Suicidal IdeationDIGIRewardNCT07661901
Reward Sensitivity Digital Intervention for Suicide Risk
A study testing Suicide prevention treatment in people with Suicidal Ideation and Suicidal, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this clinical trial is to develop and test an app designed to reduce suicide risk and improve emotional well-being in adolescents. The study will test if the app's daily check ins and recommended mood boosting skills will improve the adolescent's overall mood and suicidality. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicidal Ideation, Suicidal, Suicidal Thoughts
- What is being tested?
- Suicide prevention treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2026to Sep 2027
- 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
- ADOLESCENTS
- Aged 13-17 years old
- Recent suicidal ideation
- Access to a smartphone device
- Residing in the Philadelphia metropolitan area
- LEGALGUARDIANS
- They are the legal guardian of an adolescent that meets all study criteria (see above)
- They can read, write, and speak English
Who cannot join
- ADOLESCENTS
- Psychotic disorder, including schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified, with a past year psychotic episode prior to baseline
- Bipolar disorder I diagnosis, with a past year manic episode prior to baseline
- Imminent suicide risk (e.g., active suicidal ideation with a specific plan and intent)
- LEGALGUARDIANS
- There are no exclusion criteria for legal guardians
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Sydney Lempert, B.A., 215-746-3337, Sydney.Lempert@Pennmedicine.upenn.edu
Marin Kautz, Ph.D.
About this study
Official title: Pilot Development of a Youth-Focused Digital Just-in-Time Adaptive Intervention to Enhance Reward Sensitivity and Reduce Suicidal Ideation
The goal of this clinical trial is to develop and test an app designed to reduce suicide risk and improve emotional well-being in adolescents. The study will test if the app's daily check ins and recommended mood boosting skills will improve the adolescent's overall mood and suicidality. The main question it aims to answer is:
- Is the app practical and acceptable to use daily?
Read more
In the study, adolescents will:
- Participate in a focus group with other adolescents and provide feedback on the app itself (design, ease of use, etc.).
- Complete surveys and assessments on their mood, thoughts, and experiences.
- Complete assessments about their app experience.
In the study, the legal guardian of the adolescent will:
- Participate in a focus group with other adolescents and provide feedback on the app itself (design, ease of use, etc.).
- Complete assessments about their app experience.
Read the detailed description
Adolescent suicide remains a major concern, and current treatments and prevention approaches are not effective for all adolescents. Some adolescents, particularly those who have difficulty experiencing pleasure or positive emotions (anhedonia), may be at increased risk for suicidal thoughts and may benefit less from existing interventions. This study aims to address this gap by developing and testing a digital intervention designed to improve reward sensitivity, increase positive emotions, and reduce suicidal thoughts in adolescents.
The intervention uses a just-in-time adaptive intervention approach, meaning that participants receive brief support activities and coping tools on their smartphone throughout the day. These activities are designed to promote healthy reward-seeking behaviors, improve mood, and provide support during moments when adolescents may be especially open to intervention. The study also uses ecological momentary assessments, which are short real-time surveys completed multiple times per day to measure mood, motivation, thoughts, context, and daily experiences.
The study will be conducted in multiple phases. The study is currently recruiting for Phase 1. In Phase 1, adolescents and their legal guardians will participate in a co-design process and provide feedback on the digital platform and intervention content to improve usability and acceptability.
Participants will complete interviews, questionnaires, and digital assessments related to mood, emotions, reward sensitivity, coping behaviors, and suicidal thoughts. Findings from this study will help inform future digital suicide prevention interventions for adolescents.
- Conditions
- Suicidal Ideation, Suicidal, Suicidal Thoughts, Digital Health Intervention, Reward Sensitivity, Anhedonia
- Being tested
- Suicide prevention treatment
- Keywords
- Adolescents, Legal Guardians, Digital, Philadelphia, Suicide, Intervention, Prevention, Dyads, Reward Sensitivity, Anhedonia
- Medical subject headings
- Suicidal Ideation, Anhedonia, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide prevention treatmentBehavioural
Also called DIGIReward
Digital just-in-time adaptive intervention to enhance reward sensitivity and reduce suicidal ideation
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Digital Suicide Prevention Intervention
At least 80% of youth will report in qualitative feedback that the digital suicide prevention intervention is helpful and relevant to their daily lives.
Measured: Day 1 (Focus Group)
Usability of Digital Suicide Prevention Intervention
The digital suicide prevention intervention prototype will exceed established usability benchmarks, as measured by the System Usability Scale (SUS; range = 0-100, with higher scores indicating greater perceived usability), with a mean SUS score of at least 70.
Measured: Day 1 (Focus Group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start21 Aug 2026
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marin Kautz, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661901
- Sponsor's protocol ID
- 45392554 (26-0255)
- Acronym
- DIGIReward
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Development of a Youth-Focused Digital Just-in-Time Adaptive Intervention to Enhance Reward Sensitivity and Reduce Suicidal Ideation
- ClinicalTrials.gov ID
- NCT07661901
- Acronym / sponsor ID
- DIGIReward / 45392554 (26-0255)
- Conditions
- Suicidal Ideation, Suicidal, Suicidal Thoughts, Digital Health Intervention, Reward Sensitivity, Anhedonia
- Keywords
- Adolescents, Legal Guardians, Digital, Philadelphia, Suicide, Intervention, Prevention, Dyads
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Jun 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 clinical trial is to develop and test an app designed to reduce suicide risk and improve emotional well-being in adolescents. The study will test if the app's daily check ins and recommended mood boosting skills will improve the adolescent's overall mood and suicidality. The main question it aims to answer is:
- Is the app practical and acceptable to use daily?
In the study, adolescents will:
- Participate in a focus group with other adolescents and provide feedback on the app itself (design, ease of use, etc.).
- Complete surveys and assessments on their mood, thoughts, and experiences.
- Complete assessments about their app experience.
In the study, the legal guardian of the adolescent will:
- Participate in a focus group with other adolescents and provide feedback on the app itself (design, ease of use, etc.).
- Complete assessments about their app experience.
Detailed description
Adolescent suicide remains a major concern, and current treatments and prevention approaches are not effective for all adolescents. Some adolescents, particularly those who have difficulty experiencing pleasure or positive emotions (anhedonia), may be at increased risk for suicidal thoughts and may benefit less from existing interventions. This study aims to address this gap by developing and testing a digital intervention designed to improve reward sensitivity, increase positive emotions, and reduce suicidal thoughts in adolescents.
The intervention uses a just-in-time adaptive intervention approach, meaning that participants receive brief support activities and coping tools on their smartphone throughout the day. These activities are designed to promote healthy reward-seeking behaviors, improve mood, and provide support during moments when adolescents may be especially open to intervention. The study also uses ecological momentary assessments, which are short real-time surveys completed multiple times per day to measure mood, motivation, thoughts, context, and daily experiences.
The study will be conducted in multiple phases. The study is currently recruiting for Phase 1. In Phase 1, adolescents and their legal guardians will participate in a co-design process and provide feedback on the digital platform and intervention content to improve usability and acceptability.
Participants will complete interviews, questionnaires, and digital assessments related to mood, emotions, reward sensitivity, coping behaviors, and suicidal thoughts. Findings from this study will help inform future digital suicide prevention interventions for adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- ADOLESCENTS
- Aged 13-17 years old
- Recent suicidal ideation
- Access to a smartphone device
- Residing in the Philadelphia metropolitan area
Key exclusion criteria (6 listed)
- ADOLESCENTS
- Psychotic disorder, including schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified, with a past year psychotic episode prior to baseline
- Bipolar disorder I diagnosis, with a past year manic episode prior to baseline
- Imminent suicide risk (e.g., active suicidal ideation with a specific plan and intent)
- LEGALGUARDIANS
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 |
|---|---|---|
| Suicide prevention treatmentAlso: DIGIRewardDigital just-in-time adaptive intervention to enhance reward sensitivity and reduce suicidal ideation | Behavioural | – |
Primary outcome
Acceptability of Digital Suicide Prevention Intervention
Time frame: Day 1 (Focus Group)
At least 80% of youth will report in qualitative feedback that the digital suicide prevention intervention is helpful and relevant to their daily lives.
Usability of Digital Suicide Prevention Intervention
Time frame: Day 1 (Focus Group)
The digital suicide prevention intervention prototype will exceed established usability benchmarks, as measured by the System Usability Scale (SUS; range = 0-100, with higher scores indicating greater perceived usability), with a mean SUS score of at least 70.
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 26 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Marin Kautz, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suicide prevention treatment in people with Suicidal Ideation and Suicidal, run by University of Pennsylvania at 1 site 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Sydney Lempert, B.A. (215-746-3337, Sydney.Lempert@Pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Digital Suicide Prevention Intervention (time frame: Day 1 (Focus Group)). The study lists 2 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 26 Aug 2026.