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Building Evidence-Based Supports for Teens Via Technology (BEST-TECH)

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ClinicalTrials.gov Identifier: NCT03858881
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Limbix Health, Inc.
Information provided by (Responsible Party):
Stony Brook University

Brief Summary:

Major depression (MD) is the leading cause of disability in youth, with a global economic burden of >$210 billion annually. However, up to 70% of youth with MD do not receive services. Even among those who do access treatment, 30-65% fail to respond, demonstrating a significant need for more potent, accessible interventions for adolescent depressive symptoms and disorders.

The goal of this project is to assess the acceptability and effectiveness of a novel, single-session, virtual reality-based depression intervention—the VR Personality Project—teaching growth mindset: the belief that personal behaviors and characteristics, such as depressive symptoms, are malleable rather than fixed. In a previous trial, a single-session growth mindset intervention significantly reduced depressive symptoms in high symptom-adolescents; however, this intervention did not benefit all adolescents uniformly. For instance, the intervention reduced depression in adolescents who reported post-intervention increases in perceived control, but it did not lead to significant depression reductions in adolescents who reported small or no increases in perceived control. Thus, the VR Personality Project was designed to systematically target and increase adolescents' perceived control by offering a more immersive, active, and user-directed intervention experience than the web-based SSI can provide. By targeting an identified predictor of intervention response, the VR Personality Project may be lead to larger reductions in depression than the existing web-based mindset SSI.

To test this possibility, adolescents with elevated depressive symptoms or at high risk for depressive symptoms (N=159; ages 12-16) will be randomized to one of three intervention conditions: the VR Personality Project; the web-based growth mindset SSI tested previously; or an active control SSI, also tested previously. Adolescents and their parents will report on their depression symptoms, perceived control, and related domains of functioning at pre-intervention, post-intervention, and at three- and nine-month follow-ups. We predict that the VR and web-based SSIs will both lead to larger reductions in adolescent symptoms relative to the control SSI. Additionally, we predict that the VR-based SSI will lead to larger reductions in depression than the online SSI, and that these symptom reductions will be mediated by increases in adolescents' perceived control. Results may identify a particularly potent, mechanism-targeted, brief intervention for adolescent depression.


Condition or disease Intervention/treatment Phase
Depression Behavioral: PROJECT PERSONALITY Behavioral: VR PERSONALITY PROJECT Behavioral: SHARING FEELINGS PROGRAM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants will be partly blind to condition =. A computer-based survey will randomize participants into one of three conditions: an online mindset program, an online control program, or a virtual reality program. If a participant is randomized into one of the first 2 programs, the participant will know that s/he is not assigned to the VR program, but neither the experimenter nor the participant will be aware of which of the two computer-based programs s/he is completing. However, both participants and the experimenter leading the study visit will be aware of whether he participant was allocated to the VR condition (specific equipment set-up is required). The experimenters leading the study visits will be trained RAs not involved in data analysis. The study PI will remain blind to participants' condition assignments.
Primary Purpose: Treatment
Official Title: Building Evidence-Based Supports for Teens Via Technology
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PROJECT PERSONALITY Behavioral: PROJECT PERSONALITY
PROJECT PERSONALITY is self-administered by youth via Qualtrics and is 30 minutes in duration. The intervention includes five elements: 1. An introduction to the brain, including a lesson on neuroplasticity (how and why our behaviors are controlled by thoughts and feelings in the brains, which have potential for change); 2. Testimonials from older youths who describe their views that people's traits are malleable, given the brain's plasticity; 3. Additional vignettes written by older youths, describing times when they used "growth mindsets" to persevere through social and emotional setbacks; 4. A summary of selected scientific studies suggesting that personality can, and often does, change in positive ways over time; and 5. An exercise in which the participants write notes to younger students, drawing on scientific information to describe the malleability of people's personal traits
Other Name: Web-based growth mindset intervention

