Reward Sensitivity Digital Intervention for Suicide Risk (DIGIReward)

June 16, 2026 updated by: University of Pennsylvania

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?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 (Focus Group)
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.
Day 1 (Focus Group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Marin Kautz, Ph.D., University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45392554 (26-0255)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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