- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07539636
Virtual Intervention for Behavioral Health in Emerging Adults; "VIBE in the Parks" (VIBE)
April 20, 2026 updated by: University of Illinois at Chicago
Reaching Teens Where They Are: Integrating Digital Low-Intensity Mental Health Treatment Into Park District Teen Programming
The goal of this study is first to develop and adapt a digital low-intensity treatment, "VIBE in the Parks", for adolescents and young adults (AYA) who visit programming at the Chicago Park District.
A trial will occur at four Park District sites to compare how "VIBE in the Parks" works compared to a control condition (where AYA are given access to a digital workbook).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Amid an unprecedented youth mental health crisis, adolescents and young adults (AYA) have the most barriers to receiving mental healthcare.
While digital tools are a scalable and accessible way to provide timely mental health screening and referral options, these tools have failed to engage AYA in their daily lives.
This failure is driven by multiple factors, including a lack of: 1) understanding of implementation determinants for digital tools in community spaces; and 2) partnership with AYA, their caregivers, and support staff who work in key community settings where AYA spend their time.
The goal of this study is to target AYA engagement in the design and implementation of a digital low-intensity treatment for AYA in Chicago Park District (CPkD) Teen Programming.
The CPkD is the largest park district in the country, and more than 40,000 youth are served daily across all 77 Chicago neighborhoods.
This project harnesses on a partnership with CPkD and is grounded in the Accelerated Creation-to-Sustainment (ACTS) Model to guide the development of a technology ("VIBE in the Parks"), as well as its service and implementation plans for CPkD sites.
Aim 1 follows the first phase of the ACTS Model, Create.
Human-centered design and community-engaged research methodologies will be used to collaborate with the existing CPkD Youth Advisory Board and Teen Programming participants, caregivers of AYA served by CPkD, and CPkD staff.
Design activities will focus on targeting mechanisms that are believed to influence engagement: 1) individual-level barriers to care; 2) leveraging spaces where youth spend their time, including assessing determinants in these spaces; and 3) elevating key player input throughout design.
The products of Aim 1 will include: an initial version of "VIBE in the Parks" that demonstrates usability and acceptability by key players, a service protocol for integration of the "VIBE in the Parks" and potential higher clinical needs reported by AYA as a result of using the tool, and an implementation blueprint for integration into CPkD programming.
Additionally, extended usability testing will pilot all trial activities to be conducted in Aim 2. In Aim 2, the second phase of the ACTS Model, Trial, will be followed by conducting a pilot randomized controlled trial in CPkD sites using an Optimization, Effectiveness, and Implementation trial methodology.
The "VIBE in the Parks" will be compared to a control condition (digital workbook) across a pragmatic, rollout implementation trial.
Primary outcomes include acceptability and feasibility, along with reductions of individual levels to mental healthcare, DMH use, and, secondarily, clinical outcomes (anxiety, depression).
Optimization activities will occur across the trial period.
In sum, the naturalistic approach of this work addresses multiple barriers to real-world digital tool engagement failures for AYA.
It will provide key insights into engagement strategies, adaptations, and both service and implementation practices that will support AYA in community settings.
Study Type
Interventional
Enrollment (Estimated)
268
Phase
- Not Applicable
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
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Be a participant in Chicago Park District Teen Programming at a trial site
- Be between the ages of 13-24 years of age
- Be able to speak and read in English
Exclusion Criteria:
- Absence of the above criteria
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: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "VIBE in the Parks"
"VIBE in the Parks" developed across Aim 1 activities
|
"VIBE in the Parks" will be developed across Aim 1 activities and will include screening, feedback, and access to digital resources related to symptoms
|
|
Active Comparator: Digital Control
Access to a digital self-help book
|
Digital control will include providing participants access to a digital workbook for Cognitive Behavioral Therapy (CBT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
After Scenario Questionnaire
Time Frame: Administered three times; baseline, week 2, week 4
|
3-items; 7-point scale (i.e., 1-7), with higher scores indicating greater satisfaction; Assesses satisfaction
|
Administered three times; baseline, week 2, week 4
|
|
Kiddie Computerized Adaptive Tests, Anxiety and Depression Modules
Time Frame: Administered five times; baseline and at weeks 1, 2, 3, and 4
|
~1 minute to complete each self-report module, assess anxiety and depressive symptoms; Higher scores indicate greater symptom severity
|
Administered five times; baseline and at weeks 1, 2, 3, and 4
|
|
TeACH System Individual Barriers and Engagement Questionnaire
Time Frame: Administered 5 times, at baseline and weeks 1, 2, 3, 4
|
4-items; Mental Health Understanding, Confidence to Act, Likelihood to use DMH (5-point Likert Scale, higher scores indicate greater understanding, confidence, likelihood); DMH Use (Y/N/Unsure)
|
Administered 5 times, at baseline and weeks 1, 2, 3, 4
|
|
Twente Engagement with Ehealth Technologies Scale
Time Frame: Administered five times, at baseline and weeks 1, 2, 3, 4
|
9-items on a 5-point scale, with higher scores indicating stronger engagement; Engagement with e-health (behavior, cognition, affect)
|
Administered five times, at baseline and weeks 1, 2, 3, 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder-7
Time Frame: Administered twice, at baseline and week 4
|
7-items, 4-point scale (i.e., 0-3), with higher scores indicating more anxiety symptoms; Anxiety; Administered to ages 18+
|
Administered twice, at baseline and week 4
|
|
Patient Health Questionnaire-9
Time Frame: Administered twice, at baseline and week 4
|
9-items, 4-point scale (i.e., 0-3), with higher scores indicating more depressive symptoms; Depression; Administered to ages 18+
|
Administered twice, at baseline and week 4
|
|
Revised Children's Anxiety and Depression Scale
Time Frame: Administered twice, at baseline and week 4
|
25-items, 4-point scale (i.e., 0-3), with higher scores indicating more symptoms; Anxiety, Low Mood; Administered to ages 13-17, Parents when opted in
|
Administered twice, at baseline and week 4
|
|
Mental Health Implementation Science Tools - Consumer Version
Time Frame: Administered three times, at baseline, weeks 2 and 4
|
Assess mental health interventions by implementation domains on a 7-point Likert Scale, with higher scores indicating stronger agreement; subscales administered: Acceptability, Appropriateness, Accessibility/Reach
|
Administered three times, at baseline, weeks 2 and 4
|
|
Self-Stigma of Seeking Help Scale
Time Frame: Administered three times, at baseline, weeks 2 and 4
|
10-items, 5-point scale (i.e., 1-5), with higher scores indicating more agreement; feelings of stigma around receiving mental health care
|
Administered three times, at baseline, weeks 2 and 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WHO Disability Assessment Schedule 2.0
Time Frame: Administered once, at baseline
|
12-Items, 5-point scale (i.e., 0-4), with higher scores indicating more severity; health and disability; Administered to ages 18+
|
Administered once, at baseline
|
|
DSM-5 Cross-Cutting Symptom Measure
Time Frame: Administered once, at baseline
|
23 item (adult) or 25 item (child) self-report tool using a 5-point scale (i.e., 0-4), with scores reviewed by domain and not as a total sum; Assesses mental health
|
Administered once, at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Colleen Stiles-Shields, Ph.D., University of Illinois Chicago
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 (Estimated)
July 1, 2027
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
October 31, 2028
Study Registration Dates
First Submitted
April 13, 2026
First Submitted That Met QC Criteria
April 13, 2026
First Posted (Actual)
April 20, 2026
Study Record Updates
Last Update Posted (Actual)
April 23, 2026
Last Update Submitted That Met QC Criteria
April 20, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH140914 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD will be shared via the NIMH Data Archive (NDA): https://nda.nih.gov/
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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