Mental HealthTeACHNCT05466929
Engagement With Digital Mental Health (DMH) Technologies in Pediatric Primary Care
A study testing TeACH System Resources in people with Mental Health, run by Rush University Medical Center at 2 sites in United States.
Trial summary
The goal of this study is to use and adapt existing digital mental health technologies to advance the engagement, assessment, detection, treatment, and delivery of services for pediatric mental health in families from underserved communities. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Mental Health
- What is being tested?
- TeACH System Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2024to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Are receiving care at specified Rush University Health System and University of Illinois at Chicago Pediatric Primary Care locations
- Are between 13-17 years of age
- Are able to speak and read in English
- Symptoms of anxiety disorder
Who cannot join
- Absence of the above inclusion criteria.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois at Chicago
Chicago, Illinois, 60601
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Supporting Mental Health in Underserved Youth: Engagement With Digital Mental Health Technologies in Pediatric Primary Care
The goal of this study is to use and adapt existing digital mental health technologies to advance the engagement, assessment, detection, treatment, and delivery of services for pediatric mental health in families from underserved communities.
Read the detailed description
The goal of this study is to use and adapt existing digital mental health technologies to advance the engagement, assessment, detection, treatment, and delivery of services for pediatric mental health. Specifically, user-centered design methodologies and an implementation science framework will be used to guide the development and implementation of the Teen Assess, Check, and Heal (TeACH) System into a pediatric primary care clinic serving teens and families from underserved communities.
Study objectives include:
- Collaborating with underserved teens and their parents to identify strategies to target top barriers to engagement as well as top ethical concerns and requirements for cultural relevance, usability, and usefulness of the TeACH System (Phase 1)
- Refining the plan for implementing the TeACH System through observations, interviews, and co-design workshops with pediatric primary care pediatricians and staff (Phase 2), and
- Implementing the TeACH System into a primary care clinics and evaluating it in a randomized trial. (Phase 3)
The team will measure engagement outcomes and satisfaction with the TeACH System
- Conditions
- Mental Health
- Being tested
- TeACH System Resources
- Keywords
- Digital Mental Health Technology, Digital Mental Health, Mental Health Disorders, Mental Health Wellness
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeACH System ResourcesBehavioural
Patients who screen positive for anxiety will receive psychoeducation and mental health recommendations (e.g., evidence-based apps) selected for use with the TeACH System through a collaborative, stakeholder-engaged approach completed in phases 1 and 2 of this project.
| Study group | Role | What they receive |
|---|---|---|
| TeACH System Resources | Experimental | Patients who screen positive for anxiety will receive stakeholder-informed feedback and resources (i.e., psychoeducation and mental health recommendations). Receives: Behavioral: TeACH System Resources |
| Evidence-based Resources | No intervention | Patients who screen positive for anxiety will receive a link to a webpage providing psychoeducation about anxiety and possible treatment options. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Understanding: Baseline
1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-5; 1 being "Not at All" and 5 being "Completely"). Specifically: "I understand what anxiety is."
Measured: Administered following assent (in case of participant attrition through the interaction)
Anxiety Understanding: Post Interaction
1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-5; 1 being "Not at All" and 5 being "Completely"). Specifically: "I understand what anxiety is."
Measured: Administered immediately after receiving randomized feedback/resources
Anxiety Understanding: Maintenance
1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-5; 1 being "Not at All" and 5 being "Completely"). Specifically: "I understand what anxiety is."
Measured: Administered one week after interaction with TeACH System
Confidence to Act: Baseline
1 item (Likert Scale); We will ask participants to rate how confident they feel to take action to help their anxiety symptoms on a Likert scale (1-5; 1 being "Not at All" to 5 being "Completely"). Specifically: "I feel confident I can do something if I feel anxiety."
Measured: Administered following assent (in case of participant attrition through the interaction)
Confidence to Act: Post Interaction
1 item (Likert Scale); We will ask participants to rate how confident they feel to take action to help their anxiety symptoms on a Likert scale (1-5; 1 being "Not at All" to 5 being "Completely"). Specifically: "I feel confident I can do something if I feel anxiety."
Measured: Administered immediately after receiving randomized feedback/resources
Confidence to Act: Maintenance
1 item (Likert Scale); We will ask participants to rate how confident they feel to take action to help their anxiety symptoms on a Likert scale (1-5; 1 being "Not at All" to 5 being "Completely"). Specifically: "I feel confident I can do something if I feel anxiety."
Measured: Administered one week after interaction with TeACH System
Likelihood of using DMH for Anxiety: Baseline
1 item (Likert Scale); We will ask participants to rate how likely they are to use digital mental health tools for their anxiety on a Likert scale (1-5; 1 being "Never" to 5 being "Absolutely"). Specifically: "If I feel anxiety, I would use a digital tool to help (app, website, reel/video)."
Measured: Administered following assent (in case of participant attrition through the interaction)
Likelihood of using DMH for Anxiety: Post Interaction
1 item (Likert Scale); We will ask participants to rate how likely they are to use digital mental health tools for their anxiety on a Likert scale (1-5; 1 being "Never" to 5 being "Absolutely"). Specifically: "If I feel anxiety, I would use a digital tool to help (app, website, reel/video)."
Measured: Administered immediately after receiving randomized feedback/resources
Likelihood of using DMH for Anxiety: Maintenance
1 item (Likert Scale); We will ask participants to rate how likely they are to use digital mental health tools for their anxiety on a Likert scale (1-5; 1 being "Never" to 5 being "Absolutely"). Specifically: "If I feel anxiety, I would use a digital tool to help (app, website, reel/video)."
Measured: Administered one week after interaction with TeACH System
DMH use for Anxiety: Baseline
1 item (Yes/No/Unsure); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms. Specifically: "I have used a digital tool to help with anxiety (app, website, reel/video)."
Measured: Administered following assent (in case of participant attrition through the interaction)
DMH use for Anxiety: Post Interaction
1 item (Yes/No/Unsure); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms. Specifically: "I have used a digital tool to help with anxiety (app, website, reel/video)."
Measured: Administered immediately after receiving randomized feedback/resources
DMH use for Anxiety: Maintenance, Change in DMH Use Following TeACH System Interaction
1 item (Yes/No/Unsure); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms. Specifically: "I have used a digital tool to help with anxiety (app, website, reel/video)."
Measured: Administered one week after interaction with TeACH System
Enrollment
We will track the number of teens who use the TeACH System during implementation phases and will compare this to the number of teens who were eligible but did not use the system.
Measured: Through study completion, an average of once per year.
Secondary outcomes (3)
Kiddie-Computerized Adaptive Tests (K-CAT) Anxiety Module
<1 minute to complete; Uses item response theory to pull from a large question item bank to accurately diagnose anxiety symptom severity.
Measured: Administered immediately after initiating use of the TeACH System; teen participants complete only once.
After-Scenario Questionnaire (ASQ): Post Interaction
3-item tool with seven response options (1-Strongly Disagree to 7-Strongly Agree) to assess satisfaction
Measured: Administered immediately after receiving randomized feedback/resources from TeACH System
After-Scenario Questionnaire (ASQ): Maintenance
3-item tool with seven response options (1-Strongly Disagree to 7-Strongly Agree) to assess satisfaction
Measured: Administered one week after interaction with TeACH System
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start16 Jul 2024
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group (TeACH System psychoeducation and recommendations) and control group (evidence-based online educational materials)
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466929
- Sponsor's protocol ID
- K08MH125069
- Acronym
- TeACH
- Status last verified
- Nov 2025
- First submitted
- 14 Jul 2022
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stiles-Shields C, Bobadilla G, Reyes K, Gustafson EL, Lowther M, Smith DL, Frisbie C, Antognini C, Dyer G, MacCarthy R, Martinengo N, Morris G, Touranachun A, Wilkens KM, Julion WA, Karnik NS. Digital Mental Health Screening, Feedback, and Referral System for Teens With Socially Complex Needs: Protocol for a Randomized Controlled Trial Integrating the Teen Assess, Check, and Heal System into Pediatric Primary Care. JMIR Res Protoc. 2025 Feb 18;14:e65245. doi: 10.2196/65245.
PubMed 39965196
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Mental Health in Underserved Youth: Engagement With Digital Mental Health Technologies in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT05466929
- Acronym / sponsor ID
- TeACH / K08MH125069
- Conditions
- Mental Health
- Keywords
- Digital Mental Health Technology, Digital Mental Health, Mental Health Disorders, Mental Health Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 20 Jul 2022 (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 to use and adapt existing digital mental health technologies to advance the engagement, assessment, detection, treatment, and delivery of services for pediatric mental health in families from underserved communities.
Detailed description
The goal of this study is to use and adapt existing digital mental health technologies to advance the engagement, assessment, detection, treatment, and delivery of services for pediatric mental health. Specifically, user-centered design methodologies and an implementation science framework will be used to guide the development and implementation of the Teen Assess, Check, and Heal (TeACH) System into a pediatric primary care clinic serving teens and families from underserved communities.
Study objectives include:
- Collaborating with underserved teens and their parents to identify strategies to target top barriers to engagement as well as top ethical concerns and requirements for cultural relevance, usability, and usefulness of the TeACH System (Phase 1)
- Refining the plan for implementing the TeACH System through observations, interviews, and co-design workshops with pediatric primary care pediatricians and staff (Phase 2), and
- Implementing the TeACH System into a primary care clinics and evaluating it in a randomized trial. (Phase 3)
The team will measure engagement outcomes and satisfaction with the TeACH System
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group (TeACH System psychoeducation and recommendations) and control group (evidence-based online educational materials)
| Arm | Type | Receives |
|---|---|---|
| TeACH System Resources | Experimental | Behavioral: TeACH System ResourcesPatients who screen positive for anxiety will receive stakeholder-informed feedback and resources (i.e., psychoeducation and mental health recommendations). |
| Evidence-based Resources | No intervention | –Patients who screen positive for anxiety will receive a link to a webpage providing psychoeducation about anxiety and possible treatment options. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Are receiving care at specified Rush University Health System and University of Illinois at Chicago Pediatric Primary Care locations
- Are between 13-17 years of age
- Are able to speak and read in English
- Symptoms of anxiety disorder
Key exclusion criteria (1 listed)
- Absence of the above inclusion 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 |
|---|---|---|
| TeACH System ResourcesPatients who screen positive for anxiety will receive psychoeducation and mental health recommendations (e.g., evidence-based apps) selected for use with the TeACH System through a collaborative, stakeholder-engaged approach completed in phases 1 and 2 of this project. | Behavioural | TeACH System Resources |
Primary outcome
Anxiety Understanding: Baseline
Time frame: Administered following assent (in case of participant attrition through the interaction)
1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-5; 1 being "Not at All" and 5 being "Completely"). Specifically: "I understand what anxiety is."
Anxiety Understanding: Post Interaction
Time frame: Administered immediately after receiving randomized feedback/resources
1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-5; 1 being "Not at All" and 5 being "Completely"). Specifically: "I understand what anxiety is."
Anxiety Understanding: Maintenance
Time frame: Administered one week after interaction with TeACH System
1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-5; 1 being "Not at All" and 5 being "Completely"). Specifically: "I understand what anxiety is."
Confidence to Act: Baseline
Time frame: Administered following assent (in case of participant attrition through the interaction)
1 item (Likert Scale); We will ask participants to rate how confident they feel to take action to help their anxiety symptoms on a Likert scale (1-5; 1 being "Not at All" to 5 being "Completely"). Specifically: "I feel confident I can do something if I feel anxiety."
Confidence to Act: Post Interaction
Time frame: Administered immediately after receiving randomized feedback/resources
1 item (Likert Scale); We will ask participants to rate how confident they feel to take action to help their anxiety symptoms on a Likert scale (1-5; 1 being "Not at All" to 5 being "Completely"). Specifically: "I feel confident I can do something if I feel anxiety."
