NCT07212283

Brief Summary

This study evaluates the effectiveness of a wise Intervention to reduce aggressive behaviors and promote prosocial behaviors toward LGB-TNB individuals among Spanish adolescents. Half of the participants will receive the experimental intervention, while the other half will receive a control intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Sep 2025Jun 2026

Study Start

First participant enrolled

September 18, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

September 30, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

AdolescenceLGBTQAggressionProsocial BehaviorWise Intervention

Outcome Measures

Primary Outcomes (4)

  • Change from baseline in aggression scores toward LGB-TNB individuals, assessed using an adaptation of the Spanish version (Orue et al., 2018) of the Homophobic Bullying Scale (Prati, 2012).

    It consists of seven items that ask frequency with wich participants have engaged in specific aggressive behavior toward LGB-TNB individuals. Five response categories are provided using a Likert-type response scale, ranging from 1 (never) to 5 (daily).

    Assessments were conducted at baseline and at 3, 6, and 9 months.

  • Change from baseline in online aggression scores toward LGB-TNB individuals, assessed using the Technology-Facilitated Gender- and Sexuality-Based violence (TFGSV; Martínez-Bacaicoa et al., 2023).

    It consists of eight items that ask frequency with wich participants have engaged in online aggressive behavior toward LGB-TNB individuals. Five response categories are provided using a Likert-type response scale, ranging from 1 (never) to 5 (daily).

    Assessments were conducted at baseline and at 3, 6, and 9 months.

  • Change from baseline in prosocial behavior scores toward LGB-TNB individuals through an ad hoc measure.

    It consists of one item in which participants were asked to select all the behaviors they engaged in after witnessing an aggression.

    Assessments were conducted at baseline and at 3, 6, and 9 months.

  • Change from baseline in bystander intention scores when witnessing aggressive behavior toward LGB-TNB individuals.

    This measure evaluate bystander intentions in response to LGB-TNB aggressions, through different scenarios. After reading the scenarios, participants answered five items that evaluated possible courses of action to take in response to the aggression.

    Assessments were conducted at baseline, immediately after the intervention, and at 3, 6, and 9 months.

Secondary Outcomes (8)

  • Change from baseline in moral disengagement scores, assessed using the mechanisms of moral disengagement described by Bandura (2016) and based on studies with similar characteristics (Martínez-Bacaicoa et al., 2024).

    Assessments were conducted at baseline and at 3, 6, and 9 months.

  • Change from baseline in justice sensitivity scores, assessed using the Justice Sensitivity Inventory (Schmitt et al., 2010).

    Assessments were conducted at baseline and at 3, 6, and 9 months.

  • Change from baseline in behaviors supporting LGB-TNB individuals, assessed using the LGBT-Affirming Behavior questionnaire (Poteat, 2015).

    Assessments were conducted at baseline and at 3, 6, and 9 months.

  • Change from baseline in microaggression scores toward LGB-TNB individuals, assessed using the Sexual Orientation Microaggression Scale (SOMS-P; Botor & Tuliao, 2025) and the Gender Identity Microaggression Scale (GIMS-P; Botor & Tuliao, 2025).

    Assessments were conducted at baseline and at 3, 6, and 9 months.

  • Change from baseline in offline perpetration scores, assessed using the Spanish adaptation (Ortega-Ruiz et al., 2016) of the European Bullying Intervention Project Questionnaire (Brighi et al., 2012).

    Assessments were conducted at baseline and at 3, 6, and 9 months.

  • +3 more secondary outcomes

Study Arms (2)

Values alignment wise intervention

ACTIVE COMPARATOR
Behavioral: Values alignment wise intervention

Wise Intervention LGB-TNB

EXPERIMENTAL
Behavioral: Wise Intervention LGB-TNB

Interventions

The intervention will be designed to reduce aggressive behaviors based on sexual orientation and gender identity and to promote prosocial behaviors toward these individuals. This intervention will include three components: (1) reading scientific studies about people's ability to change. In addition, they will read other studies about how thoughts and emotions influence behavior through brain pathways, and that these pathways can be modified under certain circumstances; (2) reading testimonials that support the idea that people can change. These testimonials include accounts of people who were victims or perpetrators based on sexual orientation and gender identity, including important components of empathy and prosocial behaviors toward the victims. To give credibility to the intervention, they will be informed that these stories were written by other young people who previously participated; and (3) self-persuasion exercises that involve an active commitment to change.

Wise Intervention LGB-TNB

This intervention will be based on the same strategies as the experimental intervention, but it will not address aspects related to prosocial behaviors or aggression toward LGB-TNB individuals; instead, it will be applied to improve adolescents' eating habits.

Values alignment wise intervention

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Informed consent by the adolescents and their families.
  • To be fluent in Spanish and/or Euskera.

You may not qualify if:

  • Lack of permission by families and the adolescent.
  • Lack of understanding of the instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nerea

Bilbao, BIZKAIA, 48007, Spain

RECRUITING

MeSH Terms

Conditions

AggressionAltruism

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Central Study Contacts

Nerea Cortazar Enciondo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Allocation will be concealed to the participants and teachers. Assessment will be done online through self-reports.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized controlled trial with two groups will be used. Randomization will be done by clusters, using the classroom as the unit. First, the schools will be selected according to their characteristics. Then, half of the participants will be assigned to the experimental intervention (condition 1) and the other half to the control intervention (condition 2) in parallel for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 8, 2025

Study Start

September 18, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Raw data will be available at OSF when the results of the study are published.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.
Access Criteria
Public

Locations