Clinical trial NCT03481699: Intervention Based on Implicit Theories of Personality: Effects on Depression and Bullying
Official title: Prevention of Depression and Bullying in Adolescents by Means of an Intervention Based on Implicit Theories of Personality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Bullying
Keywords: Adolescence
Prevention
Emotional disorders
Aggressive behavior
Lead sponsor: University of Deusto
Sponsor class: OTHER
Collaborators: name: Medikosta IMQ Análisis Clínicos
First posted: 2018-03-29
Enrollment: 882
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Informed consent by the adolescents and their parents.
* To be fluent in Spanish.

Primary outcomes:
measure: Change from baseline scores of the Center for Epidemiologic Studies Depression scale (CES-D; Radloff, 1977) at 2 weeks, 6 months, and 12 months.
timeFrame: Baseline, 2 weeks, 6 months, and 12 months.
measure: 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.
timeFrame: Baseline, 2 weeks, 6 months, and 12 months.
measure: 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.
timeFrame: Baseline, 2 weeks, 6 months, and 12 months.
measure: Change from baseline levels of Cortisol, DHEA and testosterone (in saliva) at 2 weeks, 6 months, and 12 months.
timeFrame: Baseline, 2 weeks, 6 months, and 12 months.
Secondary outcomes:
Other outcomes:
measure: Implicit Theories of Personality questionnaire (Yeager et al., 2014)
timeFrame: Baseline, 2 weeks, 6 months, and 12 months.
measure: Young Schema Questionnaire (YSQ-3; Young, 2006)
timeFrame: Baseline, 2 weeks, 6 months, and 12 months.
measure: Big Five Questionnaire for children (BFQ-C; Barbaranelli et al., 2003)
timeFrame: Baseline.
measure: Revised version of the Early Adolescent Temperament Questionnaire (EATQ-R; Ellis and Rothbart, 2001).
timeFrame: Baseline.
Locations:
Study officials:
affiliation: University of Deusto
name: Esther Calvete, PhD
role: PRINCIPAL_INVESTIGATOR
References: