NCT07539636

Brief 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. 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
16mo left

Started Jul 2027

Typical duration for not_applicable anxiety

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2027

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

April 13, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

Digital InterventionAdolescentsYoung AdultsDepressionAnxietyOptimizationPark District

Outcome Measures

Primary Outcomes (4)

  • After Scenario Questionnaire

    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

    \~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

    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

    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 Outcomes (5)

  • Generalized Anxiety Disorder-7

    Administered twice, at baseline and week 4

  • Patient Health Questionnaire-9

    Administered twice, at baseline and week 4

  • Revised Children's Anxiety and Depression Scale

    Administered twice, at baseline and week 4

  • Mental Health Implementation Science Tools - Consumer Version

    Administered three times, at baseline, weeks 2 and 4

  • Self-Stigma of Seeking Help Scale

    Administered three times, at baseline, weeks 2 and 4

Other Outcomes (2)

  • WHO Disability Assessment Schedule 2.0

    Administered once, at baseline

  • DSM-5 Cross-Cutting Symptom Measure

    Administered once, at baseline

Study Arms (2)

"VIBE in the Parks"

EXPERIMENTAL

"VIBE in the Parks" developed across Aim 1 activities

Behavioral: "VIBE in the Parks"

Digital Control

ACTIVE COMPARATOR

Access to a digital self-help book

Behavioral: Digital Control

Interventions

"VIBE in the Parks" will be developed across Aim 1 activities and will include screening, feedback, and access to digital resources related to symptoms

"VIBE in the Parks"
Digital ControlBEHAVIORAL

Digital control will include providing participants access to a digital workbook for Cognitive Behavioral Therapy (CBT)

Digital Control

Eligibility Criteria

Age13 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Absence of the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Colleen Stiles-Shields, Ph.D.

    University of Illinois Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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".
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

October 31, 2028

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

IPD will be shared via the NIMH Data Archive (NDA): https://nda.nih.gov/