Clinical trial NCT04497506: Wise Interventions in the Digital Society
Official title: Wise Interventions for Adolescents and Young People in the Digital Society
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cyberbullying
Grooming
Risk Behavior
Keywords: Adolescence
Youth
Cyberbullying
Grooming
Sexting
Prevention
Lead sponsor: University of Deusto
Sponsor class: OTHER
Collaborators: name: Fundación BBVA
First posted: 2020-08-04
Enrollment: 1212
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change from baseline scores of the Cyber Bullying Questionnaire (CBQ; Calvete et al., 2010; Gámez-Guadix, Villa-George, & Calvete, 2014)
timeFrame: Baseline, 3 months, and 6 months.
measure: Change from baseline scores of the Online Sexual Solicitation and Interaction of Minors with Adults Questionnaire (Gámez-Guadix, De Santisteban, & Alcazar, 2017).
timeFrame: Baseline, 3 months, and 6 months.
measure: Change from baseline scores of the Sexting questionnaire (Gámez-Guadix, Almendros, Borrajo, & Calvete, 2015).
timeFrame: Baseline, 3 months, and 6 months.
Secondary outcomes:
measure: Change from baseline scores of the Online Prosocial Behavior Scale (OPBS; Erreygers, Vandebosch, Vranjes, Baillien y De Witte, 2017).
timeFrame: Baseline, 3 months, and 6 months.
measure: Change from baseline scores of the Cyber Dating Abuse Questionnaire (CDAQ; Borrajo et al., 2015)
timeFrame: Baseline, 3 months, and 6 months (only in participants with a dating relationship).
measure: Change from baseline scores of the reduced version of the Center for Epidemiological Studies Depression (CES-D; Rueda-Jaimes et al., 2009).
timeFrame: Baseline, 3 months, and 6 months.
Other outcomes:
measure: Change from baseline scores of attitude towards cyberbullying measure
timeFrame: Baseline, intervention day, 3 months, and 6 months.
measure: Change from baseline scores of attitude towards different courses of action measure
timeFrame: Baseline, intervention day, 3 months, and 6 months.
measure: Change from baseline scores of the anticipation of reactions and behaviors measure
timeFrame: Baseline, intervention day, 3 months, and 6 months.
measure: Change from baseline scores of Entity and incremental theories (Levy, Stroessner, & Dweck, 1998).
timeFrame: Baseline, intervention day, 3 months, and 6 months.
Locations:
city: Bilbao
country: Spain
facility: University of Deusto
state: Bizkaia
Study officials:
affiliation: University of Deusto
name: Esther Calvete, PhD
role: PRINCIPAL_INVESTIGATOR
References: