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Trial record 28 of 64 for:    MINDSET

Effects of a Single-session Implicit Theories of Personality Intervention on Early Adolescent Psychopathology

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ClinicalTrials.gov Identifier: NCT03132298
Recruitment Status : Completed
First Posted : April 27, 2017
Results First Posted : January 23, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
American Psychological Foundation
Information provided by (Responsible Party):
Jessica Schleider, Harvard University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Anxiety Symptoms
Depressive Symptoms
Interventions Other: Implicit Theories of Personality Program
Other: Control Program
Enrollment 96
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks. The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Period Title: Overall Study
Started 48 48
Completed 36 35
Not Completed 12 13
Arm/Group Title Implicit Theories of Personality Program Control Program Total
Hide Arm/Group Description This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks. The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete. Total of all reporting groups
Overall Number of Baseline Participants 48 48 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 48 participants 96 participants
<=18 years
48
 100.0%
48
 100.0%
96
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 48 participants 96 participants
13.39  (1.58) 13.26  (1.06) 13.33  (1.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 48 participants 96 participants
Female
26
  54.2%
27
  56.3%
53
  55.2%
Male
22
  45.8%
21
  43.8%
43
  44.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 48 participants 48 participants 96 participants
48
 100.0%
48
 100.0%
96
 100.0%
1.Primary Outcome
Title Change in Children's Depression Inventory (CDI) From Baseline to 9-month Follow-up
Hide Description the Children’s Depression Inventory, a 27-item self-report questionnaire that measures cognitive, affective, and behavioral symptoms of depression. Items are scored from 0-2, and scores range from 0 to 44; higher scores indicate greater symptom severity. The CDI is reliable and valid. It can distinguish youths with more or less severe depressive symptoms, as well as youths at risk for depression from non-depressed youths. Suicide- and self-harm related questions were removed for the purposes of this study.
Time Frame Baseline and 3-, 6-, and 9-month (final) follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline CDI-C scores 12.35  (1.05) 11.76  (1.07)
3-month CDI-C scores 11.54  (1.07) 11.66  (1.14)
6-month CDI-C scores 10.85  (1.16) 12.74  (1.21)
9-month CDI-C scores 10.19  (1.36) 12.47  (1.39)
2.Primary Outcome
Title Change in Children's Depression Inventory - Parent (CDI-P) From Baseline to 9-month Follow-up
Hide Description the Children’s Depression Inventory, a 27-item self-report questionnaire that measures cognitive, affective, and behavioral symptoms of depression. Items are scored from 0-2, and scores range from 0 to 44; higher scores indicate greater symptom severity. The CDI and the parent analog (CDI-P) is reliable and valid. It can distinguish youths with more or less severe depressive symptoms, as well as youths at risk for depression from non-depressed youths. Suicide- and self-harm related questions were removed for the purposes of this study.
Time Frame Baseline and 3-, 6-, and 9-month (final) follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline CDI-P scores 13.53  (1.05) 11.27  (0.96)
3-month CDI-P scores 11.41  (0.97) 10.19  (0.95)
6-month CDI-P scores 10.61  (0.94) 9.51  (0.94)
9-month CDI-P scores 9.69  (0.87) 10.84  (1.01)
3.Primary Outcome
Title Change in Screen for Child Anxiety Related Disorders - Child (SCARED-C) From Baseline to 9-month Follow-up
Hide Description Anxiety symptoms were assessed at baseline and at each follow-up point using the Screen for Child Anxiety and Related Disorders – Child and Parent versions (SCARED-C/SCARED-P). The SCARED-C and SCARED-P are child and parent versions of the same 41-item questionnaire measure of pediatric anxiety. Both differentiate between clinically anxious and nonanxious psychiatrically ill youth. Youths/parents respond to items using a 3-point Likert scale describing the degree to which statements are true about them; scores range from 0 to 82. Internal consistency, test-retest reliability, and construct validity of the SCARED are strong (Hale, Raaijmakers, Muris, & Meeus, 2005; Myers & Winters, 2002). In this study, the SCARED-C/P Total Scores were used and derived by summing all 41 items, with higher scores reflecting higher levels of anxiety.
Time Frame Baseline and 3-, 6-, and 9-month (final) follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline SCARED-C scores 28.13  (2.05) 30.54  (2.10)
3-month SCARED-C scores 24.43  (2.21) 30.47  (2.34)
6-month SCARED-C scores 24.25  (2.23) 29.76  (2.33)
9-month SCARED-C scores 23.12  (2.43) 30.44  (2.49)
4.Primary Outcome
Title Change in Screen for Child Anxiety Related Disorders - Parent (SCARED-P) From Baseline to 9-month Follow-up
Hide Description Anxiety symptoms were assessed at baseline and at each follow-up point using the Screen for Child Anxiety and Related Disorders – Child and Parent versions (SCARED-C/SCARED-P). The SCARED-C and SCARED-P are child and parent versions of the same 41-item questionnaire measure of pediatric anxiety. Both differentiate between clinically anxious and nonanxious psychiatrically ill youth. Youths/parents respond to items using a 3-point Likert scale describing the degree to which statements are true about them; scores range from 0 to 82. Internal consistency, test-retest reliability, and construct validity of the SCARED are strong. In this study, the SCARED-C/P Total Scores were used and derived by summing all 41 items, with higher scores reflecting higher levels of anxiety.