Experimental: VR PERSONALITY PROJECT Behavioral: VR PERSONALITY PROJECT
The VR PERSONALITY PROJECT contains similar elements as PROJECT PERSONALITY, including a lesson on neuroplasticity; testimonials from older youths; information about research on the malleability of personal traits; and an exercise wherein the participant provides advice to a student in the VR environment who has experienced a peer-related setback. Content is delivered by characters in the VR environment (hired/filmed actors) who guide youths through the program, providing scientific information and personal stories. Completion time is 30-40 minutes. The key difference between the VR and web-based mindset intervention is the delivery system, and by extension the level of immersion each program offers. The VR program is designed to be immersive, fun and interactive; youth choose to speak to various scientists and students within the VR environment and navigate themselves from scene to scene. In the online program, participants automatically view a series of text-based activities.
Other Name: Virtual reality growth mindset intervention

Placebo Comparator: SHARING FEELINGS PROGRAM Behavioral: SHARING FEELINGS PROGRAM
The web-based supportive therapy (ST) intervention, called the Sharing Feelings Program, is delivered via Qualtrics, self-administered by youth, and 30 minutes in duration. It aims to encourage youths to identify and express feelings to close others and does not teach specific skills or beliefs. It is designed to control for nonspecific aspects of intervention, including engagement in a technology-based program. It mirrors the web-based growth mindset intervention as closely as possible, including vignettes written by older youths who describe times when they benefited from sharing their feelings with friends or family.
Other Name: Web-based supportive therapy intervention




Primary Outcome Measures :
  1. Change in Children's Depression Inventory - 2 (Youth Report) [ Time Frame: Baseline to 3- and 9-month follow-up ]
    Change in youth reported depressive symptoms, total score derived from 28-item CDI-2. Scores range from 0-56, with higher scores indicating higher levels of depression.

  2. Change in Children's Depression Inventory - 2 (Parent Report) [ Time Frame: Baseline to 3- and 9-month follow-up ]
    Parent reported youth depressive symptoms, total score derived from 17-item parent-report version of CDI-2. Scores range from 0-54, and higher scores indicate greater youth depression severity.


Secondary Outcome Measures :
  1. Change in Screen for Anxiety Related Disorders (Youth Report) [ Time Frame: Baseline to 3- and 9-month follow-up ]
    Youth reported anxiety symptoms, total score derived from 41-item SCARED. Scores range from 0 to 82. Higher scores indicate greater anxiety severity.

  2. Change in Screen for Anxiety Related Disorders (Parent Report) [ Time Frame: Baseline to 3- and 9-month follow-up ]
    Change in parent reported youth anxiety symptoms, total score derived from 41-item SCARED-P. Scores range from 0 to 82. Higher scores indicate greater anxiety severity.

  3. Change in Perceived Control Scale for Children [ Time Frame: Baseline to immediate post-intervention, 3-month, and 9-month follow-ups. ]
    Youth-reported perceptions of control over behavioral responses to setbacks. Total score is derived from the sum of all items in the 24-item scale (range: 0 - 72), with higher scores reflecting higher levels of perceived control.

  4. Change in Secondary Control Scale for Children [ Time Frame: Baseline to immediate post-intervention, 3-month, and 9-month follow-ups. ]
    Youth-reported perceptions of control over emotional responses to setbacks. Total score is derived from the sum of all items in the 20-item scale (range: 0 - 60), with higher scores reflecting higher levels of perceived control.

  5. Change in UCLA Loneliness Scale [ Time Frame: Baseline to immediate post-intervention, 3-month, and 9-month follow-ups. ]
    The ULS is a widely used self-report scale of loneliness in adolescents. The 20-item version will be used here. Adolescents rate how often they experience loneliness in various contexts (e.g., 'how often do you feel part of a group of friends?' 'How often do you feel there is no one you can turn to?'). Higher scores indicate higher levels of loneliness. Scores range from 0-60.

  6. Change in Attitudes Toward Therapy Scale - Youth [ Time Frame: Baseline to immediate post-intervention, 3-month, and 9-month follow-ups. ]
    One-item measure used to assess youths' perceptions that therapy/counseling would be useful in reducing emotional or behavioral difficulties, rated on a 0-10 scale (total score range: 0-10). Higher scores indicate stronger beliefs that therapy may help reduce mental health problems, whereas lower scores indicate weaker beliefs that therapy may help reduce mental health problems.

  7. Change in Attitudes Toward Therapy Scale - Parent [ Time Frame: Baseline to 3-month and 9-month follow-ups. ]
    One-item measure used to assess parents' perceptions that therapy/counseling would be useful in reducing their child's emotional or behavioral difficulties, rated on a 0-10 scale (total score range: 0-10). Higher scores indicate stronger beliefs that therapy may help reduce mental health problems, whereas lower scores indicate weaker beliefs that therapy may help reduce mental health problems.

  8. Change in Beck Hopelessness Scale-4 [ Time Frame: Baseline to immediate post-intervention, 3-month, and 9-month follow-ups. ]
    Respondents (youths) report agreement with 4 items indicating levels of hopelessness about the future. Higher summed scores reflect greater levels of hopelessness, and scores range from 0-12.

  9. Change in Implicit Theories of Personality Questionnaire, youth-report [ Time Frame: Baseline to immediate post-intervention, 3-month, and 9-month follow-ups ]
    Respondents rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-7 Likert scale (e.g. "Your personality is something about you that you can't change very much"). Higher mean scores on these three items indicate a stronger fixed personality mindset, a lower scores, a stronger growth personality mindset (range: 1-7).


Other Outcome Measures:
  1. Change in Implicit Theories of Personality Questionnaire, parent-report [ Time Frame: Baseline to 3-month and 9-month follow-ups ]
    Respondents rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-7 Likert scale (e.g. "Your personality is something about you that you can't change very much"). Higher mean scores on these three items indicate a stronger fixed personality mindset, a lower scores, a stronger growth personality mindset (range: 1-7).

  2. Change in Brief Symptom Inventory-18 [ Time Frame: Baseline to 3-month and 9-month follow-ups ]
    The Brief Symptom Inventory-18 (BSI-18) assesses self reported parent psychopathology and distress. Adult respondents rate endorsement of 18 physical and emotional complaints on a 0-4 Likert scale. The total sum score yields an additional total distress score (range: 0-72). Higher scores indicate higher levels of overall psychological distress.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Youth is between the ages of 12-16 years (inclusive) at the time of study enrollment
  • Youth has one parent or legal guardian willing to participate in the study (i.e., to be present for the lab visit and to complete questionnaires throughout the study period)
  • Youth speaks English well enough to complete online or virtual reality-based intervention activities, which are available in English only
  • Indication of elevated risk for youth depression. This criterion may be met in one of two ways (or both ways): (a) The adolescent exhibits elevations in depressive symptoms (subclinical or greater symptom elevations, corresponding to 80th percentile or higher, based on parent-report CDI 2 conducted an initial phone screen); (b) The adolescent received treatment for depression within the previous 2 years (depression tends to recur, so past treatment receipt indicates elevated risk). Past treatment receipt will be assessed via parent report at the time of the phone screen.

Exclusion Criteria:

  • Intellectual disability, as this may undermine comprehension of intervention materials
  • Adolescent is non-English speaking, as the virtual reality and online interventions are available in English only;
  • Adolescent was hospitalized or received residential/inpatient treatment for suicide attempt or self-harming behaviors within the past 2 months, as the interventions being tested in this study are not designed for adolescents with acute medical and/or psychiatric treatment needs

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): NCT03858881


Contacts
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Contact: Jessica L Schleider, PhD 631-632-4131 jessica.schleider@stonybrook.edu

Locations
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United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794-2500
Contact: Jessica L Schleider, PhD    631-632-4131    jessica.schleider@stonybrook.edu   
Sponsors and Collaborators
Stony Brook University
Limbix Health, Inc.
Investigators
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Principal Investigator: Jessica L Schleider, PhD Stony Brook University

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Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT03858881     History of Changes
Other Study ID Numbers: 1337335-2
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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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