NCT03481699

Brief Summary

This study evaluates the efficacy of an intervention based on the Implicit Theories of Personality (ITP) in Spanish adolescents. Half of participants received the ITP intervention, while the other half received an educational intervention.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
882

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Oct 2016

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

Study Start

First participant enrolled

October 3, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

March 20, 2018

Last Update Submit

October 1, 2018

Conditions

Keywords

AdolescencePreventionEmotional disordersAggressive behavior

Outcome Measures

Primary Outcomes (4)

  • Change from baseline scores of the Center for Epidemiologic Studies Depression scale (CES-D; Radloff, 1977) at 2 weeks, 6 months, and 12 months.

    Self reported depressive symptoms during the last month (last week in the 1 week follow-up) measured by 20 items scored 0-3 (0 = rarely; 3 = most or almost all the time), yielding a total between 0 and 60.

    Baseline, 2 weeks, 6 months, and 12 months.

  • Change from baseline scores of the Revised version of the Peer Experiences Questionnaire (RPEQ; Prinstein, Boergers, & Vernberg, 2001) at 2 weeks, 6 months, and 12 months.

    Self reported levels of perpetration (9 items) of peer aggression in the school context during the last 6 months (last week in the 1 week follow-up). Each item is scored 1-5 (1 = never; 5 = several times per week), yielding a total between 18 and 90.

    Baseline, 2 weeks, 6 months, and 12 months.

  • Change from baseline scores of the Cyber Bullying Questionnaire (CBQ; Calvete et al., 2012; Gámez-Guadix, Villa-George, & Calvete, 2014) at 2 weeks, 6 months, and 12 months.

    Self reported levels of perpetration (9 items) of peer cyber aggression during the last 6 months (last week in the 1 week follow-up). Each item is scored 0-3 (0 = never; 3 = five or more times), yielding a total between 0 and 54.

    Baseline, 2 weeks, 6 months, and 12 months.

  • Change from baseline levels of Cortisol, DHEA and testosterone (in saliva) at 2 weeks, 6 months, and 12 months.

    A random subset of the participants (n = 546) have provided saliva samples to be assayed for neuroendocrine levels to measure cortisol, DHEA and testosterone. They were directed to transfer saliva from their mouths to a tube. The sample tubes were carefully labelled, and as soon as the session ended, saliva samples were sent to the assay laboratory (Medikosta IMQ Análisis Clínicos) and stored in a freezer at -80°C.

    Baseline, 2 weeks, 6 months, and 12 months.

Other Outcomes (4)

  • Implicit Theories of Personality questionnaire (Yeager et al., 2014)

    Baseline, 2 weeks, 6 months, and 12 months.

  • Young Schema Questionnaire (YSQ-3; Young, 2006)

    Baseline, 2 weeks, 6 months, and 12 months.

  • Big Five Questionnaire for children (BFQ-C; Barbaranelli et al., 2003)

    Baseline.

  • +1 more other outcomes

Study Arms (2)

Incremental theory of personality

EXPERIMENTAL

1 hour behavioral intervention (based on ITP) consisting on several tasks to be completed on paper individually.

Behavioral: Incremental theory of personality

Educational intervention

OTHER

1 hour educational intervention (about the human brain) consisting on several tasks to be completed on paper individually.

Other: Educational Intervention

Interventions

The experimental intervention (originally developed by David S. Yeager and colleagues) teaches that individuals have the potential to change. It has three main parts. First, participants are asked to read scientific studies that provide evidence that behaviors are controlled by "thoughts and feelings in brains," and that pathways in the brain have the potential to be changed under the right circumstances. Second, participants read several testimonials purportedly written by upperclassmen to bring credibility to the ITP. Finally, participants are asked to write their own version of such a narrative. This self-persuasive writing exercise has been shown to facilitate the internalization of the intervention message, building on a long line of research on cognitive dissonance.

Incremental theory of personality

The educational intervention involved scientific information about the human brain. It was designed to be parallel to the experimental intervention and, hence, it has also three main parts. First, participants are asked to read scientific information about the different areas of the brain and their specialties. Second, participants read several testimonials written by upperclassmen about their transition to high school and how their brains help them to adapt to the new space and all the physical differences of the building and the classes. Finally, participants are asked to write a letter to another student explaining the main things he or she has learned about the brain and thinks are important for adapting to the new physical environment in high school.

Educational intervention

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Informed consent by the adolescents and their parents.
  • To be fluent in Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionBullyingAggression

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorHarassment, Non-SexualSocial BehaviorAberrant Motor Behavior in Dementia

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

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 was concealed to the participants, researchers -who were in class the assessment days- and teachers.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomized in a 1:1 ratio blocked by gender to one of two groups: experimental condition (ITP intervention) versus control condition (educational intervention) 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

March 20, 2018

First Posted

March 29, 2018

Study Start

October 3, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

October 3, 2018

Record last verified: 2018-10