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Depressive SymptomsNCT04133389

Believing People Can Change: A Randomized Controlled Trial of an Incremental Theory Intervention in Adolescence

A study testing Growth mindset of personality educational intervention and Growth mindset of athletic ability educational intervention in people with Depressive Symptoms and Happiness, run by University of Guelph at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will test the effectiveness of a brief educational intervention that teaches youth that they can grow and change, known as "growth mindset." Similar growth mindset interventions have improved youths' well-being and academic skills, and reduced risk for depression. Read more about this study

Who is it for?
Ages 13 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Depressive Symptoms, Happiness, Life Satisfaction
What is being tested?
Growth mindset of personality educational intervention and Growth mindset of athletic ability educational intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
576 participants
Where
1 siteCanada
Study dates
15 Oct 2019to 6 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • A student at one of the recruited schools in grade 9 or 12
  • Age 13-18 years
  • Able to read and write fluently in English
  • Have parent/guardian consent, and provide participant consent

Who cannot join

  • Not a registered student at one of the recruited schools
  • Less than 13 or more than 18 years old
  • Unable to read and write fluently in English
  • Does not have parent/guardian consent or does not consent to participate

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Guelph

    Guelph, Ontario, N1G 2W1

Other trials in Canada

About this study

Official title: Believing People Can Change: An Examination of the Role of Implicit Theory, Attributional Style and Psychological Flexibility in Depression and Wellbeing, & a Randomized Controlled Trial of an Incremental Theory Intervention in Adolescence

This study will test the effectiveness of a brief educational intervention that teaches youth that they can grow and change, known as "growth mindset." Similar growth mindset interventions have improved youths' well-being and academic skills, and reduced risk for depression. In this study, youths' depressive symptoms and well-being will be measured before the intervention and then again 4 months after the intervention to determine if the intervention had a positive impact for youth experiencing transitions (firs and last years of high school).

Read the detailed description

Adolescents experience many major life transitions during high school, including changes in educational settings, living arrangements, and social and romantic relationships. While these transitions may be experienced as positive new beginnings for some youth, others experience them as stressful and challenging. Further, the developmental period of adolescence is characterized by an increased risk for the development of mental illnesses such as depression. In the context of widely-accepted cognitive models of adolescent depression, adolescents with pre-existing vulnerabilities for depression (e.g., negative self beliefs) may be more prone to experience certain life transitions as especially stressful, and this vulnerability/environment combination is likely to bring about depressive symptomatology for vulnerable youth. Thus, there is a pressing need to better understand factors that not only protect youth from mental illness during transitions, but also factors that promote resilience and well-being. Indeed, high schools are eager to address student mental illness and find better ways of promoting mental health and well-being in schools.

This project employs clinical, cognitive, developmental, and positive psychology theories in an attempt to better understand factors that may be important for adolescent mental illness and mental health during this important time of transition. Specifically, we aim to examine the utility of a brief online educational intervention for promoting adolescent mental health during important life transitions.

One important factor that appears to be associated with wellbeing and resilience is that of beliefs about growth and response to failure. Individuals often respond to challenge by either a) retreating and/or making negative attributions about themselves or others, or b) view challenge as an opportunity for learning and growth, and not consider failure to be an indication of personal shortcomings. The difference between these two responses to challenge reflects beliefs about the malleability of personal characteristics; these beliefs are referred to as "implicit theories" or more colloquially "mindset". Those who hold "entity" theories (fixed mindset) believe personal characteristics are stable and unchanging, while those with a malleable or "incremental theories" (growth mindset) believe personal characteristics are changeable and can be developed through effort and learning . Research has broadly suggested that those with entity theories may be more prone to experience difficulties and be at risk for mental illness, while those with incremental theories experience greater resilience and well-being.

Previous research has indicated that incremental theory can be taught via educational interventions, and increasing belief in incremental theory has been associated with positive effects. Further, integrating positive psychology into educational institutions to foster youth development has been recommended by many researchers. Youth spend substantial amounts of time in school, making schools an appropriate setting for interventions that aim to promote well-being and prevent mental illness. Thus, this study will test the effects of a brief implicit theory intervention on well-being and depressive symptoms.The intervention is similar to previous implicit theory interventions and teaches youth an incremental theory of socially relevant characteristics (i.e., that people can change and that personal attributes are malleable).

