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出境医 / 临床实验 / Effect of Emotion Mindsets on Emotion Processing

Effect of Emotion Mindsets on Emotion Processing

Study Description
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.

Condition or disease Intervention/treatment Phase
Emotions Behavioral: Growth Mindset Behavioral: Control Not Applicable

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Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: Growth Mindset
Persuasive education about emotions, brain development, and teenagers' ability to learn how to manage emotions
Behavioral: Growth Mindset
Growth emotion mindset induction

Active Comparator: Brain Education
Neutral education about functions of different parts of the brain
Behavioral: Control
Brain education

Outcome Measures
Primary Outcome Measures :
  1. Mean Change from Pre to Post Mindset Manipulation on Emotion Mindset Scale (measures beliefs about whether emotions are fixed or malleable) [ Time Frame: Pre vs. Post Mindset Manipulation: baseline ]
    Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=6 High=worse outcome

  2. Mean Change from Pre to Post Mindset Manipulation on Emotional Self-efficacy Scale (measure beliefs about ability to control emotions) [ Time Frame: Pre vs. Post Mindset Manipulation: baseline ]
    Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome

  3. Mean Change from Pre to Post Mindset Manipulation on Emotional Self-efficacy Vignettes (measure beliefs about ability to control emotions in specific situations) [ Time Frame: Pre vs. Post Mindset Manipulation: baseline ]
    Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome

  4. Mean Difference in Performance on Go/nogo Task [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean performance as reflected in reaction time and accuracy across the two conditions (mindset and control)

  5. Mean Difference in Emotion Regulation Strategies [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of self-reported emotion regulation strategies across the two conditions (mindset and control)

  6. Mean Difference in Amygdala Activation [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of amygdala activation during relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)

  7. Mean Difference in Frontal Parietal Network-Amygdala Connectivity [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of frontal parietal network-amygdala connectivity during relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)

  8. Mean Change on Self-Reported State Negative Affect [ Time Frame: Pre-Trier vs. Post-Trier: baseline ]
    Will compare mean change scores across the two conditions (mindset and control)


Secondary Outcome Measures :
  1. Mean Change from Baseline in Emotion Mindset Scores at 2 Months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)

  2. Mean Change from Baseline in Emotion Mindset Scores at 4 Months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)

  3. Mean Change from Baseline in Emotional Self-efficacy Scale Scores at 2 Months (measure beliefs about ability to control emotions) [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome

  4. Mean Change from Baseline in Emotional Self-efficacy Scale Scores at 4 Months (measure beliefs about ability to control emotions) [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome

  5. Mean Change from Baseline in Emotional Self-efficacy Vignettes Scores at 2 months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)

  6. Mean Change from Baseline in Emotional Self-efficacy Vignettes Scores at 4 months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)

  7. Mean Change from Baseline in Self-Reported Emotion Regulation Strategies Scores at 2 months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)

  8. Mean Change from Baseline in Self-Reported Emotion Regulation Strategies Scores at 4 months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)

  9. Mean Difference on Self-Reported State Negative Affect [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean scores during relevant trials of the Social Evaluation Task across the two conditions (mindset and control)


Other Outcome Measures:
  1. Mean Difference in Cingulo-Opercular Network Activation [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of cingulo-opercular network activation during resting state and relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)

  2. Mean Difference in Cingulo-Opercular Network-Amygdala Connectivity [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of cingulo-opercular network-amygdala connectivity during resting state and relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)

  3. Group Differences for Whole-Brain Analyses [ Time Frame: Post Mindset Manipulation: baseline ]
    Will conduct exploratory whole-brain analyses comparing activation patterns during resting state and relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)

  4. Mean Change from Baseline in Depressive Symptoms Scores at 2 months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)

  5. Mean Change from Baseline in Depressive Symptoms Scores at 4 months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)

  6. Mean Change from Baseline in Anxiety Symptoms Scores at 2 months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)

  7. Mean Change from Baseline in Anxiety Symptoms Scores at 4 months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)


Eligibility Criteria
Layout table for eligibility information
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
Criteria

Inclusion Criteria:

  • Female age 13-18 years old
  • Over-sample (approximately 1/3 of sample) for score >= .75 SD on a screening measure of fixed mindset about emotion
  • English-speaking
  • Ability to independently complete tasks and measures

Exclusion Criteria:

  • History of surgery involving metal implants
  • Possible metal fragments in the eyes or other parts of body
  • Pacemaker
  • A history of claustrophobia
  • Braces
  • Weighing over 250 pounds
  • Pregnancy or possibility of being pregnant
  • Severe medical conditions (e.g., blind or deaf, head trauma)
  • Learning disability or other condition that interferes with ability to complete tasks
Contacts and Locations

