NCT07661901

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jun 2026Sep 2027

Study Start

First participant enrolled

June 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 2, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

AdolescentsLegal GuardiansDigitalPhiladelphiaSuicideInterventionPreventionDyadsReward SensitivityAnhedonia

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 1 (Focus Group)

Interventions

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

Also known as: DIGIReward

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Suicidal IdeationAnhedoniaSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marin Kautz, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 22, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations