Building Evidence-Based Supports for Teens Via Technology

NCT03858881 | Unknown

• 1 other identifier: 1337335-2
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Change in Children's Depression Inventory - 2 (Youth Report)

  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.

  Baseline to 3- and 9-month follow-up

• Change in Children's Depression Inventory - 2 (Parent Report)

  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.

  Baseline to 3- and 9-month follow-up

Secondary Outcomes (9)

• Change in Screen for Anxiety Related Disorders (Youth Report)

  Baseline to 3- and 9-month follow-up

• Change in Screen for Anxiety Related Disorders (Parent Report)

  Baseline to 3- and 9-month follow-up

• Change in Perceived Control Scale for Children

  Baseline to immediate post-intervention, 3-month, and 9-month follow-ups.

• Change in Secondary Control Scale for Children

  Baseline to immediate post-intervention, 3-month, and 9-month follow-ups.

• Change in UCLA Loneliness Scale

  Baseline to immediate post-intervention, 3-month, and 9-month follow-ups.

Other Outcomes (2)

• Change in Implicit Theories of Personality Questionnaire, parent-report

  Baseline to 3-month and 9-month follow-ups

• Change in Brief Symptom Inventory-18

  Baseline to 3-month and 9-month follow-ups

Study Arms (3)

PROJECT PERSONALITY

ACTIVE COMPARATOR

Behavioral: PROJECT PERSONALITY

VR PERSONALITY PROJECT

EXPERIMENTAL

Behavioral: VR PERSONALITY PROJECT

SHARING FEELINGS PROGRAM

PLACEBO COMPARATOR

Behavioral: SHARING FEELINGS PROGRAM

Interventions

PROJECT PERSONALITY BEHAVIORAL

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

Also known as: Web-based growth mindset intervention

PROJECT PERSONALITY

VR PERSONALITY PROJECT BEHAVIORAL

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.

Also known as: Virtual reality growth mindset intervention

VR PERSONALITY PROJECT

SHARING FEELINGS PROGRAM BEHAVIORAL

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.

Also known as: Web-based supportive therapy intervention

SHARING FEELINGS PROGRAM

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead
• Limbix Health, Inc.: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794-2500, United States

RECRUITING

Related Publications (1)

• Schleider JL, Mullarkey MC, Weisz JR. Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13368. doi: 10.2196/13368.

  PMID: 31290406 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jessica L Schleider, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica L Schleider, PhD

CONTACT

631-632-4131; jessica.schleider@stonybrook.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: March 20, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

US (1)