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

January 22, 2019 updated by: Jessica Schleider, Harvard University

Effects of a Single-session Implicit Theories of Personality Intervention on Recovery From Social Stress and Long-term Psychological Functioning in Early Adolescents

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Harvard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Supportive Therapy (ST) Program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3-, 6-, and 9-month (final) follow-up
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.
Baseline and 3-, 6-, and 9-month (final) follow-up
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.
Baseline and 3-, 6-, and 9-month (final) follow-up
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.
Baseline and 3-, 6-, and 9-month (final) follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up
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.
Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up
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.
Assessed at immediate post-intervention only
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.
Assessed at immediate post-intervention only

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3-, 6-, and 9-month (final) follow-up
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.
Baseline and 3-, 6-, and 9-month (final) follow-up
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.
Baseline and 3-, 6-, and 9-month (final) follow-up
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.
Baseline, immediately post-intervention, and 3-, 6-, and 9-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
American Psychological Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica L Schleider, M.A., Harvard University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB15-0855
  • 1F31MH108280-01 (U.S. NIH Grant/Contract)
  • 5F31MH108280-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD sharing plan is consistent with NIH guidelines for sharing participant-level data at the conclusion of the fellowship period.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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