NCT03978871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 17, 2025

Completed
Last Updated

April 17, 2025

Status Verified

March 1, 2025

Enrollment Period

3.8 years

First QC Date

June 5, 2019

Results QC Date

October 25, 2023

Last Update Submit

March 27, 2025

Conditions

Keywords

BrainFunctional NeuroimagingStress, PsychologicalEmotionsPsychology, Developmental

Outcome Measures

Primary Outcomes (12)

  • Mean Change From Pre to Post Mindset Manipulation on Emotion Mindset Scale (Measures Beliefs About Whether Emotions Are Fixed or Malleable)

    Participants completed a six-item fixed emotion mindset measure (EMS-fixed) measure, prior to (pre-induction EMS) and following the induction lessons (post-induction EMS). Items were drawn from the Implicit Theories of Emotion Scale (Tamir et al., 2007) and the Emotion Mindset Scale (EMS; Livingstone, 2013). Participants rated each item on a 6-point scale (1 = Strongly Disagree to 6 =Strongly Agree). Means were computed for these items, with higher scores representing a higher fixed emotion mindset mindset. For this analysis, we compared mean change scores across the two conditions (mindset and control). Minimum=1 Maximum=6 High= more fixed emotion mindset, worse outcome

    Pre vs. Post Mindset Manipulation: baseline

  • Mean Change From Pre to Post Mindset Manipulation on Emotional Self-efficacy Scale (Measure Beliefs About Ability to Control Emotions)

    Participants completed a measure assessing their perceived ability to manage emotions prior to and following the induction. Items were derived from the using and managing your own emotions subscale of the Youth-Emotional Self-efficacy Scale (5 items; Qualter et al., 2015). Participants rated the items on a 5-point Likert scale (1 = Disagree Strongly to 5 = Agree Strongly). Scores were computed as the mean of the items, with higher scores indicating greater emotion regulation self-efficacy. Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome

    Pre vs. Post Mindset Manipulation: baseline

  • Mean Change From Pre to Post Mindset Manipulation on Emotional Self-efficacy Vignettes (Measure Beliefs About Ability to Control Emotions in Specific Situations)

    To assess emotion regulation self-efficacy participants completed a self-efficacy measure adapted from Tamir and colleagues (2007). Prior to and following the induction, participants were asked to rate 12 emotion-eliciting events drawn from daily life. Three scenarios were adapted from the Tamir self-efficacy measure (Tamir et al. 2007. Participants rated how confident they were in their ability to control their emotions in each scenario on a 5-point scale (1 = Not at All to 5 = Very Much). Scores were computed as the mean of the items, with higher scores reflecting greater self-efficacy. Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome

    Pre vs. Post Mindset Manipulation: baseline

  • Mean Difference in Performance on Go/Nogo Task- Reaction Time

    The socioemotional Go/No-go presents participants with a socially appetitive image, socially aversive image, or neutral image. After the image, a white box with a black letter was superimposed on the image for 500 ms. Participants were instructed to respond as quickly as possible to every letter. Responses during these 500 ms were used for analysis. Mean reaction times (RT) in milliseconds to positive stimuli (pos.correctgoRT), negative stimuli (neg.correctgoRT) and neutral stimuli (neu.correctgoRT) were calculated, with higher numbers indicating slower RT. Will compare mean performance as reflected in reaction time across the two conditions (mindset and control)

    Post Mindset Manipulation: baseline

  • Mean Difference in Performance on Go/Nogo Task- Accuracy

    The socioemotional Go/No-go presents participants with a socially appetitive image, socially aversive image, or neutral image. After, a letter was superimposed on the image. Participants were instructed to respond to every letter except for 'X'. Participants completed 4 blocks of each condition. Accurate responses to the letters after the socially appetitive images (positive accuracy), socially aversive image (negative accuracy) and neutral image (neutral accuracy) were indicated (0-1 scale). Mean scores across the four blocks were calculated, with higher scores indicating more accuracy. Will compare mean performance as reflected in accuracy across the two conditions (mindset and control)

    Post Mindset Manipulation: baseline

  • Mean Difference in Emotion Regulation Strategies on the Emotion Regulation Strategy Scale

    Participants completed a measure to assess the emotion regulation strategies (ERS) they used during the Trier Social Stress Test (TSST). Items were rated on a 5-point scale (1 = Not at All to 5 = Very Much). Factor analyses yielded three emotion regulation strategies factors- involuntary dysregulation, proactive engagement, and cognitive avoidance. Scores were computed as the mean of the items on each factor (1 = Not at All to 5 = Very Much), with higher scores reflecting higher levels of each type of response. In analyses, we compare mean scores for each of these factors across the two conditions (mindset and control). Higher scores on proactive engagement are considered adaptive and higher scores on involuntary dysregulation and cognitive avoidance are considered maladaptive.

    Post Mindset Manipulation: baseline

  • Mean Difference in Parameter Estimates of BOLD Signal for Amygdala Activation- Social Evaluation Task

    The Social Evaluation Task (SET) examines emotion reactivity and regulation with social stimuli. Stimuli consisted of video clips with actors expressing criticism (negative condition), praise (positive condition) or neutral statements (neutral condition). Participants were asked to imagine the person was either an actor practicing lines (reframe condition), or a close friend (immerse condition). Participants were subsequently asked to rate how they felt on a 5 item Likert scale from "Very Good" to "Very Bad". To reduce the influence of carryover effects across blocks, participants also engaged in a counting task at the conclusion of each block. We conducted ROI analyses of bilateral amygdalae to compare activation patterns during relevant trials of the Social Evaluation Task (negative immerse \> neutral immerse) across experimental conditions (mindset vs control).

    Post Mindset Manipulation: baseline

  • Mean Difference in Parameter Estimates of BOLD Signal for Amygdala Activation- Go/No-go Task

    The Socioemotional Go/No-go Task examines inhibitory control in the presence of socioemotional distractors. Participants were presented with a socially aversive image, or neutral image for 300ms. After the image, a white box with a black letter was superimposed on the image for 500 ms. Participants were instructed to respond quickly to every letter except an infrequent nontarget letter. We conducted ROI analyses of bilateral amygdalae to compare activation patterns of emotion reactivity during relevant trials of the Socioemotional Go/No-go Task (negative \> neutral) across experimental conditions (mindset vs control).

    Post Mindset Manipulation: baseline

  • Mean Difference in Parameter Estimates of BOLD Signal for Frontal Parietal Network-Amygdala Connectivity- Social Evaluation Task

    The Social Evaluation Task (SET) examines emotion reactivity and regulation with social stimuli. Stimuli consisted of video clips with actors expressing criticism (negative condition), praise (positive condition) or neutral statements (neutral condition). Participants were asked to imagine the person was either an actor practicing lines (reframe condition), or a close friend (immerse condition). Participants were subsequently asked to rate how they felt on a 5 item Likert scale from "Very Good" to "Very Bad". To reduce the influence of carryover effects across blocks, participants also engaged in a counting task at the conclusion of each block. Psychophysiological interaction (PPI) analysis was conducted in SPM12 to examine task-dependent changes in connectivity between amygdalae and frontoparietal network (FPN) during relevant trials (negative reframe \> negative immerse) across experimental conditions (mindset vs control).

    Post Mindset Manipulation: baseline

  • Mean Difference in Parameter Estimates of BOLD Signal for Frontal Parietal Network-Amygdala Connectivity- Go/No-go Task

    The Socioemotional Go/No-go Task examines inhibitory control in the presence of socioemotional distractors. Participants were presented with a socially aversive image, or neutral image for 300ms. After the image, a white box with a black letter was superimposed on the image for 500 ms. Participants were instructed to respond quickly to every letter except an infrequent nontarget letter. Psychophysiological interaction (PPI) analysis was conducted in SPM12 to examine task-dependent changes in connectivity between amygdalae and frontoparietal network (FPN) during relevant trials of the Socioemotional Go/No-go Task (negative \> neutral) across experimental conditions (mindset vs control).

    Post Mindset Manipulation: baseline

  • Mean Change on Self-Reported State Negative Affect

    Before (Pre-trier negative affect) and after (Post-trier negative affect) completing the Trier Social Stress Test (TSST) at baseline, participants completed ratings of negative emotions (10 items), modified from another affect measure (Owens et al., 2019), to test the efficacy of the TSST. Participants rated their emotions on a 100-point scale (0 = Not at All to 100 = Extremely) to indicate the extent they were feeling a negative emotion at that particular moment. Scores were computed as the mean of the items, with higher scores reflecting higher levels of negative emotions. In this analysis, we compared mean change scores across the two conditions (mindset and control).

    Pre-Trier vs. Post-Trier: baseline

  • Mean Difference on Self-Reported Affect on Social Evaluation Task

    The Social Evaluation Task examines emotion reactivity and regulation in the context of social stimuli. Stimuli consisted of video clips with actors expressing criticism (negative immerse or reframe), praise (positive immerse or reframe), or neutral statements (neutral immerse). In immerse trials, participants imagined that the person was a close friend. During the reframe trials, participants imagined that the person was an actor. After each trial, participants rated how they felt from 1 (Very Good) to 5 (Very Bad). Means of each condition were computed with higher scores indicating more negative emotions. In this analysis, we compared mean difference between criticism and praise vs. neutral trials across the two conditions (mindset and control) for the Social Evaluation Task

    Post Mindset Manipulation: baseline

Secondary Outcomes (8)

  • Mean Change From Baseline to 2 Months in Emotion Mindset Scale Scores

    At baseline and in approximately 2 months

  • Mean Change From Baseline to 4 Months in Emotion Mindset Scores

    At baseline and in approximately 4 months

  • Mean Change From Baseline to 2 Months in Emotional Self-efficacy Scale Scores (Measure Beliefs About Ability to Control Emotions)

    At baseline and in approximately 2 months

  • Mean Change From Baseline to 4 Months in Emotional Self-efficacy Scale Scores (Measure Beliefs About Ability to Control Emotions)

    At baseline and in approximately 4 months

  • Mean Change From Baseline to 2 Months in Emotional Self-efficacy Vignettes Scores

    At baseline and in approximately 2 months

  • +3 more secondary outcomes

Other Outcomes (11)

  • Mean Difference in Parameter Estimates of BOLD Signal for Cingulo-Opercular Network Activation- Social Evaluation Task

    Post Mindset Manipulation: baseline

  • Mean Difference in Parameter Estimates of BOLD Signal for Cingulo-Opercular Network Activation- Go/No go Task

    Post Mindset Manipulation: baseline

  • Mean Difference in Parameter Estimates of BOLD Signal for Cingulo-Opercular Network Activation- Resting State

    Post Mindset Manipulation: baseline

  • +8 more other outcomes

Study Arms (2)

Growth Mindset

EXPERIMENTAL

Persuasive education about emotions, brain development, and teenagers' ability to learn how to manage emotions

Behavioral: Growth Mindset

Brain Education

ACTIVE COMPARATOR

Neutral education about functions of different parts of the brain

Behavioral: Brain Education

Interventions

Growth MindsetBEHAVIORAL

Growth emotion mindset induction

Growth Mindset
Brain EducationBEHAVIORAL

Brain education

Brain Education

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIdentify as female
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Champaign, Illinois, 61820, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Karen Rudolph
Organization
University of Illinois, Urbana-Champaign

Study Officials

  • Karen D Rudolph, PhD

    University of Illinois, Urbana Champaign

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 7, 2019

Study Start

August 27, 2018

Primary Completion

June 27, 2022

Study Completion

October 31, 2022

Last Updated

April 17, 2025

Results First Posted

April 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

We will share our behavioral data publicly on the Open Science Framework upon publication. De-identified neuroimaging data will be organized according to the Brain Imaging Data Structure (BIDS) guidelines, a standard developed to provide a consistent framework for storing and sharing neuroimaging data. These data will then be shared on the openfMRI platform https://openfmri.org upon publication.

Time Frame
Upon publication

Locations