Time Frame Baseline and 3-, 6-, and 9-month (final) follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline SCARED-P scores 25.56  (1.42) 25.24  (1.48)
3-month SCARED-P scores 22.31  (1.38) 21.65  (1.74)
6-month SCARED-P scores 16.65  (1.27) 18.23  (1.70)
9-month SCARED-P scores 18.07  (1.74) 20.99  (1.93)
5.Secondary Outcome
Title Primary Control Scale for Children (PCSC)
Hide Description The PCSC is a 24-item scale measuring perceived ability to exert primary control: to influence or alter objective events or conditions through personal effort. Participants rated agreement with statements about their ability to exert primary control, with half the items worded in a positive direction (e.g., “I can do well on tests if I study hard.”) and half in a negative direction (e.g., “I cannot get other kids to like me no matter how hard I try.”). Responses range from “very true” to “very false” on a four-point Likert scale. Scores range from 0 to 72, with higher scores indicating higher (more adaptive) levels of perceived primary control.
Time Frame Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline PCSC 55.60  (1.43) 56.17  (1.46)
Immediate Post-Intervention PCSC 59.17  (1.40) 56.07  (1.42)
3-month PCSC 59.49  (1.42) 55.89  (1.58)
6-month PCSC 57.50  (1.59) 56.56  (1.69)
9-month PCSC 58.81  (1.64) 55.04  (1.65)
6.Secondary Outcome
Title Secondary Control Scale for Children (SCSC)
Hide Description The SCSC is a 20-item scale measuring perceived ability to exert secondary control: to influence the personal psychological impact of objective conditions on oneself, by adjusting oneself to fit those conditions. Item content reflects response patterns associated with various kinds of secondary control, such as finding a silver lining (“I can usually find something good to like, even in a bad situation.”) and adjusting cognition (“When something bad happens, I can find a way to think about it that makes me feel better.”). Respondents rate agreement with each item on a 4-point Likert scale from “very false” to “very true.” Scores range from 0-60, with higher scores corresponding to higher (more adaptive) levels of perceived secondary control.
Time Frame Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 48 48
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline SCSC 33.25  (1.72) 33.32  (1.75)
Immediate Post-Intervention SCSC 36.56  (1.62) 34.09  (1.42)
3-month SCSC 36.99  (1.71) 32.91  (1.83)
6-month SCSC 34.59  (1.79) 33.14  (1.86)
9-month SCSC 34.41  (2.05) 31.37  (2.09)
7.Secondary Outcome
Title Electrodermal Activity (EDA) Recovery Slope
Hide Description EDA was assessed continuously during the laboratory baseline (5 min prior to the social stress induction), social stress induction, and recovery period (5 min following the social stress induction) using Biopac MP150 hardware at a sampling rate of 1000 readings persecond and a 0.5e1 Hz bandpass filter. EDA was measured with a Biopac GSR100C amplifier and two EDA isotonic gel electrodes placed on the thenar and hypothenar eminences of the child's nondominant hand. EDA data were acquired and analyzed using AcqKnowledge 4.1 Software. Research assistants trained by the first author manually identified and removed artifacts. Averages (expressed in micro-Siemens) for EDA during the baseline, speech preparation, speech, and recovery periods were calculated for each participant. Slopes of EDA change during the recovery were calculated, expressed in microSiemens per second.
Time Frame Assessed at immediate post-intervention only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 44 43
Mean (Standard Deviation)
Unit of Measure: microsiemens/second
-.00082  (0.011) -.00024  (0.013)
8.Secondary Outcome
Title Heart Rate Variability (HRV) Recovery Slope
Hide Description HRV was assessed; specifically, the time-based root-mean square successive difference of normal-to-normal (N-to-N) intervals (rMSSD). RMSSD equates to mean shifts in the time elapsed between consecutive heartbeats, in milliseconds. It reflects parasympathetically mediated, short-term changes in HRV. More rapid post-stressor increases in rMSSD (during the 5-min post stressor recovery period) indicated a more adaptive recovery trajectory following stress. Here, rMSSD was computed using the Acqknowledge automated time-series HRV analysis function.
Time Frame Assessed at immediate post-intervention only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 36 40
Mean (Standard Deviation)
Unit of Measure: msec
.008  (.034) -.007  (.040)
9.Other Pre-specified Outcome
Title Beck Depression Inventory
Hide Description Parental depressive symptoms were measured at baseline at 3-, 6-, and 9-month follow-up assessments using the Beck Depression Inventory-II (BDI-II). The BDI is one of the most widely used and evaluated self- report measures of adult depressive symptoms. For each of its 21 items, respondents select among four alternative responses reflecting the increasing levels of symptom severity (0 = no symptom present to 3 = severe symptom present). The total score was used in this study, with a possible score range of 0 to 63 at each assessment point. Higher scores indicate higher levels of depressive symptoms.
