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Recruiting NCT07661901

Reward Sensitivity Digital Intervention for Suicide Risk

No phase Interventional Suicidal Ideation Suicidal Suicidal Thoughts Digital Health Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Suicide prevention treatment.
Who it may be relevant to
Registry conditions: Suicidal Ideation, Suicidal, Suicidal Thoughts, Digital Health Intervention. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Suicide prevention treatment
    Digital just-in-time adaptive intervention to enhance reward sensitivity and reduce suicidal ideation

Primary outcome measures

  • Acceptability of Digital Suicide Prevention Intervention [Time frame: Day 1 (Focus Group)]
  • Usability of Digital Suicide Prevention Intervention [Time frame: Day 1 (Focus Group)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT07661901 · 45392554 (26-0255)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