CyberbullyingResilienceNCT04509531
Building Resilience in Cyberbullying Victims
A study testing Wise Intervention (SA, ITP and resilience) and Standard preventive intervention in people with Cyberbullying and Depression, run by University of Deusto at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cyberbullying, Depression, Non Suicidal Self Injury
- What is being tested?
- Wise Intervention (SA, ITP and resilience) and Standard preventive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Spanish or Basque understanding
- Permission by parents
- Voluntarity
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Resilience Against Cyberbullying Victimization
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.
Read the 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.
- Being tested
- Wise Intervention (SA, ITP and resilience), Standard preventive intervention
- Keywords
- Adolescence, Prevention, Cyberbullying, Depression, Non Suicidal Self Injury, Social Anxiety, Eating Disorders
- Medical subject headings
- Cyberbullying, Depression, Self-Injurious Behavior, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wise Intervention (SA, ITP and resilience)Behavioural
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 interventionBehavioural
The control intervention will involve scientific information and education about internet risks such as sexting and grooming.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: SA, ITP and Resilience | Experimental | 1 hour Wise intervention (based on SA, ITP and resilience) consisting on several tasks to be completed online individually. Receives: Behavioral: Wise Intervention (SA, ITP and resilience) |
| Standard preventive intervention | Other | 1 hour educational intervention (about internet risks such as sexting and grooming) consisting on several tasks to be completed online individually. Receives: Behavioral: Standard preventive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 months, and 6 months.
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).
Measured: Baseline, 3 months, and 6 months.
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).
Measured: Baseline, 3 months, and 6 months.
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).
Measured: Baseline, 3 months, and 6 months.
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).
Measured: Baseline, 3 months, and 6 months.
Secondary outcomes (5)
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).
Measured: Baseline, 1 hour, 3 months, and 6 months.
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.
Measured: Baseline, 1 hour, 3 months, and 6 months.
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.
Measured: Baseline, 1 hour, 3 months, and 6 months.
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).
Measured: Baseline, 1 hour, 3 months, and 6 months.
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).
Measured: Baseline, 1 hour, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start15 Sep 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CyberbullyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Alicia Koplowitz
- Responsible party
- Principal investigator, Esther Calvete, University of Deusto
- Investigators
- Esther Calvete, PhD, Principal investigator, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509531
- Sponsor's protocol ID
- 2019-0000222
- Other IDs
- 2019
- Acronym
- Resilience
- Status last verified
- Sep 2021
- First submitted
- 30 Jul 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be available at OSF when the results of the study are published.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Resilience Against Cyberbullying Victimization
- ClinicalTrials.gov ID
- NCT04509531
- Acronym / sponsor ID
- Resilience / 2019-0000222
- Keywords
- Adolescence, Prevention, Cyberbullying, Depression, Non Suicidal Self Injury, Social Anxiety, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Collaborators
- Fundación Alicia Koplowitz
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: SA, ITP and Resilience | Experimental | Behavioral: Wise Intervention (SA, ITP and resilience)1 hour Wise intervention (based on SA, ITP and resilience) consisting on several tasks to be completed online individually. |
| Standard preventive intervention | Other | Behavioral: Standard preventive intervention1 hour educational intervention (about internet risks such as sexting and grooming) consisting on several tasks to be completed online individually. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Spanish or Basque understanding
- Permission by parents
- Voluntarity
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Experimental: SA, ITP and Resilience |
| Standard preventive interventionThe control intervention will involve scientific information and education about internet risks such as sexting and grooming. | Behavioural | Standard preventive intervention |
Primary outcome
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).
Change from baseline scores of the Functional Assessment of Self-Mutilation (FASM; Lloyd, Kelley & Hope, 1997)
Time frame: Baseline, 3 months, and 6 months.
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).
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).
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)
Time frame: Baseline, 3 months, and 6 months.
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)
Time frame: Baseline, 3 months, and 6 months.
Self reported symptomatology associated with eating disorders through 8 items, with a six-point response scale ranging from 1 (never) to 6 (always).
5 secondary outcomes
Change from baseline scores of Entity and incremental theories (Levy, Stroessner, & Dweck, 1998).
Time frame: Baseline, 1 hour, 3 months, and 6 months.
Change from baseline scores of attitude towards cyberbullying measure
Time frame: Baseline, 1 hour, 3 months, and 6 months.
Change from baseline scores of attitude towards different courses of action measure
Time frame: Baseline, 1 hour, 3 months, and 6 months.
Change from baseline scores of the anticipation of reactions and behaviors measure
Time frame: Baseline, 1 hour, 3 months, and 6 months.
Change from baseline scores of the intention to use different strategies when the adolescent is exposed to diverse stressors
Time frame: Baseline, 1 hour, 3 months, and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Yes. Raw data will be available at OSF when the results of the study are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Calvete, PhD principal investigator
University of Deusto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wise Intervention (SA, ITP and resilience) and Standard preventive intervention in people with Cyberbullying and Depression, run by University of Deusto at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.