Confidence to Act: Maintenance
Time frame: Administered one week after interaction with TeACH System
1 item (Likert Scale); We will ask participants to rate how confident they feel to take action to help their anxiety symptoms on a Likert scale (1-5; 1 being "Not at All" to 5 being "Completely"). Specifically: "I feel confident I can do something if I feel anxiety."
Likelihood of using DMH for Anxiety: Baseline
Time frame: Administered following assent (in case of participant attrition through the interaction)
1 item (Likert Scale); We will ask participants to rate how likely they are to use digital mental health tools for their anxiety on a Likert scale (1-5; 1 being "Never" to 5 being "Absolutely"). Specifically: "If I feel anxiety, I would use a digital tool to help (app, website, reel/video)."
Likelihood of using DMH for Anxiety: Post Interaction
Time frame: Administered immediately after receiving randomized feedback/resources
1 item (Likert Scale); We will ask participants to rate how likely they are to use digital mental health tools for their anxiety on a Likert scale (1-5; 1 being "Never" to 5 being "Absolutely"). Specifically: "If I feel anxiety, I would use a digital tool to help (app, website, reel/video)."
Likelihood of using DMH for Anxiety: Maintenance
Time frame: Administered one week after interaction with TeACH System
1 item (Likert Scale); We will ask participants to rate how likely they are to use digital mental health tools for their anxiety on a Likert scale (1-5; 1 being "Never" to 5 being "Absolutely"). Specifically: "If I feel anxiety, I would use a digital tool to help (app, website, reel/video)."
DMH use for Anxiety: Baseline
Time frame: Administered following assent (in case of participant attrition through the interaction)
1 item (Yes/No/Unsure); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms. Specifically: "I have used a digital tool to help with anxiety (app, website, reel/video)."
DMH use for Anxiety: Post Interaction
Time frame: Administered immediately after receiving randomized feedback/resources
1 item (Yes/No/Unsure); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms. Specifically: "I have used a digital tool to help with anxiety (app, website, reel/video)."
DMH use for Anxiety: Maintenance, Change in DMH Use Following TeACH System Interaction
Time frame: Administered one week after interaction with TeACH System
1 item (Yes/No/Unsure); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms. Specifically: "I have used a digital tool to help with anxiety (app, website, reel/video)."
Enrollment
Time frame: Through study completion, an average of once per year.
We will track the number of teens who use the TeACH System during implementation phases and will compare this to the number of teens who were eligible but did not use the system.
3 secondary outcomes
Kiddie-Computerized Adaptive Tests (K-CAT) Anxiety Module
Time frame: Administered immediately after initiating use of the TeACH System; teen participants complete only once.
After-Scenario Questionnaire (ASQ): Post Interaction
Time frame: Administered immediately after receiving randomized feedback/resources from TeACH System
After-Scenario Questionnaire (ASQ): Maintenance
Time frame: Administered one week after interaction with TeACH System
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Derived from this study: PubMed 39965196Stiles-Shields C, Bobadilla G, Reyes K, Gustafson EL, Lowther M, Smith DL, Frisbie C, Antognini C, Dyer G, MacCarthy R, Martinengo N, Morris G, Touranachun A, Wilkens KM, Julion WA, Karnik NS. Digital Mental Health Screening, Feedback, and Referral System for Teens With Socially Complex Needs: Protocol for a Randomized Controlled Trial Integrating the Teen Assess, Check, and Heal System into Pediatric Primary Care. JMIR Res Protoc. 2025 Feb 18;14:e65245. doi: 10.2196/65245.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeACH System Resources in people with Mental Health, run by Rush University Medical Center at 2 sites in United States.
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 4 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: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety Understanding: Baseline (time frame: Administered following assent (in case of participant attrition through the interaction)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466929, which also lists 1 linked publication.
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 10 Nov 2025.