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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

Brief Summary:
The goal of the project is to test whether a single-session intervention teaching incremental theories of personality, or the belief that one's personality is malleable, can strengthen recovery from social stress and reduce the development of anxiety and depression during early adolescence. Results may suggest a scalable, cost-effective approach to improving youths' coping capacities and preventing adverse mental health outcomes over time.

Condition or disease Intervention/treatment Phase
Anxiety Symptoms Depressive Symptoms Other: Implicit Theories of Personality Program Other: Control Program Not Applicable

Detailed Description:
Efforts to prevent and reduce mental health problems in youths have advanced greatly in recent years. However, these advances have not reduced rates of youth mental illness on a large scale. Thus, a great need exists for novel, scalable, and low-cost approaches to reducing mental health problems in youth. Ideally, such approaches would be mechanism-targeted: that is, they would act on specific developmental processes that underlie psychological disorders. The proposed research aims to address this need by testing whether a single-session intervention teaching incremental theories of personality, or the belief that one's personality is malleable—as opposed to entity theories of personality, or the belief that one's personality is fixed and unchangeable—can strengthen recovery from social stress and prevent the development of anxiety and depression during early adolescence. Compared to incremental theories, entity theories of personal traits have demonstrated cross-sectional and prospective relations with greater anxiety and depression in youths. Further, a single-session incremental personality theories intervention reduced the development of depressive symptoms in a community sample of adolescents, supporting these theories as powerful intervention and/or prevention targets, even when taught in a brief format. Specifically, this project has two aims. Aim 1 is to evaluate the effect of the implicit theories intervention on two candidate mechanisms of action, or targets, identified by prior research: arousal (measured via physiological reactivity following social stress) and loss (here, perceived loss of behavioral control) in youths 12-15 years of age. Following a lab-based social stress induction, I hypothesize that participants receiving the intervention will recover from stress more rapidly, as indicated by measures of arousal (heart rate variability; electrodermal activity levels) and self-reported loss (increased self-reported perceived control) compared to participants who do not receive the intervention. Aim 2 is to evaluate the effects of the single-session incremental theories intervention on anxiety and depression over a nine-month follow-up period. I will test whether the intervention, compared to a control protocol, reduces symptoms of anxiety an depression the development of anxiety and depression; I will also assess whether this change is a direct result of shifts in the two aforementioned targets (arousal; loss). I predict more positive trajectories in anxiety and depression for youth receiving the intervention, relative to those who do not receive the intervention, across nine months. I will also test whether these trajectories are mediated by changes in the targets described in Aim 1. Finally, regardless of outcomes for Aims 1 and 2, baseline, postintervention, and 9-month measures will be used to map links among implicit theories, interventions targeting those theories, social stress recovery, and youth anxiety and depression over time. Findings may suggest a cost-effective, scalable intervention that improves youth resiliency and mental health.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants (N=96), ages 12-15 will be randomized to receive one of two a 30-minute, computer-based programs: (1) a 'growth mindset' program, teaching that personal traits and characteristics are malleable; or (2) a control program, designed to mimic 'supportive therapy,' teaching the value of sharing one's feelings with close others.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of a Single-session Implicit Theories of Personality Intervention on Recovery From Social Stress and Long-term Psychological Functioning in Early Adolescents
Actual Study Start Date : August 17, 2015
Actual Primary Completion Date : October 30, 2016
Actual Study Completion Date : October 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Implicit Theories of Personality Program
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
Other: Implicit Theories of Personality Program
This 30-minute, self-administered computer program teaches youths that personality is malleable, as opposed to fixed, due to the human brain's constant potential for change and growth (i.e., neuroplasticity).
Other Name: Growth Mindset of Personality Program

Active Comparator: Control Program
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.
Other: Control Program
This 30-minute, self-administered computer program was designed to control for nonspecific aspects of completing a series of computer-based activities in the context of the present study. It was also designed to mimic 'supportive therapy' that youths might receive in usual care settings, stressing the importance of sharing one's feelings with close others.
Other Name: Supportive Therapy (ST) Program




Primary Outcome Measures :
  1. Change in Children's Depression Inventory (CDI) From Baseline to 9-month Follow-up [ Time Frame: Baseline and 3-, 6-, and 9-month (final) follow-up ]
    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.

  2. Change in Children's Depression Inventory - Parent (CDI-P) From Baseline to 9-month Follow-up [ Time Frame: Baseline and 3-, 6-, and 9-month (final) follow-up ]
    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.

  3. Change in Screen for Child Anxiety Related Disorders - Child (SCARED-C) From Baseline to 9-month Follow-up [ Time Frame: Baseline and 3-, 6-, and 9-month (final) follow-up ]
    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.

  4. Change in Screen for Child Anxiety Related Disorders - Parent (SCARED-P) From Baseline to 9-month Follow-up [ Time Frame: Baseline and 3-, 6-, and 9-month (final) follow-up ]
    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.


Secondary Outcome Measures :
  1. Primary Control Scale for Children (PCSC) [ Time Frame: Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up ]
    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.

  2. Secondary Control Scale for Children (SCSC) [ Time Frame: Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up ]
    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.

  3. Electrodermal Activity (EDA) Recovery Slope [ Time Frame: Assessed at immediate post-intervention only ]
    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.

  4. Heart Rate Variability (HRV) Recovery Slope [ Time Frame: Assessed at immediate post-intervention only ]
    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.


Other Outcome Measures:
  1. Beck Depression Inventory [ Time Frame: Baseline and 3-, 6-, and 9-month (final) follow-up ]
    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.

  2. Beck Anxiety Inventory [ Time Frame: Baseline and 3-, 6-, and 9-month (final) follow-up ]
    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.

  3. Brief Family Assessment Measure [ Time Frame: Baseline and 3-, 6-, and 9-month (final) follow-up ]
    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.

  4. Implicit Personality Theory Questionnaire [ Time Frame: Baseline, immediately post-intervention, and 3-, 6-, and 9-month follow-up ]
    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.



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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 12 to 15 (inclusive) at time of study enrollment
  • One or more of the following (3) criteria, all assessed through an initial parent phone screen: (1) t-score of >60 (84th percentile) on any disorder subscale of the Revised Child Anxiety and Depression Scale-Parent (RCADS-P, Ebesutani et al., 2010); (2) school-based accommodations for anxiety- or depression-related symptoms, such as through an Individual Education Plan (IEP) or a 504 plan; (3) anxiety and/or depression treatment sought for the youth within the previous 3 years.

Exclusion Criteria:

  • Psychosis, intellectual disability, pervasive developmental/autism spectrum disorder, and suicidal ideation leading to hospitalization or attempts within the past year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132298


Locations
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United States, Massachusetts
Harvard University
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Harvard University
National Institute of Mental Health (NIMH)
American Psychological Foundation
Investigators
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Principal Investigator: Jessica L Schleider, M.A. Harvard University

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jessica Schleider, PhD candidate, 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 Posted: April 27, 2017    Key Record Dates
Results First Posted: January 23, 2019
Last Update Posted: February 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD sharing plan is consistent with NIH guidelines for sharing participant-level data at the conclusion of the fellowship period.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms