NCT04509531

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 30, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

July 30, 2020

Last Update Submit

September 27, 2021

Conditions

Keywords

AdolescencePreventionCyberbullyingDepressionNon Suicidal Self InjurySocial AnxietyEating Disorders

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (5)

  • Change from baseline scores of Entity and incremental theories (Levy, Stroessner, & Dweck, 1998).

    Baseline, 1 hour, 3 months, and 6 months.

  • Change from baseline scores of attitude towards cyberbullying measure

    Baseline, 1 hour, 3 months, and 6 months.

  • Change from baseline scores of attitude towards different courses of action measure

    Baseline, 1 hour, 3 months, and 6 months.

  • Change from baseline scores of the anticipation of reactions and behaviors measure

    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

    Baseline, 1 hour, 3 months, and 6 months.

Study Arms (2)

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.

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.

Behavioral: Standard preventive intervention

Interventions

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.

Experimental: SA, ITP and Resilience

The control intervention will involve scientific information and education about internet risks such as sexting and grooming.

Standard preventive intervention

Eligibility Criteria

Age11 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Spanish or Basque understanding
  • Permission by parents
  • Voluntarity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Deusto

Bilbao, Bizkaia, 48080, Spain

Location

MeSH Terms

Conditions

CyberbullyingDepressionSelf-Injurious BehaviorFeeding and Eating Disorders

Interventions

Inosine Triphosphate

Condition Hierarchy (Ancestors)

BullyingAggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial BehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Inosine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Esther Calvete, PhD

    University of Deusto

    PRINCIPAL INVESTIGATOR

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, researchers -who will be in class the assessment days if possible depending on the Covid-19 scenario- and teachers.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Deusto Stress Research Team, University of Deusto

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 12, 2020

Study Start

September 15, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

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