Intervention Based on Implicit Theories of Personality: Effects on Depression and Bullying (ITP)
Primary Purpose
Depression, Bullying
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Incremental theory of personality
Educational Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Adolescence, Prevention, Emotional disorders, Aggressive behavior
Eligibility Criteria
Inclusion Criteria:
- Informed consent by the adolescents and their parents.
- To be fluent in Spanish.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Incremental theory of personality
Educational intervention
Arm Description
1 hour behavioral intervention (based on ITP) consisting on several tasks to be completed on paper individually.
1 hour educational intervention (about the human brain) consisting on several tasks to be completed on paper individually.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03481699
First Posted
March 20, 2018
Last Updated
October 1, 2018
Sponsor
University of Deusto
Collaborators
Medikosta IMQ Análisis Clínicos
1. Study Identification
Unique Protocol Identification Number
NCT03481699
Brief Title
Intervention Based on Implicit Theories of Personality: Effects on Depression and Bullying
Acronym
ITP
Official Title
Prevention of Depression and Bullying in Adolescents by Means of an Intervention Based on Implicit Theories of Personality
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Deusto
Collaborators
Medikosta IMQ Análisis Clínicos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Depression and bullying are two problems arising in childhood and adolescence, which cause severe suffering. Although there are good intervention programs for children and adolescents at risk, the results for universal interventions have generally been poor. The current project will test the efficacy of an Intervention based on the Implicit Theories of Personality (ITP). This procedure has recently been developed at US by David S. Yeager and colleagues, with extraordinary results in the reduction of depression, stress, and aggression. The project includes the following aims: (1) the evaluation of the efficacy of the ITP on depressive symptoms (Study 1) and aggressive behavior (Study 2) in Spanish adolescents; (2) to test whether the intervention changes biological and cognitive variables; (3) to identify whether development and sex moderates the effects of the intervention; and (4) to test whether temperament moderates the effect of the intervention. The study involves the evaluation of the intervention in a sample of around 900 adolescents (12-18 years), randomly allocated to experimental and control condition. It is a field experiment conducted in high schools and involves multiple measures over time (self-reports and parent reports; as well as levels of cortisol, testosterone and DHEA in saliva in a subset -50%- of the participants). 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 depression and bullying.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bullying
Keywords
Adolescence, Prevention, Emotional disorders, Aggressive behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Allocation was concealed to the participants, researchers -who were in class the assessment days- and teachers.
Allocation
Randomized
Enrollment
882 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Incremental theory of personality
Arm Type
Experimental
Arm Description
1 hour behavioral intervention (based on ITP) consisting on several tasks to be completed on paper individually.
Arm Title
Educational intervention
Arm Type
Other
Arm Description
1 hour educational intervention (about the human brain) consisting on several tasks to be completed on paper individually.
Intervention Type
Behavioral
Intervention Name(s)
Incremental theory of personality
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline scores of the Center for Epidemiologic Studies Depression scale (CES-D; Radloff, 1977) at 2 weeks, 6 months, and 12 months.
Description
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.
Time Frame
Baseline, 2 weeks, 6 months, and 12 months.
Title
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.
Description
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.
Time Frame
Baseline, 2 weeks, 6 months, and 12 months.
Title
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.
Description
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.
Time Frame
Baseline, 2 weeks, 6 months, and 12 months.
Title
Change from baseline levels of Cortisol, DHEA and testosterone (in saliva) at 2 weeks, 6 months, and 12 months.
Description
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.
Time Frame
Baseline, 2 weeks, 6 months, and 12 months.
Other Pre-specified Outcome Measures:
Title
Implicit Theories of Personality questionnaire (Yeager et al., 2014)
Description
Self reported measure that assesses adolescents' implicit theories of personality during the last 6 months (last week in the 1 week follow-up) measured by 8 items scored 1-6 (1 = strongly disagree; 6 = strongly agree), yielding a total between 8 and 48.
Time Frame
Baseline, 2 weeks, 6 months, and 12 months.
Title
Young Schema Questionnaire (YSQ-3; Young, 2006)
Description
Self reported maladaptive cognitive schemas during the last 6 months (last week in the 1 week follow-up). The original version has 90 items, but for the purposes of this study, we have included 35 items of 7 subscales: defectiveness/shame (5 items), mistrust/abuse (5 items), entitlement superiority/grandiosity (5 items), failure to achieve (5 items), insufficient self control/self discipline (5 items), abandonment/instability (5 items), emotional deprivation (deprivación). Each item is scored 1-6 (1 = strongly disagree; 6 = strongly agree), yielding a total between 5 and 30 for each subscale.
Time Frame
Baseline, 2 weeks, 6 months, and 12 months.
Title
Big Five Questionnaire for children (BFQ-C; Barbaranelli et al., 2003)
Description
Self reported questionnaire that assesses five personality traits: openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism. For the purpose of this study, we have used the 21 items from the extraversion and neuroticism subscales. Each item is scored 1-5 (1 =almost always untrue of you ; 5 = almost always true of you).
Time Frame
Baseline.
Title
Revised version of the Early Adolescent Temperament Questionnaire (EATQ-R; Ellis and Rothbart, 2001).
Description
Self reported questionnaire of that assesses temperament in adolescents. For this study, only the 10 items of the temperament domain of effortful control were used, which measure self-regulation aspects of temperament in adolescents with three subscales: inhibition control, attention and activation control. Each item is scored 1-5 (1 =almost always untrue of you ; 5 = almost always true of you), yielding a total between 1 and 50.
Time Frame
Baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Informed consent by the adolescents and their parents.
To be fluent in Spanish.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Calvete, PhD
Organizational Affiliation
University of Deusto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
Intervention Based on Implicit Theories of Personality: Effects on Depression and Bullying
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