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Идёт набор NCT06896071

Evaluating a Digital Single-session Intervention for Adolescent Mental Health in New Zealand

Без фазы С лечением Healthy

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: Project SOLVE, Project Success.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: 12 лет — 14 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
Новая Зеландия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Project SOLVE and Rangatahi in Aotearoa: Evaluating a Digital Single-Session Intervention for Adolescent Mental Health in New Zealand Through a School-based Randomised Controlled Trial

Обзор

Currently, one in five rangatahi (young people) in Aotearoa report difficulty accessing support for their mental health concerns. This treatment gap has prompted academics and clinicians to consider whether online and/or school-based interventions can increase access to evidence-based mental health care. This research is a randomised controlled trial to evaluate the effectiveness of Project SOLVE, an online problem-solving intervention, compared to Project Success, an activity that teaches young people study skills. Underdeveloped problem-solving skills have been associated with varying presentations of mental distress, including depression, hopelessness, and suicidal ideation. This association has meant problem solving is often featured as a core component of therapeutic interventions, and strengthening problem solving skills has been shown to improve clinical outcomes in youth who experience mental health concerns. For these reasons, the investigators hope that Project SOLVE will support the development of problem solving in rangatahi in Aotearoa and have a positive effect on their proximal and longitudinal mental health outcomes.

Вмешательства

  • Поведенческое Project SOLVE
    Project SOLVE is a 30-minute self-guided online activity that includes an introduction to problem solving and which types of problems might be most appropriate for this skill; a description of how the brain facilitates problem solving; vignettes demonstrating how older adolescents have solved their problems; scientific evidence that problem solving can work; practice exercises; and activities to encourage the use of problem solving in daily life. The intervention teaches students how to solve pr
  • Поведенческое Project Success
    Project Success is comparable to Project SOLVE in format and length (i.e., a 30 minute online, self-guided intervention) and teaches young people three strategies to reach their academic goals: how to take effective notes, how to break big assignments down into smaller tasks, and how to ask trusted others for help.

Первичные конечные точки

  • Internalising and externalising symptoms [Срок оценки: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention]
Вторичные конечные точки (6)
  • Social Problem Solving Skills [Срок оценки: Immediately pre-intervention and 12 weeks post-intervention]
  • General Self-Efficacy [Срок оценки: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention]
  • Hope [Срок оценки: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention]
  • Hopelessness [Срок оценки: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention]
  • Well-Being [Срок оценки: Immediately pre-intervention and 12 weeks post-intervention]
  • Educational Self-Efficacy [Срок оценки: Immediately pre-intervention, immediately post-intervention and 12 weeks post-intervention]

Критерии участия

Критерии включения

  • Any Year 9 student (ages 12-14 years old) at a participating school who provides assent.

Критерии исключения

  • Any Year 9 student (ages 12-14 years old) at a participating school who does not provide assent and/or whose parent/caregiver does not provided consent.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Новая Зеландия · 1 центр
  • St Peter's School Cambridge — Cambridge

Публикации

  • Fenwick-Smith A, Dahlberg EE, Thompson SC. Systematic review of resilience-enhancing, universal, primary school-based mental health promotion programs. BMC Psychol. 2018 Jul 5;6(1):30. doi: 10.1186/s40359-018-0242-3. PMID 29976252
  • Thabrew H, Stasiak K, Hetrick SE, Wong S, Huss JH, Merry SN. E-Health interventions for anxiety and depression in children and adolescents with long-term physical conditions. Cochrane Database Syst Rev. 2018 Aug 15;8(8):CD012489. doi: 10.1002/14651858.CD012489.pub2. PMID 30110718
  • Ludin N, Holt-Quick C, Hopkins S, Stasiak K, Hetrick S, Warren J, Cargo T. A Chatbot to Support Young People During the COVID-19 Pandemic in New Zealand: Evaluation of the Real-World Rollout of an Open Trial. J Med Internet Res. 2022 Nov 4;24(11):e38743. doi: 10.2196/38743. PMID 36219754
  • Sutcliffe K, Ball J, Clark TC, Archer D, Peiris-John R, Crengle S, Fleming TT. Rapid and unequal decline in adolescent mental health and well-being 2012-2019: Findings from New Zealand cross-sectional surveys. Aust N Z J Psychiatry. 2023 Feb;57(2):264-282. doi: 10.1177/00048674221138503. Epub 2022 Dec 1. PMID 36453262
  • Schleider JL, Weisz JR. Little Treatments, Promising Effects? Meta-Analysis of Single-Session Interventions for Youth Psychiatric Problems. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):107-115. doi: 10.1016/j.jaac.2016.11.007. Epub 2016 Nov 25. PMID 28117056
  • Schleider JL, Mullarkey MC, Fox KR, Dobias ML, Shroff A, Hart EA, Roulston CA. A randomized trial of online single-session interventions for adolescent depression during COVID-19. Nat Hum Behav. 2022 Feb;6(2):258-268. doi: 10.1038/s41562-021-01235-0. Epub 2021 Dec 9. PMID 34887544

Идентификаторы

NCT: NCT06896071 · HREC(Health)2024#60

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