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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04509531
Other study ID # 2019-0000222
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date July 31, 2021

Study information

Verified date September 2021
Source University of Deusto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the effectiveness of a wise intervention based on self-affirmation (SA) and Implicit Theories of Personality (ITP) building resilience in victims. Half of the participants will receive the experimental intervention, while the other half will receive a control intervention.


Description:

Bullying victimization can harm victims' mental health. Numerous studies have shown that, when an adolescent is a victim of cyberbullying, the risk of developing numerous mental health problems increases. Tackling the problem of cyberbullying victims' worsening mental health involves at least (1) reducing bullying itself, as this would reduce the prevalence of victimization, and (2) building resilience in the victims so that their mental health does not worsen. In recent years, a number of preventive interventions have been developed aimed at reducing cyberbullying but not so much focused on building resilience in the victims. 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 extend the previous findings to the mental health effects of online victimization in adolescents. In this project it will be designed and evaluated the effectiveness of an wise intervention aimed at (1) reducing online bullying, as this would reduce the prevalence of victimization; and (2) building resilience in victims so that the negative impact of victimization on their mental health will be reduced. The secondary objective will be to evaluate the moderating role of gender and the degree of development in the effects of the intervention.The study will involve the evaluation of the intervention in a sample of around 600 adolescents randomly allocated to experimental and control condition.


Recruitment information / eligibility

Status Completed
Enrollment 850
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 19 Years
Eligibility Inclusion Criteria: - Spanish or Basque understanding - Permission by parents - Voluntarity Exclusion Criteria: -

Study Design


Intervention

Behavioral:
Wise Intervention (SA, ITP and resilience)
The intervention will be based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection. This will include activities such as reading scientific information about social behavior and its role in people's well-being and mental health, the meaning of online victimization experiences and ways to react to them, experiences of other young people of their age, and self-persuasion exercises that involve an active commitment to change. Furthermore, it 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
The control intervention will involve scientific information and education about internet risks such as sexting and grooming.

Locations

Country Name City State
Spain University of Deusto Bilbao Bizkaia

Sponsors (2)

Lead Sponsor Collaborator
University of Deusto Fundación Alicia Koplowitz

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary Change from baseline scores of the Functional Assessment of Self-Mutilation (FASM; Lloyd, Kelley & Hope, 1997) Self reported levels of Non-Suicidal Self-Harm (NSSH). The 6 most representative items will be used. Each item is scored 0-4 (0 = 0 times; 4 = > 11 times). Baseline, 3 months, and 6 months.
Primary 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). Baseline, 3 months, and 6 months.
Primary Change from baseline scores of the reduced Spanish version of the Social Anxiety Scale for Adolescents (SAS-A; La Greca & Lopez, 1998; Nelemans et al., 2019) Self reported symptomatology of social anxiety through 12 items, with a five-point response scale ranging from 1 (not at all) to 5 (all the time). Baseline, 3 months, and 6 months.
Primary Change from baseline scores of the reduced version of the Eating Attitudes Test (EAT; Garner & Garfinkel, 1979; EAT-8, Richter, Strauss, Braehler, Altmann & Berger, 2016) Self reported symptomatology associated with eating disorders through 8 items, with a six-point response scale ranging from 1 (never) to 6 (always). Baseline, 3 months, and 6 months.
Secondary Change from baseline scores of Entity and incremental theories (Levy, Stroessner, & Dweck, 1998). 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, 1 hour, 3 months, and 6 months.
Secondary Change from baseline scores of attitude towards cyberbullying measure 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, 1 hour, 3 months, and 6 months.
Secondary Change from baseline scores of attitude towards different courses of action measure 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, 1 hour, 3 months, and 6 months.
Secondary Change from baseline scores of the anticipation of reactions and behaviors measure 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, 1 hour, 3 months, and 6 months.
Secondary Change from baseline scores of the intention to use different strategies when the adolescent is exposed to diverse stressors Self reported ad hoc measures developed by the research team of the intention to use different strategies when the adolescent is exposed to diverse stressors, participants will complete six items on a four-point response scale ranging from 0 (never or almost never) to 3 (always or almost always). Baseline, 1 hour, 3 months, and 6 months.
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