Wise Interventions in the Digital Society

NCT04497506 | Completed

• 1 other identifier: PR[18]_SOC_0096
• Study Type: interventional
• Target: 1,212
• Locations: 1 country
• Sites: 1

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.

Conditions

Cyberbullying; Grooming; Risk Behavior

Keywords

Adolescence; Youth; Cyberbullying; Grooming; Sexting; Prevention

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  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 Outcomes (3)

• Change from baseline scores of the Online Prosocial Behavior Scale (OPBS; Erreygers, Vandebosch, Vranjes, Baillien y De Witte, 2017).

  Baseline, 3 months, and 6 months.

• Change from baseline scores of the Cyber Dating Abuse Questionnaire (CDAQ; Borrajo et al., 2015)

  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).

  Baseline, 3 months, and 6 months.

Other Outcomes (4)

• Change from baseline scores of attitude towards cyberbullying measure

  Baseline, intervention day, 3 months, and 6 months.

• Change from baseline scores of attitude towards different courses of action measure

  Baseline, intervention day, 3 months, and 6 months.

• Change from baseline scores of the anticipation of reactions and behaviors measure

  Baseline, intervention day, 3 months, and 6 months.

Study Arms (2)

Self-affirmation and Incremental theory of personality

EXPERIMENTAL

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)

Standard preventive intervention

OTHER

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

Behavioral: Standard preventive intervention

Interventions

Wise Intervention (Self-affirmation and Incremental theory of personality) BEHAVIORAL

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.

Self-affirmation and Incremental theory of personality

Standard preventive intervention BEHAVIORAL

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.

Standard preventive intervention

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed consent by the adolescents and their parents.
• To be fluent in Spanish and/or Euskera.

You may not qualify if:

• Lack of permission by parents and the adolescent.
• Lack of understanding of the instructions.

Sponsors & Collaborators

• University of Deusto: lead
• Fundación BBVA: collaborator

Study Sites (1)

University of Deusto

Bilbao, Bizkaia, 48080, Spain

Location

MeSH Terms

Conditions

Cyberbullying; Grooming; Risk-Taking

Condition Hierarchy (Ancestors)

Bullying; Aggression; Behavioral Symptoms; Behavior; Harassment, Non-Sexual; Social Behavior; Appetitive Behavior; Behavior, Animal

Study Officials

• Esther Calvete, PhD

  University of Deusto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Deusto Stress Research Team, University of Deusto

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 4, 2020
• Study Start: September 15, 2020
• Primary Completion: June 15, 2021
• Study Completion: July 31, 2021
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Public

Locations

ES (1)