Locations
Layout table for location information
United States, Illinois
University of Illinois
Champaign, Illinois, United States, 61820
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Auburn University
Investigators
Layout table for investigator information
Principal Investigator: Karen D Rudolph, PhD University of Illinois, Urbana Champaign
Tracking Information
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
 (submitted: July 29, 2019)
  • Mean Change from Pre to Post Mindset Manipulation on Emotion Mindset Scale (measures beliefs about whether emotions are fixed or malleable) [ Time Frame: Pre vs. Post Mindset Manipulation: baseline ]
    Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=6 High=worse outcome
  • Mean Change from Pre to Post Mindset Manipulation on Emotional Self-efficacy Scale (measure beliefs about ability to control emotions) [ Time Frame: Pre vs. Post Mindset Manipulation: baseline ]
    Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome
  • Mean Change from Pre to Post Mindset Manipulation on Emotional Self-efficacy Vignettes (measure beliefs about ability to control emotions in specific situations) [ Time Frame: Pre vs. Post Mindset Manipulation: baseline ]
    Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome
  • Mean Difference in Performance on Go/nogo Task [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean performance as reflected in reaction time and accuracy across the two conditions (mindset and control)
  • Mean Difference in Emotion Regulation Strategies [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of self-reported emotion regulation strategies across the two conditions (mindset and control)
  • Mean Difference in Amygdala Activation [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of amygdala activation during relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)
  • Mean Difference in Frontal Parietal Network-Amygdala Connectivity [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of frontal parietal network-amygdala connectivity during relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)
  • Mean Change on Self-Reported State Negative Affect [ Time Frame: Pre-Trier vs. Post-Trier: baseline ]
    Will compare mean change scores across the two conditions (mindset and control)
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Mean Change from Pre to Post Mindset Manipulation on Emotion Mindset Scale [ Time Frame: Pre vs. Post Mindset Manipulation: baseline ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Pre to Post Mindset Manipulation on Emotional Self-efficacy Scale [ Time Frame: Pre vs. Post Mindset Manipulation: baseline ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Pre to Post Mindset Manipulation on Emotional Self-efficacy Vignettes [ Time Frame: Pre vs. Post Mindset Manipulation: baseline ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Difference in Performance on Go/nogo Task [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean performance as reflected in reaction time and accuracy across the two conditions (mindset and control)
  • Mean Difference in Emotion Regulation Strategies [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of self-reported emotion regulation strategies across the two conditions (mindset and control)
  • Mean Difference in Amygdala Activation [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of amygdala activation during relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)
  • Mean Difference in Frontal Parietal Network-Amygdala Connectivity [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of frontal parietal network-amygdala connectivity during relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)
  • Mean Change on Self-Reported State Negative Affect [ Time Frame: Pre-Trier vs. Post-Trier: baseline ]
    Will compare mean change scores across the two conditions (mindset and control)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
  • Mean Change from Baseline in Emotion Mindset Scores at 2 Months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Emotion Mindset Scores at 4 Months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Emotional Self-efficacy Scale Scores at 2 Months (measure beliefs about ability to control emotions) [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome
  • Mean Change from Baseline in Emotional Self-efficacy Scale Scores at 4 Months (measure beliefs about ability to control emotions) [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome
  • Mean Change from Baseline in Emotional Self-efficacy Vignettes Scores at 2 months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Emotional Self-efficacy Vignettes Scores at 4 months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Self-Reported Emotion Regulation Strategies Scores at 2 months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Self-Reported Emotion Regulation Strategies Scores at 4 months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Difference on Self-Reported State Negative Affect [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean scores during relevant trials of the Social Evaluation Task across the two conditions (mindset and control)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Mean Change from Baseline in Emotion Mindset Scores at 2 Months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Emotion Mindset Scores at 4 Months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Emotional Self-efficacy Scale Scores at 2 Months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Emotional Self-efficacy Scale Scores at 4 Months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Emotional Self-efficacy Vignettes Scores at 2 months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Emotional Self-efficacy Vignettes Scores at 4 months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Self-Reported Emotion Regulation Strategies Scores at 2 months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Self-Reported Emotion Regulation Strategies Scores at 4 months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Difference on Self-Reported State Negative Affect [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean scores during relevant trials of the Social Evaluation Task across the two conditions (mindset and control)
Current Other Pre-specified Outcome Measures
 (submitted: June 5, 2019)
  • Mean Difference in Cingulo-Opercular Network Activation [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of cingulo-opercular network activation during resting state and relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)
  • Mean Difference in Cingulo-Opercular Network-Amygdala Connectivity [ Time Frame: Post Mindset Manipulation: baseline ]
    Will compare mean levels of cingulo-opercular network-amygdala connectivity during resting state and relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)
  • Group Differences for Whole-Brain Analyses [ Time Frame: Post Mindset Manipulation: baseline ]
    Will conduct exploratory whole-brain analyses comparing activation patterns during resting state and relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)
  • Mean Change from Baseline in Depressive Symptoms Scores at 2 months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Depressive Symptoms Scores at 4 months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Anxiety Symptoms Scores at 2 months [ Time Frame: At baseline and in approximately 2 months ]
    Will compare mean change scores across the two conditions (mindset and control)
  • Mean Change from Baseline in Anxiety Symptoms Scores at 4 months [ Time Frame: At baseline and in approximately 4 months ]
    Will compare mean change scores across the two conditions (mindset and control)
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.

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
Condition  ICMJE Emotions
Intervention  ICMJE
  • Behavioral: Growth Mindset
    Growth emotion mindset induction
  • Behavioral: Control
    Brain education
Study Arms  ICMJE
  • Experimental: Growth Mindset
    Persuasive education about emotions, brain development, and teenagers' ability to learn how to manage emotions
    Intervention: Behavioral: Growth Mindset
  • Active Comparator: Brain Education
    Neutral education about functions of different parts of the brain
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
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:

  • Female age 13-18 years old
  • Over-sample (approximately 1/3 of sample) for score >= .75 SD on a screening measure of fixed mindset about emotion
  • English-speaking
  • Ability to independently complete tasks and measures

Exclusion Criteria:

  • History of surgery involving metal implants
  • Possible metal fragments in the eyes or other parts of body
  • Pacemaker
  • A history of claustrophobia
  • Braces
  • Weighing over 250 pounds
  • Pregnancy or possibility of being pregnant
  • Severe medical conditions (e.g., blind or deaf, head trauma)
  • Learning disability or other condition that interferes with ability to complete tasks
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Identify as female
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Karen D Rudolph, PhD University of Illinois, Urbana Champaign
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