- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03583645
The Effect of an Intervention Based on Implicit Theories of Personality on the Prevention of Adolescent Dating Violence
November 7, 2018 updated by: Esther Calvete, University of Deusto
Prevention of Aggressive Behavior in Adolescents by Means of an Intervention Based on Implicit Theories of Personality
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
402
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed consent by the adolescents and their parents.
- To be fluent in Spanish.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Incremental theory of personality
1 hour behavioral intervention (based on ITP) consisting on several tasks to be completed on paper individually.
|
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
1 hour educational intervention (about the human brain) consisting on several tasks to be completed on paper individually.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline scores of the Dating Violence Questionaire (developed by the research team) at 2 weeks, 6 months, and 12 months.
Time Frame: Baseline, 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Affection and Communication subscale of the Parenting Style Scale (Oliva, Parra, Sanchez-Queija, & López, 2007) for parents.
Time Frame: Baseline and 6 months.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Esther Calvete, PhD, University of Deusto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 3, 2016
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
June 28, 2018
First Submitted That Met QC Criteria
June 28, 2018
First Posted (Actual)
July 11, 2018
Study Record Updates
Last Update Posted (Actual)
November 9, 2018
Last Update Submitted That Met QC Criteria
November 7, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- PI_2016_1_0023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Individual participant data will be provided to the journals in which it is planned to publish the results of the study.
In addition, the PI and research team will consider to make IPD available to other researchers after publishing the results of the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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