Suicidal IdeasTEEN LENS EDNCT07916792
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department.
A study testing TEEN LENS in people with Suicidal Ideas and Suicidal Ideation, run by University of Colorado, Denver.
Trial summary
The purpose of this study is to test whether a lethal means safety planning intervention, TEEN LENS ED, is acceptable to teens at elevated suicide risk and their caregivers in the Emergency Department. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicidal Ideas, Suicidal Ideation, Suicidal Thoughts
- What is being tested?
- TEEN LENS
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 19 Nov 2026to 1 Mar 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Teens (13-17 years old) presenting to the Children's Hospital Colorado Emergency Department (ED) with a non-mental health related complaint, and with a non-acute positive suicide screen (using the validated Ask Suicide Screening Questions questionnaire).
- For inclusion, participants must be:
- English speaking as the first prototype of the tool was developed in English.
- 13 to <18 years old.
- Caregivers of teens 13-17 years old meeting the above criteria. Caregivers must be 18 years old or greater.
- Healthcare providers (physicians and/ or advanced practice providers) who care for teens meeting above criteria in the pediatric ED.
Who cannot join
- they are clinically unstable;
- they have altered mental status;
- they are not developmentally able to consent to participation;
- Current presentation for SI or other mental health concern.
- The provider has not discussed screening results with the teen and their legal guardian or the legal guardian is not at bedside.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: TEEN LENS ED: TEen ENgaged LEthal MeaNs Safety for the Emergency Department
The purpose of this study is to test whether a lethal means safety planning intervention, TEEN LENS ED, is acceptable to teens at elevated suicide risk and their caregivers in the Emergency Department.
- Conditions
- Suicidal Ideas, Suicidal Ideation, Suicidal Thoughts, Firearm Safety
- Being tested
- TEEN LENS, Usual Care
- Keywords
- Lethal means safety, Firearm storage, Firearm counseling
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEEN LENSBehavioural
Single tablet-based intervention to support lethal means safety planning.
Usual CareBehavioural
Standard list of mental health resources and crisis phone numbers.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants will receive a list of mental health resources in the Emergency Department prior to discharge. Receives: Behavioral: Usual Care |
| TEEN LENS | Experimental | Participants will receive a tablet-based lethal means safety planning intervention (TEEN LENS) and a list of mental health resources in the Emergency Department prior to discharge. Receives: Behavioral: TEEN LENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability among teens
Acceptability among teens during the intervention versus control period using the composite score from the adapted validated Client Satisfaction Questionnaire (CSQ-8), where higher scores indicate increased acceptability.
Measured: Within 48 hours of receipt of care (intervention or control).
Secondary outcomes (5)
Acceptability among caregivers
Acceptability among caregivers during the intervention versus control period using the composite score from the adapted validated Client Satisfaction Questionnaire (CSQ-8), where higher scores indicate increased acceptability.
Measured: Within 48 hours of receipt of care (intervention or control).
Provider perceived acceptability
Provider perceived acceptability of using TEEN LENS ED using the validated Acceptability of Intervention Measure (AIM), a composite score where higher scores indicate higher acceptability.
Measured: From start of the intervention period until end of the intervention period (6 months).
Provider perceived appropriateness
Provider perceived appropriateness using the validated Intervention Appropriateness Measure (IAM), a composite score where higher scores indicate higher appropriateness.
Measured: From start of the intervention period until end of the intervention period (6 months).
Provider perceived feasibility
Provider perceived feasibility using the validated Feasibility of Intervention Measure (FIM), a composite score where higher scores indicate higher feasibility.
Measured: From start of the intervention period until end of the intervention period (6 months).
Feasibility of follow up
Proportion of participants who complete baseline surveys that complete follow up.
Measured: From enrollment to follow up at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start19 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeasStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pre-post study design.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Maya Haasz, MD MSCS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916792
- Sponsor's protocol ID
- 22-2007
- Other IDs
- K23HD114903
- Acronym
- TEEN LENS ED
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared after removing any data that may be identifying.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEEN LENS ED: TEen ENgaged LEthal MeaNs Safety for the Emergency Department
- ClinicalTrials.gov ID
- NCT07916792
- Acronym / sponsor ID
- TEEN LENS ED / 22-2007
- Conditions
- Suicidal Ideas, Suicidal Ideation, Suicidal Thoughts, Firearm Safety
- Keywords
- Lethal means safety, Firearm storage, Firearm counseling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 19 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 4 Nov 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 purpose of this study is to test whether a lethal means safety planning intervention, TEEN LENS ED, is acceptable to teens at elevated suicide risk and their caregivers in the Emergency Department.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-post study design.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareParticipants will receive a list of mental health resources in the Emergency Department prior to discharge. |
| TEEN LENS | Experimental | Behavioral: TEEN LENSParticipants will receive a tablet-based lethal means safety planning intervention (TEEN LENS) and a list of mental health resources in the Emergency Department prior to discharge. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Teens (13-17 years old) presenting to the Children's Hospital Colorado Emergency Department (ED) with a non-mental health related complaint, and with a non-acute positive suicide screen (using the validated Ask Suicide Screening Questions questionnaire).
- Caregivers of teens 13-17 years old meeting the above criteria. Caregivers must be 18 years old or greater.
- Healthcare providers (physicians and/ or advanced practice providers) who care for teens meeting above criteria in the pediatric ED.
Key exclusion criteria (5 listed)
- they are clinically unstable;
- they have altered mental status;
- they are not developmentally able to consent to participation;
- Current presentation for SI or other mental health concern.
- The provider has not discussed screening results with the teen and their legal guardian or the legal guardian is not at bedside.
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 |
|---|---|---|
| TEEN LENSSingle tablet-based intervention to support lethal means safety planning. | Behavioural | TEEN LENS |
| Usual CareStandard list of mental health resources and crisis phone numbers. | Behavioural | Usual Care |
Primary outcome
Acceptability among teens
Time frame: Within 48 hours of receipt of care (intervention or control).
Acceptability among teens during the intervention versus control period using the composite score from the adapted validated Client Satisfaction Questionnaire (CSQ-8), where higher scores indicate increased acceptability.
5 secondary outcomes
Acceptability among caregivers
Time frame: Within 48 hours of receipt of care (intervention or control).
Provider perceived acceptability
Time frame: From start of the intervention period until end of the intervention period (6 months).
Provider perceived appropriateness
Time frame: From start of the intervention period until end of the intervention period (6 months).
Provider perceived feasibility
Time frame: From start of the intervention period until end of the intervention period (6 months).
Feasibility of follow up
Time frame: From enrollment to follow up at 2 months.
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 4 Nov 2026.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared after removing any data that may be identifying.
Related trials for Suicidal Ideas
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Exploratory Analysis of Interpersonal and Intrapersonal Psychological Processes Implied in Risk-taking and Suicidal Behaviors, in Adult and Adolescent At-risk
Suicidal Ideas, Suicidal Ideation
Recruiting
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
Major Depressive Disorder, Suicidal Ideas
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Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
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Couple-Based Crisis Safety Planning
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Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Subcutaneous Ketamine in the Treatment of Depressive Episode With Suicidal Ideation and/or Behavior in Adolescents
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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.
Maya Haasz, MD MSCS principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing TEEN LENS in people with Suicidal Ideas and Suicidal Ideation, run by University of Colorado, Denver.
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 6 inclusion and 5 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 4 Nov 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?
Contact Jenna Jordan (720-478-9218, jenna.jordan@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability among teens (time frame: Within 48 hours of receipt of care (intervention or control).). 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 4 Nov 2026.