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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03583645
Other study ID # PI_2016_1_0023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2016
Est. completion date March 2018

Study information

Verified date November 2018
Source University of Deusto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Intimate partner violence is a problem arising in adolescence, which causes severe suffering. Since the first romantic relationships are established during adolescence, implementation of preventive interventions during this developmental stage opens a window of opportunity for the prevention of partner aggression. Previous prevention programs have shown efficacy in modifying cognitions and attitudes related to dating violence, although behavioral changes have been reported in very few cases. Recent innovative brief interventions based on changing entity theories of personality (i.e., the belief that people cannot change and personal characteristics are fixed; Miu & Yeager, 2015) have provided good results for preventing depression and other behavioral problems in adolescents. Therefore, the principal aim of this study is to examine whether a brief one-hour intervention based on promoting the idea that people can change shows efficacy in the prevention of perpetration and victimization of dating aggressive behaviors (both online -cyber dating abuse- and traditional -face-to-face dating aggression-) in adolescents. Additionally, other objective of the project is to examine whether gender moderates the effects of the intervention in changes in dating violence. The study involves the evaluation of the intervention in a sample of around 400 adolescents (13-18 years), randomly allocated to experimental and control conditions. It is a field experiment conducted in high schools and involves multiple measures over time (self-reports and parent reports). In summary, the project aims to respond to the challenge of health and wellness in the population through a randomized controlled trial with multiple sources of measure and from a biopsychosocial perspective. The ITP intervention has the potential to become a universal intervention to help reduce the rates of adolescent dating violence.


Recruitment information / eligibility

Status Completed
Enrollment 402
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

- Informed consent by the adolescents and their parents.

- To be fluent in Spanish.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Incremental theory of personality
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.
Other:
Educational Intervention
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Deusto Medikosta IMQ Análisis Clínicos

Outcome

Type Measure Description Time frame Safety issue
Other Affection and Communication subscale of the Parenting Style Scale (Oliva, Parra, Sanchez-Queija, & López, 2007) for parents. 8 items reported by the adolescents' parents from the affection and communication subscale, which assesses support and care delivered by the parents, their ability to be there, and the communication between them. Each item is scored 1-6 (1= not at all true to 6=completely true), yielding a total between 8 and 48. Baseline and 6 months.
Primary 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.
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