NCT03583645

Brief Summary

This study evaluates the efficacy of an intervention based on the Implicit Theories of Personality (ITP) to prevent dating violence 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
402

participants targeted

Target at P75+ for not_applicable

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
4 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

June 28, 2018

Last Update Submit

November 7, 2018

Conditions

Keywords

AdolescencePreventionAggressive behaviorDating Violence

Outcome Measures

Primary Outcomes (1)

  • Change from baseline scores of the Dating Violence Questionaire (developed by the research team) at 2 weeks, 6 months, and 12 months.

    Self reported dating aggressive behaviors during the last 6 months (last week in the 1 week follow-up) measured by 25 items scored 0-3 (0 = never; 3 = often), yielding a total between 0 and 75.

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

Other Outcomes (1)

  • Affection and Communication subscale of the Parenting Style Scale (Oliva, Parra, Sanchez-Queija, & López, 2007) for parents.

    Baseline and 6 months.

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

Age13 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

Aggression

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

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

June 28, 2018

First Posted

July 11, 2018

Study Start

October 3, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 9, 2018

Record last verified: 2018-11