search
Back to results

Wise Interventions in the Digital Society

Primary Purpose

Cyberbullying, Grooming, Risk Behavior

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Wise Intervention (Self-affirmation and Incremental theory of personality)
Standard preventive intervention
Sponsored by
University of Deusto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cyberbullying focused on measuring Adolescence, Youth, Cyberbullying, Grooming, Sexting, Prevention

Eligibility Criteria

11 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Deusto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Self-affirmation and Incremental theory of personality

Standard preventive intervention

Arm Description

1 hour Wise intervention (based on SA and ITP) consisting on several tasks to be completed online individually.

1 hour educational intervention (about stress management) consisting on several tasks to be completed online individually.

Outcomes

Primary Outcome Measures

Change from baseline scores of the Cyber Bullying Questionnaire (CBQ; Calvete et al., 2010; Gámez-Guadix, Villa-George, & Calvete, 2014)
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).
Change from baseline scores of the Online Sexual Solicitation and Interaction of Minors with Adults Questionnaire (Gámez-Guadix, De Santisteban, & Alcazar, 2017).
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).
Change from baseline scores of the Sexting questionnaire (Gámez-Guadix, Almendros, Borrajo, & Calvete, 2015).
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).

Secondary Outcome Measures

Change from baseline scores of the Online Prosocial Behavior Scale (OPBS; Erreygers, Vandebosch, Vranjes, Baillien y De Witte, 2017).
Self reported items about online prosocial behaviors (4 items). A five-point response scale was used ranging from 1 (never) to 5 (every day).
Change from baseline scores of the Cyber Dating Abuse Questionnaire (CDAQ; Borrajo et al., 2015)
Self reported items about dating aggressive behaviors of perpetration (4 items) and victimization (4 items). Items scored 0-3 (0 = never; 3 = almost always).
Change from baseline scores of the reduced version of the Center for Epidemiological Studies Depression (CES-D; Rueda-Jaimes et al., 2009).
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).

Full Information

First Posted
July 28, 2020
Last Updated
May 9, 2023
Sponsor
University of Deusto
Collaborators
Fundación BBVA
search

1. Study Identification

Unique Protocol Identification Number
NCT04497506
Brief Title
Wise Interventions in the Digital Society
Official Title
Wise Interventions for Adolescents and Young People in the Digital Society
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Deusto
Collaborators
Fundación BBVA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyberbullying, Grooming, Risk Behavior
Keywords
Adolescence, Youth, Cyberbullying, Grooming, Sexting, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized in a 1:1 ratio blocked by gender to one of two groups: experimental condition (SA+ITP) versus control condition (anti-stress condition) in parallel for the duration of the study.
Masking
ParticipantOutcomes Assessor
Masking Description
Allocation will be concealed to the participants, researchers -who will be in class the assessment days if possible depending on the Covid-19 scenario- and teachers.
Allocation
Randomized
Enrollment
1212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-affirmation and Incremental theory of personality
Arm Type
Experimental
Arm Description
1 hour Wise intervention (based on SA and ITP) consisting on several tasks to be completed online individually.
Arm Title
Standard preventive intervention
Arm Type
Other
Arm Description
1 hour educational intervention (about stress management) consisting on several tasks to be completed online individually.
Intervention Type
Behavioral
Intervention Name(s)
Wise Intervention (Self-affirmation and Incremental theory of personality)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard preventive intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline scores of the Cyber Bullying Questionnaire (CBQ; Calvete et al., 2010; Gámez-Guadix, Villa-George, & Calvete, 2014)
Description
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).
Time Frame
Baseline, 3 months, and 6 months.
Title
Change from baseline scores of the Online Sexual Solicitation and Interaction of Minors with Adults Questionnaire (Gámez-Guadix, De Santisteban, & Alcazar, 2017).
Description
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).
Time Frame
Baseline, 3 months, and 6 months.
Title
Change from baseline scores of the Sexting questionnaire (Gámez-Guadix, Almendros, Borrajo, & Calvete, 2015).
Description
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).
Time Frame
Baseline, 3 months, and 6 months.
Secondary Outcome Measure Information:
Title
Change from baseline scores of the Online Prosocial Behavior Scale (OPBS; Erreygers, Vandebosch, Vranjes, Baillien y De Witte, 2017).
Description
Self reported items about online prosocial behaviors (4 items). A five-point response scale was used ranging from 1 (never) to 5 (every day).
Time Frame
Baseline, 3 months, and 6 months.
Title
Change from baseline scores of the Cyber Dating Abuse Questionnaire (CDAQ; Borrajo et al., 2015)
Description
Self reported items about dating aggressive behaviors of perpetration (4 items) and victimization (4 items). Items scored 0-3 (0 = never; 3 = almost always).
Time Frame
Baseline, 3 months, and 6 months (only in participants with a dating relationship).
Title
Change from baseline scores of the reduced version of the Center for Epidemiological Studies Depression (CES-D; Rueda-Jaimes et al., 2009).
Description
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).
Time Frame
Baseline, 3 months, and 6 months.
Other Pre-specified Outcome Measures:
Title
Change from baseline scores of attitude towards cyberbullying measure
Description
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.
Time Frame
Baseline, intervention day, 3 months, and 6 months.
Title
Change from baseline scores of attitude towards different courses of action measure
Description
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.
Time Frame
Baseline, intervention day, 3 months, and 6 months.
Title
Change from baseline scores of the anticipation of reactions and behaviors measure
Description
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).
Time Frame
Baseline, intervention day, 3 months, and 6 months.
Title
Change from baseline scores of Entity and incremental theories (Levy, Stroessner, & Dweck, 1998).
Description
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).
Time Frame
Baseline, intervention day, 3 months, and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Calvete, PhD
Organizational Affiliation
University of Deusto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Deusto
City
Bilbao
State/Province
Bizkaia
ZIP/Postal Code
48080
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Wise Interventions in the Digital Society

We'll reach out to this number within 24 hrs