AnxietyVIBENCT07539636
Virtual Intervention for Behavioral Health in Emerging Adults; "VIBE in the Parks"
A study testing "VIBE in the Parks" in people with Anxiety and Depression, run by University of Illinois Chicago.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- "VIBE in the Parks"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2027to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Absence of the above criteria
About this study
Official title: 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).
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- "VIBE in the Parks", Digital Control
- Keywords
- Digital Intervention, Adolescents, Young Adults, Depression, Anxiety, Optimization, Park District
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"VIBE in the Parks"Behavioural
"VIBE in the Parks" will be developed across Aim 1 activities and will include screening, feedback, and access to digital resources related to symptoms
Digital ControlBehavioural
Digital control will include providing participants access to a digital workbook for Cognitive Behavioral Therapy (CBT)
| Study group | Role | What they receive |
|---|---|---|
| "VIBE in the Parks" | Experimental | "VIBE in the Parks" developed across Aim 1 activities Receives: Behavioral: "VIBE in the Parks" |
| Digital Control | Active comparator | Access to a digital self-help book Receives: Behavioral: Digital Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
After Scenario Questionnaire
3-items; 7-point scale (i.e., 1-7), with higher scores indicating greater satisfaction; Assesses satisfaction
Measured: Administered three times; baseline, week 2, week 4
Kiddie Computerized Adaptive Tests, Anxiety and Depression Modules
~1 minute to complete each self-report module, assess anxiety and depressive symptoms; Higher scores indicate greater symptom severity
Measured: Administered five times; baseline and at weeks 1, 2, 3, and 4
TeACH System Individual Barriers and Engagement Questionnaire
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)
Measured: Administered 5 times, at baseline and weeks 1, 2, 3, 4
Twente Engagement with Ehealth Technologies Scale
9-items on a 5-point scale, with higher scores indicating stronger engagement; Engagement with e-health (behavior, cognition, affect)
Measured: Administered five times, at baseline and weeks 1, 2, 3, 4
Secondary outcomes (5)
Generalized Anxiety Disorder-7
7-items, 4-point scale (i.e., 0-3), with higher scores indicating more anxiety symptoms; Anxiety; Administered to ages 18+
Measured: Administered twice, at baseline and week 4
Patient Health Questionnaire-9
9-items, 4-point scale (i.e., 0-3), with higher scores indicating more depressive symptoms; Depression; Administered to ages 18+
Measured: Administered twice, at baseline and week 4
Revised Children's Anxiety and Depression Scale
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
Measured: Administered twice, at baseline and week 4
Mental Health Implementation Science Tools - Consumer Version
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
Measured: Administered three times, at baseline, weeks 2 and 4
Self-Stigma of Seeking Help Scale
10-items, 5-point scale (i.e., 1-5), with higher scores indicating more agreement; feelings of stigma around receiving mental health care
Measured: Administered three times, at baseline, weeks 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Jul 2027 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A pilot randomized controlled trial will be conducted using an Optimization, Effectiveness, and Implementation (OEI) trial methodology. The "VIBE in the Parks" will be compared to a control condition across a pragmatic, rollout implementation trial design. Namely, different sites and activities for Teen Programming will be selected by simple randomization to first offer the control condition for two months, followed by the "VIBE in the Parks".
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colleen Stiles-Shields, Ph.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539636
- Sponsor's protocol ID
- R34MH140914
- Acronym
- VIBE
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared via the NIMH Data Archive (NDA): https://nda.nih.gov/
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Teens Where They Are: Integrating Digital Low-Intensity Mental Health Treatment Into Park District Teen Programming
- ClinicalTrials.gov ID
- NCT07539636
- Acronym / sponsor ID
- VIBE / R34MH140914
- Conditions
- Anxiety, Depression
- Keywords
- Digital Intervention, Adolescents, Young Adults, Depression, Anxiety, Optimization, Park District
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pilot randomized controlled trial will be conducted using an Optimization, Effectiveness, and Implementation (OEI) trial methodology. The "VIBE in the Parks" will be compared to a control condition across a pragmatic, rollout implementation trial design. Namely, different sites and activities for Teen Programming will be selected by simple randomization to first offer the control condition for two months, followed by the "VIBE in the Parks".
| Arm | Type | Receives |
|---|---|---|
| "VIBE in the Parks" | Experimental | Behavioral: "VIBE in the Parks""VIBE in the Parks" developed across Aim 1 activities |
| Digital Control | Active comparator | Behavioral: Digital ControlAccess to a digital self-help book |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Absence of the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "VIBE in the Parks""VIBE in the Parks" will be developed across Aim 1 activities and will include screening, feedback, and access to digital resources related to symptoms | Behavioural | "VIBE in the Parks" |
| Digital ControlDigital control will include providing participants access to a digital workbook for Cognitive Behavioral Therapy (CBT) | Behavioural | Digital Control |
Primary outcome
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
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
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)
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)
5 secondary outcomes
Generalized Anxiety Disorder-7
Time frame: Administered twice, at baseline and week 4
Patient Health Questionnaire-9
Time frame: Administered twice, at baseline and week 4
Revised Children's Anxiety and Depression Scale
Time frame: 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
Self-Stigma of Seeking Help Scale
Time frame: Administered three times, at baseline, weeks 2 and 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared via the NIMH Data Archive (NDA): https://nda.nih.gov/
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colleen Stiles-Shields, Ph.D. principal investigator
University of Illinois Chicago
Questions about this trial
What is this clinical trial studying?
A study testing "VIBE in the Parks" in people with Anxiety and Depression, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
After Scenario Questionnaire (time frame: Administered three times; baseline, week 2, week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.