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NCT Number: NCT07661901

Reward Sensitivity Digital Intervention for Suicide Risk

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Marin Kautz, Ph.D.

PRINCIPAL_INVESTIGATOR

Sydney Lempert, B.A.

CONTACT

[email protected]

215-746-3337

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suicide prevention treatment

Behavioral

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

Other names: DIGIReward

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sydney Lempert, B.A.

CONTACT

[email protected]

215-746-3337

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Pilot Development of a Youth-Focused Digital Just-in-Time Adaptive Intervention to Enhance Reward Sensitivity and Reduce Suicidal Ideation

Acronym: DIGIReward

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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