Implicit theory of personality (ie, beliefs about the malleability of personal attributes and socially relevant characteristics) has also been associated with depressive symptoms in youth. In a study of grade 9 students, researchers found that a brief intervention that taught incremental theory of personality (that personal attributes can grow and change) was associated with stability of reported levels of depressive symptoms over 9 months. In this intervention, students read a compelling article that demonstrated incremental theory of either personality (experimental) or athletic ability (control), then students were asked to summarize the lesson of the article and apply their own experience. Over time (9 months) those in the control condition showed an increase in depressive symptoms while those exposed to the incremental theory of personality did not show the same increase, and incidence of clinically significant depressive symptoms remained stable. The increase seen in the control group was noted to be proportional to that commonly experienced by those transitioning to high school, suggesting the intervention may have promise for successfully ameliorating developmentally typical increases in depressive symptoms. Although this brief intervention was associated with significant positive outcomes, replication and application to other samples at risk for depressive symptoms (such as youth transitioning out of high school and to post secondary education) is warranted. Towards this end, the current study will examine the impact of an intervention that teaches incremental theory on well-being and depressive symptoms in students in the first and last years of high school.

Being tested
Growth mindset of personality educational intervention, Growth mindset of athletic ability educational intervention
Keywords
Growth mindset, Implicit theory, Adolescence, Mental Health, Well-being, students, Secondary Schools, Educational intervention
Medical subject headings
Depression, Personal Satisfaction, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Growth mindset of personality educational interventionOther

    This is a brief online educational intervention that teaches growth mindset of personality. The intervention includes pictures, text, videos, and questions administered through Qualtrics survey software.

  • Growth mindset of athletic ability educational interventionOther

    This is a brief online educational intervention that teaches growth mindset of athletic ability. The intervention includes pictures, text, videos, and questions administered through Qualtrics survey software.

Study groups in NCT04133389
Study groupRoleWhat they receive
Growth Mindset of PersonalityExperimentalExperimental intervention
Receives: Other: Growth mindset of personality educational intervention
Growth Mindset of Athletic AbilityPlacebo comparatorControl intervention
Receives: Other: Growth mindset of athletic ability educational intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depressive symptoms

    Score on the Beck Depression Inventory-II. The BDI-II consists of 21 items using a 4-point Likert scale from 0 to 3, however the current study will use only 19 items. The item querying suicidal ideation will be removed, as this may be triggering, and researchers would not be able to follow up with those who would highly endorse this item. The item querying sexual interest will be removed, as this may not be equally applicable across the sample. Scores on each item are summed to determine summary scores from 0-57. Higher scores indicate higher levels of depressive symptoms.

    Measured: 4 months (Oct 2019 - Feb 2020)

  2. Perceived happiness

    score on the Subjective Happiness Scale (SHS). This measure consists of four items measured on a 7-point Likert scale; responses are averaged to create a summary score (minimum=1, maximum=7) and higher scores reflect higher levels of subjective happiness.

    Measured: 4 months (Oct 2019 - Feb 2020)

  3. Life satisfaction

    score on the Brief Multidimensional Student Life Satisfaction Scale (BMSLSS). The BMSLSS includes five items that assess global life satisfaction as a reflection of five life domains: family, school, friends, self, and living environment. The BMSLSS uses a 7-point Likert scale that ranges from delighted to terrible. The score of each item will be averaged to create a single score (minimum=1, maximum=7) such that higher scores represent higher levels of life satisfaction.

    Measured: 4 months (Oct 2019 - Feb 2020)

Secondary outcomes (4)
  1. Implicit theory of personality

    Score on the Implicit Personality Theory Questionnaire. This is a three-item measure that uses a 6-point Likert scale that ranges from strongly agree to strongly disagree to measure the extent individuals believe one's personality can change. The score of each item will be averaged to create a single score (minimum=1, maximum=6) such that higher values will be associated with higher levels of entity beliefs.

    Measured: immediately post administration of the intervention

  2. Implicit theory of a person (general)

    Score on the Implicit Person Measure. This is a three item measure with a 6-point Likert scale ranging from strongly agree to strongly disagree. Scores on each item will be averaged to create a single score (minimum=1, maximum=6), and higher average scores will be associated with more entity beliefs.

    Measured: Immediately post administration of the intervention

  3. Implicit theory of personality

    Score on the Implicit Personality Theory Questionnaire. This is a three-item measure that uses a 6-point Likert scale that ranges from strongly agree to strongly disagree to measure the extent individuals believe one's personality can change. The score of each item will be averaged to create a single score (minimum=1, maximum=6) such that higher values will be associated with higher levels of entity beliefs.