Time Frame Baseline and 3-, 6-, and 9-month (final) follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: score on a scale
BDI baseline 7.92  (8.19) 6.91  (6.26)
BDI 3-month 8.61  (9.66) 10.89  (10.75)
BDI 6-month 7.54  (7.38) 7.80  (9.00)
BDI 9-month 6.74  (6.48) 7.44  (6.82)
10.Other Pre-specified Outcome
Title Beck Anxiety Inventory
Hide Description Parental anxiety symptoms were measured at baseline at 3-, 6-, and 9-month follow-up assessments using the Beck Anxiety Inventory (BAI; Beck & Steer, 1993), a widely-used self-report measure of anxiety in adults for use in clinical, community, and research settings. Respondents report the extent to which they have been bothered by each of 21 symptoms over the preceding week. Each item has four possible answer choices: Not at All; Mildly; Moderately, and Severely. Because the BAI’s 21 items (each rated 0 to 3, for a total possible scores ranging from 0 to 63 - higher scores indicate higher levels of anxiety) describe the emotional, physiological, and cognitive symptoms of anxiety but not depression, it can discriminate anxiety from depression in adults.
Time Frame Baseline and 3-, 6-, and 9-month (final) follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: score on a scale
BAI Baseline 8.60  (9.20) 6.57  (7.20)
BAI 3 month 11.48  (9.89) 9.58  (13.51)
BAI 6 month 5.51  (5.64) 3.68  (3.92)
BAI 9 month 6.23  (5.41) 5.47  (6.75)
11.Other Pre-specified Outcome
Title Brief Family Assessment Measure
Hide Description The BFAM is a 14-item parent report questionnaire assessing perceptions of family functioning during the previous 2 weeks. This instrument was created to provide an operational definition and means of measuring the seven constructs in the Process Model of Family Functioning; it includes two items relating to each construct. Items such as “We take the time to listen to each other” and “When things aren’t going well it takes too long to work them out” are scored on a 5-point scale. Items are summed to create a total score (range: 0-70), with higher scores indicating greater familial dysfunction.
Time Frame Baseline and 3-, 6-, and 9-month (final) follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: score on a scale
BFAM baseline 10.60  (4.89) 11.48  (6.95)
BFAM 3 months 10.88  (5.11) 12.86  (5.66)
BFAM 6 months 11.38  (6.30) 13.00  (5.84)
BFAM 9 months 10.29  (5.31) 12.44  (6.94)
12.Other Pre-specified Outcome
Title Implicit Personality Theory Questionnaire
Hide Description The Implicit Personality Theory Questionnaire asks participants to indicate on a 1 (really disagree) to 6 (really agree) scale the extent to which they endorse three statements: “You have a certain personality, and it is something that you can't do much about”; “Your personality is something about you that you can't change very much”; and “Either you have a good personality or you don't, and there is really very little you can do about it.” Numerical scores are summed to yield a single, total implicit theory of personality score (score range=0-18); higher scores indicate a stronger entity theory of personality, and lower scores indicate stronger incremental theories of personality.
Time Frame Baseline, immediately post-intervention, and 3-, 6-, and 9-month follow-up
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description:
This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks.
The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
Overall Number of Participants Analyzed 48 48
Mean (Standard Deviation)
Unit of Measure: score on a scale
Implicit Theories basline 10.98  (3.15) 9.93  (3.02)
Implicit Theories post intervention 6.77  (3.83) 8.69  (3.25)
Implicit Theories 3 month follow-up 9.72  (3.36) 9.91  (4.16)
Implicit Theories 6 month follow-up 8.75  (2.93) 10.06  (3.51)
Implicit Theories 9 month follow-up 9.23  (3.55) 10.28  (3.78)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Implicit Theories of Personality Program Control Program
Hide Arm/Group Description This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people’s traits are malleable, given the brain’s capacity for change; 3. Further vignettes by older youths describing times when they used “growth mindsets” to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants’ lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks. The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.
All-Cause Mortality
Implicit Theories of Personality Program Control Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Implicit Theories of Personality Program Control Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Implicit Theories of Personality Program Control Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/48 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Jessica Schleider
Organization: Stony Brook University
Phone: 631-632-4131
EMail: jessica.schleider@stonybrook.edu
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Responsible Party: Jessica Schleider, Harvard University
ClinicalTrials.gov Identifier: NCT03132298     History of Changes
Other Study ID Numbers: IRB15-0855
1F31MH108280-01 ( U.S. NIH Grant/Contract )
5F31MH108280-02 ( U.S. NIH Grant/Contract )
First Submitted: April 24, 2017
First Posted: April 27, 2017
Results First Submitted: October 2, 2018
Results First Posted: January 23, 2019
Last Update Posted: February 7, 2019