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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48080
        • University of Deusto

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Wise Intervention (Self-affirmation and Incremental theory of personality)
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.
Behavioral: Standard preventive intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Deusto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundación BBVA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Risk Behavior

Clinical Trials on Wise Intervention (Self-affirmation and Incremental theory of personality)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings