Violence in AdolescenceNCT03411564

Lights, Camera and Action Against Dating Violence (Lights4Violence)

A study testing Filming Together to See Ourselves in a New 'Present' in people with Violence in Adolescence, run by University of Alicante at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Lights4Violence aims to promote adolescents' capabilities to improve their intimate relationships with peers through different participation approach activities. In order to do that, it is planned to perform a longitudinal quasi-experimental educational intervention study with a quantitative evaluation in 5 different… Read more about this study

Who is it for?: Ages 13 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Violence in Adolescence
What is being tested?: Filming Together to See Ourselves in a New 'Present'
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,555 participants
Where: 1 siteSpain
Study dates: 1 Oct 2018to 20 Jul 2019
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 13 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Boys and girls aged 13 to 17 years, studying in the targeted secondary schools in each city.

Who cannot join

Students with language barriers

Trial locations and contacts

1 site in 1 country.

Spain1 site

University of Alicante
Alicante, 03570

Other trials in Spain

About this study

Official title: Lights, Camera and Action Against Dating Violence!

Read the detailed description

DESIGN: Longitudinal quasi-experimental educational intervention study with a quantitative evaluation.

PILOT STUDY (June - July of 2018): Prior to the implementation of the program in the whole sample, an evaluation pilot study will be carried out with a minimum of 20 adolescents (10 boys and 10 girls) who are finishing the same grade as those who will later receive the intervention in August-September 2018. This pilot study focuses on:

Determining the competencies and capacities of the participants to carry out the on-line questionnaire.
Calculating the time it takes the students to complete the questionnaire
Carrying out an internal validation of the questionnaire (that is, are there different responses to similar questions?) among the study population by calculating internal consistency and validity indices.

The obtained results will be shared among the members of the consortium in order to evaluate possible adaptations considered necessary.

PARTICIPANTS: Two groups of students will be assigned either an intervention or control condition, respectively. The intervention group will be composed of boys and girls aged 13 years or more, studying in secondary schools in the city. The control group will be made up of students from other centers with similar socioeconomic characteristics (relating to social characteristics and school location) to the centers. The evaluation survey will be given to a total of 300 students per country, 120 to 150 from the intervention group and 150 from the control group.

The schools selection will be carried out by contacting different secondary education centers from the city as considered appropriate by the members of the research team (non-random sample). The program contents will be presented and the possibility to participate will be offered. The intervention group will be selected from among the students whose centers accept participation in the study. The control group will be made up of students from secondary education centers with social characteristics similar to the centers that will be implement the intervention. The students from the control and the intervention groups will have the same composition in terms of age, sex and academic course. It is recommended that the control and intervention groups belong to different educational centers in order to avoid contamination. It should be mentioned that this is a wait-list control study, that is, those centers that participate in the project as a part of the control group should be offered the possibility of participating in teacher training, access to guides and manuals generated by the project as well as carrying out the intervention in the future (i.e., when the intervention is finished in the intervention group) with Lights4Violence researchers' support if the participants consider it necessary and the research team have the capacity to do it.

Conditions: Violence in Adolescence
Being tested: Filming Together to See Ourselves in a New 'Present'
Keywords: dating violence, health promotion, educational intervention, health assets, participation action research

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Filming Together to See Ourselves in a New 'Present'Other
PHASE 0. PRIOR TRAINING 1) Promoting protective assets related to violence together. 10-hour training session with 10-15 secondary school teachers; 2) Identifying our own protective assets against violence. This training activity will be addressed to targeted students. The activity will be carried out in four sessions of 1 hour in duration.
PHASE 1.PRE-PRODUCTION. 1) Participant activity on building story arguments; and 2) Construction of a technical and literary guide to the video capsules.
PHASE 2: PRODUCTION.- 1) Rehearsal of the script developed by each group; 2) Preparation and selection of environment, wardrobe and characterization of the roles and, 3) Filming of the video capsules.
PHASE 3: POST-PRODUCTION.- This phase consists of putting together the short film using the various video capsules.
PHASE 4: DISSEMINATION. A short film exhibition to provide a space where participants can present their video capsules and briefly explain the production process.

Study groups in NCT03411564
Study group	Role	What they receive
Group 1	Experimental	Students enrolled in one or two targeted secondary schools in each city who are going to receive the intervention (workshop) Receives: Other: Filming Together to See Ourselves in a New 'Present'
Grup 0	No intervention	Students from other centers with similar socioeconomic characteristics (relating to social characteristics and school location) to the centers.

What is being measured

The primary outcome is the main question the study is designed to answer.

Attitudes against sexism
The Ambivalent Sexism Inventory, a 22-item self-report measure of sexism. Respondents indicate their level of agreement, on a 6-point Likert-type scale, with various statements. It is composed of two sub-scales that may be independently calculated for sub-scale scores or may be averaged for an overall composite sexism score. The first sub-scale is the hostile sexism scale, which is composed of 11 items designed to assess an individual's position on the dimensions of dominative paternalism, competitive gender differentiation, and heterosexual hostility, as previously defined. The second sub-scale is the benevolent sexism scale, which is composed of 11 items that aim to assess an individual's position on the dimensions of protective paternalism, complementary gender differentiation, and heterosexual intimacy.
Measured: 1-6 months after the intervention
Level of Aggression
Aggression Questionnaire-Refined measures four aspects of aggression: Physical Aggression and Verbal Aggression, which involve hurting or harming others and represent the instrumental or motor component of behavior; Hostility, which consists of feelings of ill-will and injustice and represents the cognitive component of behavior; and Anger, which involves physiological arousal and preparation for aggression and represents the emotional or affective component of behavior.
Measured: 1-6 months after the intervention
Intolerance towards intimate partner violence
The Maudsley Violence Questionnaire measures a range of cognitions, relating to violent behavior, drawn from clinical and theoretical perspectives. This measure integrates justification of violence in response to threatened self-esteem and the legitimization of violence as central elements. Participants are asked to rate as True or False a series of statements. The scale is comprised of two factors: 'machismo' (42 items) and 'acceptance of violence' (14 items).
Measured: 1-6 months after the intervention

Secondary outcomes (4)

Problem Solving capacity
The Social Problem-Solving Inventory-Revised Scale is scale of 25 items. Items are answered in a 5-point Likert-type scale, from "this is not true" to "extremely true". Items are distributed in five sub-scales (5 items in each subscale) that evaluate functional and dysfunctional aspects of the ability to problem solve. The functional dimension is evaluated through two sub-scales: Positive Problem Orientation and Rational Problem Resolution; while the dysfunctional dimension is evaluated through the sub-scales Negative Problem Orientation, Avoidance Style and Impulsivity/Carelessness Style. These five dimensions allow obtaining a total score that corresponds to a general estimation of the ability to solve problems, in addition to the average scores in each of the dimensions.
Measured: 1-6 months after the intervention
Interpersonal reactivity
Interpersonal Reactivity Index structure to be made up of four independent dimensions of seven items each: a) Fantasy, which denotes the tendency of the subjects to identify with fictitious subjects such as characters from books and movies, b) Perspective taking, which contains items that reflect the tendency or ability of the subjects to adopt the perspective or point of view of other people, c) Empathetic concerns, which contains items that evaluate the subject's tendencies to experience sensations of compassion and concern towards others, and d) Personal distress, which includes items that indicate that subjects experience feelings of discomfort and anxiety when witnessing the negative experiences of others. Respondents rate how well several statements describe them, on a 5-point Likert type scale from "does not describe me well" to "describes me very well".
Measured: 1-6 months after the intervention
Self-esteem
Rosenberg Self-Esteem Scale is a 10-item scale that measures global self-worth by assessing both positive and negative feelings about the self. The scale is believed to be unidimensional. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree.
Measured: 1-6 months after the intervention
Assertiveness
Measured by the Assertive Interpersonal Schema Questionnaire with 21 items, assesses four dimensions that refer to external emotional support (5 items), practical personal ability (4 items), interpersonal management (8 items) and affective personal ability (4 items). Items are rated on a 1 (completely false) to 5 (completely true) Likert-type scale. Scores on the questionnaire higher than the average in each of the dimensions indicate good personal adjustment and adequate capacity for assertiveness.
Measured: 1-6 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201820 Jul 2019

First posted26 Jan 2018
Study start1 Oct 2018
Primary completion30 Jan 2019
Study completion20 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Violence in AdolescenceStudies 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: Non-randomised
Intervention model: Parallel groups
Model description: Longitudinal quasi-experimental educational intervention study. The evaluation will be carried out using an on-line questionnaire distributed to an intervention and a control groups at two time periods: before starting the program (Baseline, time 0 or T0), after finishing the study - including the dissemination phase - (time 1 or T1). In addition, a process evaluation will be carried out with the intervention group.
Masking: None (open label)
Enrolment: 1,555 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03411564
Sponsor's protocol ID: 776905
Status last verified: Mar 2020
First submitted: 11 Jan 2018
Last updated: 25 Mar 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sanz-Barbero B, Ayala A, Ieracitano F, Rodriguez-Blazquez C, Bowes N, De Claire K, Mocanu V, Anton-Paduraru DT, Sanchez-SanSegundo M, Albaladejo-Blazquez N, das Neves ASA, da Silva Queiros AS, Jankowiak B, Waszynska K, Vives-Cases C. Effect of the Lights4Violence intervention on the sexism of adolescents in European countries. BMC Public Health. 2022 Mar 19;22(1):547. doi: 10.1186/s12889-022-12925-3.
PubMed 35305589
Vives-Cases C, Sanz-Barbero B, Ayala A, Perez-Martinez V, Sanchez-SanSegundo M, Jaskulska S, Antunes das Neves AS, Forjaz MJ, Pyzalski J, Bowes N, Costa D, Waszynska K, Jankowiak B, Mocanu V, Davo-Blanes MC. Dating Violence Victimization among Adolescents in Europe: Baseline Results from the Lights4Violence Project. Int J Environ Res Public Health. 2021 Feb 3;18(4):1414. doi: 10.3390/ijerph18041414.
PubMed 33546373
Vives-Cases C, Davo-Blanes MC, Ferrer-Cascales R, Sanz-Barbero B, Albaladejo-Blazquez N, Sanchez-San Segundo M, Lillo-Crespo M, Bowes N, Neves S, Mocanu V, Carausu EM, Pyzalski J, Forjaz MJ, Chmura-Rutkowska I, Vieira CP, Corradi C. Lights4Violence: a quasi-experimental educational intervention in six European countries to promote positive relationships among adolescents. BMC Public Health. 2019 Apr 8;19(1):389. doi: 10.1186/s12889-019-6726-0.
PubMed 30961558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lights, Camera and Action Against Dating Violence!
ClinicalTrials.gov ID: NCT03411564
Acronym / sponsor ID: 776905
Conditions: Violence in Adolescence
Keywords: dating violence, health promotion, educational intervention, health assets, participation action research
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,555 participants (actual)
Lead sponsor: University of AlicanteUniversity, hospital or other
Collaborators: European Commission
Study start: 1 Oct 2018 (actual)
Primary completion: 30 Jan 2019 (actual)
Study completion: 20 Jul 2019 (actual)
First posted: 26 Jan 2018 (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.

Detailed description

DESIGN: Longitudinal quasi-experimental educational intervention study with a quantitative evaluation.

Determining the competencies and capacities of the participants to carry out the on-line questionnaire.
Calculating the time it takes the students to complete the questionnaire
Carrying out an internal validation of the questionnaire (that is, are there different responses to similar questions?) among the study population by calculating internal consistency and validity indices.

The obtained results will be shared among the members of the consortium in order to evaluate possible adaptations considered necessary.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Longitudinal quasi-experimental educational intervention study. The evaluation will be carried out using an on-line questionnaire distributed to an intervention and a control groups at two time periods: before starting the program (Baseline, time 0 or T0), after finishing the study - including the dissemination phase - (time 1 or T1). In addition, a process evaluation will be carried out with the intervention group.

Arm	Type	Receives
Group 1	Experimental	Other: Filming Together to See Ourselves in a New 'Present'Students enrolled in one or two targeted secondary schools in each city who are going to receive the intervention (workshop)
Grup 0	No intervention	–Students from other centers with similar socioeconomic characteristics (relating to social characteristics and school location) to the centers.

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Boys and girls aged 13 to 17 years, studying in the targeted secondary schools in each city.

Key exclusion criteria (1 listed)

Students with language barriers

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
Filming Together to See Ourselves in a New 'Present'PHASE 0. PRIOR TRAINING 1) Promoting protective assets related to violence together. 10-hour training session with 10-15 secondary school teachers; 2) Identifying our own protective assets against violence. This training activity will be addressed to targeted students. The activity will be carried out in four sessions of 1 hour in duration. PHASE 1.PRE-PRODUCTION. 1) Participant activity on building story arguments; and 2) Construction of a technical and literary guide to the video capsules. PHASE 2: PRODUCTION.- 1) Rehearsal of the script developed by each group; 2) Preparation and selection of environment, wardrobe and characterization of the roles and, 3) Filming of the video capsules. PHASE 3: POST-PRODUCTION.- This phase consists of putting together the short film using the various video capsules. PHASE 4: DISSEMINATION. A short film exhibition to provide a space where participants can present their video capsules and briefly explain the production process.	Other	Group 1

Primary outcome

Attitudes against sexism
Time frame: 1-6 months after the intervention
The Ambivalent Sexism Inventory, a 22-item self-report measure of sexism. Respondents indicate their level of agreement, on a 6-point Likert-type scale, with various statements. It is composed of two sub-scales that may be independently calculated for sub-scale scores or may be averaged for an overall composite sexism score. The first sub-scale is the hostile sexism scale, which is composed of 11 items designed to assess an individual's position on the dimensions of dominative paternalism, competitive gender differentiation, and heterosexual hostility, as previously defined. The second sub-scale is the benevolent sexism scale, which is composed of 11 items that aim to assess an individual's position on the dimensions of protective paternalism, complementary gender differentiation, and heterosexual intimacy.
Level of Aggression
Time frame: 1-6 months after the intervention
Aggression Questionnaire-Refined measures four aspects of aggression: Physical Aggression and Verbal Aggression, which involve hurting or harming others and represent the instrumental or motor component of behavior; Hostility, which consists of feelings of ill-will and injustice and represents the cognitive component of behavior; and Anger, which involves physiological arousal and preparation for aggression and represents the emotional or affective component of behavior.
Intolerance towards intimate partner violence
Time frame: 1-6 months after the intervention
The Maudsley Violence Questionnaire measures a range of cognitions, relating to violent behavior, drawn from clinical and theoretical perspectives. This measure integrates justification of violence in response to threatened self-esteem and the legitimization of violence as central elements. Participants are asked to rate as True or False a series of statements. The scale is comprised of two factors: 'machismo' (42 items) and 'acceptance of violence' (14 items).

4 secondary outcomes

Problem Solving capacity
Time frame: 1-6 months after the intervention
Interpersonal reactivity
Time frame: 1-6 months after the intervention
Self-esteem
Time frame: 1-6 months after the intervention
Assertiveness
Time frame: 1-6 months after the intervention

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 25 Mar 2020.
Derived from this study: PubMed 35305589Sanz-Barbero B, Ayala A, Ieracitano F, Rodriguez-Blazquez C, Bowes N, De Claire K, Mocanu V, Anton-Paduraru DT, Sanchez-SanSegundo M, Albaladejo-Blazquez N, das Neves ASA, da Silva Queiros AS, Jankowiak B, Waszynska K, Vives-Cases C. Effect of the Lights4Violence intervention on the sexism of adolescents in European countries. BMC Public Health. 2022 Mar 19;22(1):547. doi: 10.1186/s12889-022-12925-3.
Derived from this study: PubMed 33546373Vives-Cases C, Sanz-Barbero B, Ayala A, Perez-Martinez V, Sanchez-SanSegundo M, Jaskulska S, Antunes das Neves AS, Forjaz MJ, Pyzalski J, Bowes N, Costa D, Waszynska K, Jankowiak B, Mocanu V, Davo-Blanes MC. Dating Violence Victimization among Adolescents in Europe: Baseline Results from the Lights4Violence Project. Int J Environ Res Public Health. 2021 Feb 3;18(4):1414. doi: 10.3390/ijerph18041414.
Derived from this study: PubMed 30961558Vives-Cases C, Davo-Blanes MC, Ferrer-Cascales R, Sanz-Barbero B, Albaladejo-Blazquez N, Sanchez-San Segundo M, Lillo-Crespo M, Bowes N, Neves S, Mocanu V, Carausu EM, Pyzalski J, Forjaz MJ, Chmura-Rutkowska I, Vieira CP, Corradi C. Lights4Violence: a quasi-experimental educational intervention in six European countries to promote positive relationships among adolescents. BMC Public Health. 2019 Apr 8;19(1):389. doi: 10.1186/s12889-019-6726-0.
Individual participant dataSharing planned: No

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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.

Carmen Vives-Cases, Dr principal investigator

University of Alicante

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Filming Together to See Ourselves in a New 'Present' in people with Violence in Adolescence, run by University of Alicante 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 1 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 25 Mar 2020. 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?

Attitudes against sexism (time frame: 1-6 months after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03411564, which also lists 3 linked publications.

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 25 Mar 2020.