    Measured: 4 months (Oct 2019 - Feb 2020)

  4. Implicit theory of a person (general)

    Score on the Implicit Person Measure. This is a three item measure with a 6-point Likert scale ranging from strongly agree to strongly disagree. Scores on each item will be averaged to create a single score (minimum=1, maximum=6), and higher average scores will be associated with more entity beliefs.

    Measured: 4 months (Oct 2019 - Feb 2020)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start15 Oct 2019
  3. Primary completion6 Mar 2020
  4. Study completion6 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The current study is a two-wave randomized controlled trial that employs a 2 (group - between participants) by 2 (time - within participants) mixed measures design to assess a brief online implicit theory of personality intervention.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
576 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133389
Sponsor's protocol ID
19-03-019
Status last verified
Apr 2020
First submitted
17 Oct 2019
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share individual participant data as this has not been approved by our Research Ethics Board

Publications

  • Abela, J. R. Z., & Hankin, B. L. (2008). Depression in children and adolescents: Causes, treatment, and prevention. In J. R. Z. Abela & B. L. Hankin (Eds.), Handbook of depression in children and adolescents (pp. 3-5). New York, NY, US: The Guilford Press.

  • Abramson, L. Y., Metalsky, G. I., & Alloy, L. B. (1989). Hopelessness depression: A theory-based subtype of depression. Psychological review, 96(2), 358.

  • Abramson LY, Seligman ME, Teasdale JD. Learned helplessness in humans: critique and reformulation. J Abnorm Psychol. 1978 Feb;87(1):49-74. No abstract available.

    PubMed 649856
  • Dweck, C. S., Chiu, C. Y., & Hong, Y. Y. (1995). Implicit theories and their role in judgments and reactions: A word from two perspectives. Psychological inquiry, 6(4), 267-285.

  • Dweck, C. S., & Leggett, E. L. (1988). A social-cognitive approach to motivation and personality. Psychological review, 95(2), 256.

  • Furlong, M. J., Gilman, R., & Huebner, E. S. (2014). Handbook of Positive Psychology in Schools, 2nd Ed New York. NY: Taylor & Francis.

  • Greenberg MT, Weissberg RP, O'Brien MU, Zins JE, Fredericks L, Resnik H, Elias MJ. Enhancing school-based prevention and youth development through coordinated social, emotional, and academic learning. Am Psychol. 2003 Jun-Jul;58(6-7):466-74. doi: 10.1037/0003-066x.58.6-7.466.

    PubMed 12971193
  • Hankin BL, Abramson LY, Moffitt TE, Silva PA, McGee R, Angell KE. Development of depression from preadolescence to young adulthood: emerging gender differences in a 10-year longitudinal study. J Abnorm Psychol. 1998 Feb;107(1):128-40. doi: 10.1037//0021-843x.107.1.128.

    PubMed 9505045
  • Hong, Y. Y., Chiu, C. Y., Dweck, C. S., Lin, D. M. S., & Wan, W. (1999). Implicit theories, attributions, and coping: A meaning system approach. Journal of Personality and Social psychology, 77(3), 588.

  • Masten, A., Herbers, J., Cutuli, J., & Lafavor, T. (2008). Promoting competence and resilience in the school context. Professional School Counseling, 12(2), 76-84.

  • Merikangas KR, He JP, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9. doi: 10.1016/j.jaac.2010.05.017. Epub 2010 Jul 31.

    PubMed 20855043
  • Petersen AC, Compas BE, Brooks-Gunn J, Stemmler M, Ey S, Grant KE. Depression in adolescence. Am Psychol. 1993 Feb;48(2):155-68. doi: 10.1037//0003-066x.48.2.155.

    PubMed 8442570
  • Rindfuss RR. The young adult years: diversity, structural change, and fertility. Demography. 1991 Nov;28(4):493-512. No abstract available.

    PubMed 1769399
  • Seligman, M. E., Ernst, R. M., Gillham, J., Reivich, K., & Linkins, M. (2009). Positive education: Positive psychology and classroom interventions. Oxford review of education, 35(3), 293-311.

  • Yeager, D. S., & Dweck, C. S. (2012). Mindsets that promote resilience: When students believe that personal characteristics can be developed. Educational psychologist, 47(4), 302-314.

Questions about this trial

What is this clinical trial studying?

A study testing Growth mindset of personality educational intervention and Growth mindset of athletic ability educational intervention in people with Depressive Symptoms and Happiness, run by University of Guelph at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive symptoms (time frame: 4 months (Oct 2019 - Feb 2020)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04133389, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

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