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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
University of Deusto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Adolescence, Prevention, Emotional disorders, Aggressive behavior

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 20, 2018
    Last Updated
    October 1, 2018
    Sponsor
    University of Deusto
    Collaborators
    Medikosta IMQ Análisis Clínicos
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    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.

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    Intervention Based on Implicit Theories of Personality: Effects on Depression and Bullying

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