Building Resilience in Cyberbullying Victims (Resilience)
Primary Purpose
Cyberbullying, Depression, Non Suicidal Self Injury
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Wise Intervention (SA, ITP and resilience)
Standard preventive intervention
Sponsored by
About this trial
This is an interventional prevention trial for Cyberbullying focused on measuring Adolescence, Prevention, Cyberbullying, Depression, Non Suicidal Self Injury, Social Anxiety, Eating Disorders
Eligibility Criteria
Inclusion Criteria:
- Spanish or Basque understanding
- Permission by parents
- Voluntarity
Exclusion Criteria:
-
Sites / Locations
- University of Deusto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental: SA, ITP and Resilience
Standard preventive intervention
Arm Description
1 hour Wise intervention (based on SA, ITP and resilience) consisting on several tasks to be completed online individually.
1 hour educational intervention (about internet risks such as sexting and grooming) 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 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).
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).
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).
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).
Secondary Outcome Measures
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).
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.
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.
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).
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).
Full Information
NCT ID
NCT04509531
First Posted
July 30, 2020
Last Updated
September 27, 2021
Sponsor
University of Deusto
Collaborators
Fundación Alicia Koplowitz
1. Study Identification
Unique Protocol Identification Number
NCT04509531
Brief Title
Building Resilience in Cyberbullying Victims
Acronym
Resilience
Official Title
Development of Resilience Against Cyberbullying Victimization
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
July 31, 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 Alicia Koplowitz
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) building resilience in victims. Half of the participants will receive the experimental intervention, while the other half will receive a control intervention.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyberbullying, Depression, Non Suicidal Self Injury, Social Anxiety, Eating Disorders
Keywords
Adolescence, Prevention, Cyberbullying, Depression, Non Suicidal Self Injury, Social Anxiety, Eating Disorders
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 and resilience condition) versus control condition (anti-grooming/sexting 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
850 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: SA, ITP and Resilience
Arm Type
Experimental
Arm Description
1 hour Wise intervention (based on SA, ITP and resilience) consisting on several tasks to be completed online individually.
Arm Title
Standard preventive intervention
Arm Type
Other
Arm Description
1 hour educational intervention (about internet risks such as sexting and grooming) consisting on several tasks to be completed online individually.
Intervention Type
Behavioral
Intervention Name(s)
Wise Intervention (SA, ITP and resilience)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard preventive intervention
Intervention Description
The control intervention will involve scientific information and education about internet risks such as sexting and grooming.
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 Functional Assessment of Self-Mutilation (FASM; Lloyd, Kelley & Hope, 1997)
Description
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).
Time Frame
Baseline, 3 months, and 6 months.
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.
Title
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)
Description
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).
Time Frame
Baseline, 3 months, and 6 months.
Title
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)
Description
Self reported symptomatology associated with eating disorders through 8 items, with a six-point response scale ranging from 1 (never) to 6 (always).
Time Frame
Baseline, 3 months, and 6 months.
Secondary Outcome Measure Information:
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, 1 hour, 3 months, and 6 months.
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, 1 hour, 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, 1 hour, 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, 1 hour, 3 months, and 6 months.
Title
Change from baseline scores of the intention to use different strategies when the adolescent is exposed to diverse stressors
Description
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).
Time Frame
Baseline, 1 hour, 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:
Spanish or Basque understanding
Permission by parents
Voluntarity
Exclusion Criteria:
-
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
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Building Resilience in Cyberbullying Victims
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