Condition or disease | Intervention/treatment | Phase |
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Emotions | Behavioral: Growth Mindset Behavioral: Control | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Effect of Emotion Mindsets on Emotion Processing: A Multilevel Experimental Investigation |
Actual Study Start Date : | August 27, 2018 |
Estimated Primary Completion Date : | December 15, 2021 |
Estimated Study Completion Date : | April 15, 2022 |
Arm | Intervention/treatment |
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Experimental: Growth Mindset
Persuasive education about emotions, brain development, and teenagers' ability to learn how to manage emotions
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Behavioral: Growth Mindset
Growth emotion mindset induction
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Active Comparator: Brain Education
Neutral education about functions of different parts of the brain
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Behavioral: Control
Brain education
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Ages Eligible for Study: | 13 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Identify as female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
University of Illinois | |
Champaign, Illinois, United States, 61820 |
Principal Investigator: | Karen D Rudolph, PhD | University of Illinois, Urbana Champaign |
Tracking Information | |||||||
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First Submitted Date ICMJE | June 5, 2019 | ||||||
First Posted Date ICMJE | June 7, 2019 | ||||||
Last Update Posted Date | May 24, 2021 | ||||||
Actual Study Start Date ICMJE | August 27, 2018 | ||||||
Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Effect of Emotion Mindsets on Emotion Processing | ||||||
Official Title ICMJE | Effect of Emotion Mindsets on Emotion Processing: A Multilevel Experimental Investigation | ||||||
Brief Summary | The guiding scientific premise for this research is that a growth emotion mindset will promote more adaptive emotion processing than a fixed emotion mindset. Because emotional sensitivity is particularly salient in adolescent girls, we will focus on this group. Using an experimental design, adolescent girls will be randomly assigned to either a mindset manipulation or a control group (brain education). Each group will complete a 25-minute computer-based lesson followed by a social stressor and a functional magnetic resonance imaging session. Two specific aims will be addressed: (1) to determine whether a growth mindset induction, relative to a control condition, predicts more adaptive emotion processing at the neural, behavioral, and psychological levels of processing; and (2) to determine whether neural processing of emotion accounts for the effect of a growth emotion mindset manipulation on behavioral and psychological processing of emotion. This study builds on a strong empirical database establishing the effect of mindsets on multiple domains of functioning but will be the first to examine the implications of a growth vs. fixed mindset about emotion for emotion processing in adolescent girls, thereby elucidating one specific youth attribute that can support or disrupt emotional development. | ||||||
Detailed Description |
150 adolescent girls will complete baseline measures and then be randomly assigned to one of two conditions and will complete a computer-based lesson (see below). Girls will then engage in a social stressor outside of the scanner as well as an emotional challenge and cognitive control task in the scanner and will complete post-scan measures. Two and four months after the scan session they will complete additional survey measures. Experimental condition: The GEM manipulation, involves 6 components: (1) Introduction: discussion of emotional experiences in teenagers; (2) Explanation of neuroplasticity, emphasizing the potential for changes in the brain and modification of emotions during adolescence; (3) Scientific evidence for the effect of emotion regulation training on mood improvement; (4) Brief factual quizzes and written summary of key points; (5) Scenarios in which older youth describe challenging situations when they used growth mindsets to help regulate negative emotions; and (6) Self-persuasion exercise: a. Girls read a hypothetical scenario about an emotional challenge and describe their likely thoughts and feelings; b. Girls imagine the same event happening to another (younger) teen and help them understand how they can change, integrating what they learned about malleability of the brain and emotion. Control condition: The control condition involves a structurally similar session, with the same number and type of reading and writing activities, that focuses on general education about the brain. Social stressor. Using an adapted version of the Trier Social Stressor Test, girls will prepare a speech in which they convince a group of peers (who ostensibly will watch a video of the speech; in reality, there are no peers) that they should be selected for a fictional TV show about teens' ability to form friendships. Girls face a computer screen displaying their image while preparing and presenting a speech. At intervals of 20 seconds, a female evaluator will mark a clipboard. Before and after the Trier, girls will rate several dimensions of state negative affect. After the Trier, girls will rate their use of in vivo emotion regulation strategies. Girls will then undergo scanner training and watch a neutral video during an anatomical scan. Emotional challenge (Social Evaluation Task). Girls will watch validated videos created for functional magnetic resonance imaging, which depict females making one of three types of statements with matching affective expression: negative social-evaluative, positive social-evaluative, or neutral. Before each video, girls will receive a prompt instructing them to imagine how they would feel if the female were a friend and if the statement was directed either toward the participant (immerse), or toward a stranger (reframe). After the cue, there will be a pause, presentation of the video, and another pause. After each trial, the participant will rate how bad they feel on a 5-point scale. Resting state. Following the emotional challenge, girls will remain still and fixate on a central cross. Greater ability to flexibly engage and disengage emotion regulation in response to changing external challenges (imposed by negative, positive, and neutral videos) is expected to be reflected in the functional connectome for minutes beyond the emotional challenge task, resulting in more within-network connectivity in cognitive control networks as well as increased connectivity with emotion regions in girls engaged in proactive emotion regulation. Emotional go-nogo. This task combines a cognitive control task (go-nogo) with emotion distractors depicting negative (social rejection), positive (social acceptance), or neutral (scrambled) images taken from a validated set of stimuli. Letters are presented sequentially in a small box at the center of the screen, with emotion distractors in the background. The distractors are presented alone , prior to presentation of the letter, to make it difficult to ignore the emotional content. Girls are instructed to ignore the images and respond as quickly as possible without sacrificing accuracy with a button press to every letter (go trials), except for Xs (no-go; 25 percent of trials). Girls acquire a prepotent tendency to press and must inhibit their responses during X trials. Edited June 2020: Anticipated 75% and 100% enrollment dates as well as primary and final study completion dates and primary endpoint analyses and reporting of results were changed due to recruitment and data collection obstacles posed by the coronavirus pandemic. The new dates were estimated based on the assumption that some recruitment and data collection will resume in the fall of 2020. If this is not possible or if families are reluctant to complete sessions, completion dates may need to be changed again at a later date. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE | Emotions | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Enrolling by invitation | ||||||
Estimated Enrollment ICMJE |
150 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | April 15, 2022 | ||||||
Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 13 Years to 18 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03978871 | ||||||
Other Study ID Numbers ICMJE | 18021 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | University of Illinois at Urbana-Champaign | ||||||
Study Sponsor ICMJE | University of Illinois at Urbana-Champaign | ||||||
Collaborators ICMJE | Auburn University | ||||||
Investigators ICMJE |
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PRS Account | University of Illinois at Urbana-Champaign | ||||||
Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |