ClinicalTrials.gg
RecruitingNCT07661901DIGIRewardUpdated Aug 26, 2026

Reward Sensitivity Digital Intervention for Suicide Risk

An interventional study of Suicide prevention treatment in Suicidal Ideation, Suicidal and Suicidal Thoughts, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
13 Years to 17 Years
Sex
All
01

Study 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. 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.
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.

02

Conditions studied

  • Suicidal Ideation
  • Suicidal
  • Suicidal Thoughts
  • Digital Health Intervention
  • Reward Sensitivity
  • Anhedonia

Keywords

  • Adolescents
  • Legal Guardians
  • Digital
  • Philadelphia
  • Suicide
  • Intervention
  • Prevention
  • Dyads
  • Reward Sensitivity
  • Anhedonia
03

In context

Suicidal Ideation

569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.

This study's planned enrollment of 20 is below the median of 80 across 469 interventional studies indexed under Suicidal Ideation.

Browse Suicidal Ideation studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • BehavioralSuicide prevention treatment

    Digital just-in-time adaptive intervention to enhance reward sensitivity and reduce suicidal ideation

    Also known as: DIGIReward

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 (Focus Group)

  2. 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.

    Time frame: Day 1 (Focus Group)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jun 2027, 10 months after the start.

Of 281 non-industry interventional studies with no phase under Suicidal Ideation, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 10 months is below that.

Counting every sponsor, half of 290 studies reached it within 29 months; a quarter within 13 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2026
First posted
Jun 22, 2026
StartActual
Aug 21, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Sep 2027
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07661901
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Aug 21, 2026
Primary completion
Jun 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Sydney Lempert, B.A.
Contact
Sydney.Lempert@Pennmedicine.upenn.edu
215-746-3337
Marin Kautz, Ph.D.
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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