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Идёт набор NCT07661901

Reward Sensitivity Digital Intervention for Suicide Risk

Без фазы С лечением Suicidal Ideation Suicidal Suicidal Thoughts Digital Health Intervention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Suicide prevention treatment.
Кому может быть актуально
Состояния в реестре: Suicidal Ideation, Suicidal, Suicidal Thoughts, Digital Health Intervention. Базовые параметры: 13 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT07661901 · 45392554 (26-0255)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