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Completed

NCT Number: NCT04497506

Wise Interventions 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.

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Key information

Conditions

Cyberbullying Aggression Appetitive Behavior Behavior Behavior, Animal Behavioral Symptoms Bullying Grooming Harassment, Non-Sexual Risk Behavior Risk-Taking Social Behavior

Age range

11 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Deusto

Bilbao, Bizkaia, 48080, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Other outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

University of Deusto

Other

Collaborators

  • Fundación BBVA

Registry information

Official study title

Wise Interventions for Adolescents and Young People in the Digital Society

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2020
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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