervention in a sample of around 1000 young and adolescents randomly allocated to experimental and control condition.
Study Type
Interventional
Enrollment (Actual)
1212
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bizkaia
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Bilbao, Bizkaia, Spain, 48080
- University of Deusto
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Informed consent by the adolescents and their parents.
- To be fluent in Spanish and/or Euskera.
Exclusion Criteria:
- Lack of permission by parents and the adolescent.
- Lack of understanding of the instructions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self-affirmation and Incremental theory of personality
1 hour Wise intervention (based on SA and ITP) consisting on several tasks to be completed online individually.
|
The intervention designed to promote prosocial behavior and reduce online risks is based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection.
It includes two components: a self-affirmation activity and an ITP intervention.
The SA component includes a list of values so that they could choose the two or three most important for them.
Next, they are asked to write why those selected values are the most important to them.
The ITP component includes activities such as reading scientific information about social behavior and its role in people's well-being, the meaning and value of online risk behaviors through stories and videos of the experiences of other young people of their age, and self-persuasion exercises that involve an active commitment to change.
|
Other: Standard preventive intervention
1 hour educational intervention (about stress management) consisting on several tasks to be completed online individually.
|
It consists of an educational intervention that provides a number of strategies to manage everyday conflicts among adolescents.
This intervention teaches them new ways to manage these difficulties through different actions (relaxation, distraction, sports, etc.).
Finally, they are asked to plan the strategies they will use in the future in the face of some difficulties and to recommend some guidelines for another adolescent who may be going through a similar situation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline scores of the Cyber Bullying Questionnaire (CBQ; Calvete et al., 2010; Gámez-Guadix, Villa-George, & Calvete, 2014)
Time Frame: Baseline, 3 months, and 6 months.
|
Self reported levels of perpetration (9 items) and victimization (9 items) of peer cyber aggression.
Each item is scored 0-4 (0 = never; 4 = almost every week).
|
Baseline, 3 months, and 6 months.
|
Change from baseline scores of the Online Sexual Solicitation and Interaction of Minors with Adults Questionnaire (Gámez-Guadix, De Santisteban, & Alcazar, 2017).
Time Frame: Baseline, 3 months, and 6 months.
|
Self reported items that assess the sexual interactions with an adult (10 items).
Items are rated on a four-point response scale ranging from 0 (never) to 3 (6 or more times).
|
Baseline, 3 months, and 6 months.
|
Change from baseline scores of the Sexting questionnaire (Gámez-Guadix, Almendros, Borrajo, & Calvete, 2015).
Time Frame: Baseline, 3 months, and 6 months.
|
Self reported items about sending photos, information or videos of sexual or intimate content to three potential recipients: a partner, a friend and someone they have met on Internet but not in person (3 items).
A five-point response scale was used ranging from 0 (never) to 4 (7 or more times).
|
Baseline, 3 months, and 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline scores of the Online Prosocial Behavior Scale (OPBS; Erreygers, Vandebosch, Vranjes, Baillien y De Witte, 2017).
Time Frame: Baseline, 3 months, and 6 months.
|
Self reported items about online prosocial behaviors (4 items).
A five-point response scale was used ranging from 1 (never) to 5 (every day).
|
Baseline, 3 months, and 6 months.
|
Change from baseline scores of the Cyber Dating Abuse Questionnaire (CDAQ; Borrajo et al., 2015)
Time Frame: Baseline, 3 months, and 6 months (only in participants with a dating relationship).
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Self reported items about dating aggressive behaviors of perpetration (4 items) and victimization (4 items).
Items scored 0-3 (0 = never; 3 = almost always).
|
Baseline, 3 months, and 6 months (only in participants with a dating relationship).
|
Change from baseline scores of the reduced version of the Center for Epidemiological Studies Depression (CES-D; Rueda-Jaimes et al., 2009).
Time Frame: Baseline, 3 months, and 6 months.
|
Self reported symptoms of depression through 10 items, with a four-point response scale ranging from 0 (practically never) to 3 (almost all the time).
|
Baseline, 3 months, and 6 months.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline scores of attitude towards cyberbullying measure
Time Frame: Baseline, intervention day, 3 months, and 6 months.
|
Self reported ad hoc measures developed by the research team of the attitude towards cyberbullying.
The participants will classify one situation of cyberbullying through adjectives using the semantic differential technique with a response range of 7 points.
|
Baseline, intervention day, 3 months, and 6 months.
|
Change from baseline scores of attitude towards different courses of action measure
Time Frame: Baseline, intervention day, 3 months, and 6 months.
|
Self reported ad hoc measures developed by the research team of the attitude towards different courses of action when the adolescent witnesses cyberbullying.
The participants will rate four different ways to react to cyberbullying through semantic differential items.
|
Baseline, intervention day, 3 months, and 6 months.
|
Change from baseline scores of the anticipation of reactions and behaviors measure
Time Frame: Baseline, intervention day, 3 months, and 6 months.
|
Self reported ad hoc measures developed by the research team of the anticipation of reactions and behaviors when the adolescent is a witness.
The participants will answer seven items on a five-point response scale ranging from 0 (totally disagree) to 3 (totally agree).
|
Baseline, intervention day, 3 months, and 6 months.
|
Change from baseline scores of Entity and incremental theories (Levy, Stroessner, & Dweck, 1998).
Time Frame: Baseline, intervention day, 3 months, and 6 months.
|
Entity and incremental theories will be evaluated using eight items adapted to the situations of bullying in schools.
Items are rated on a six-point scale ranging from 1 (strongly disagree) to 6 (strongly agree).
|
Baseline, intervention day, 3 months, and 6 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Esther Calvete, PhD, University of Deusto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2020
Primary Completion (Actual)
June 15, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
July 31, 2020
First Posted (Actual)
August 4, 2020
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR[18]_SOC_0096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Raw data will be available at OSF when the results of the study are published.
IPD Sharing Time Frame
The study protocol and informed consent protocol will be published at clinicaltrials.org
Data will be available at OSF when the results are published.
IPD Sharing Access Criteria
Public
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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