Skills to Enhance Positivity in Suicidal Youth

Официальное название

Skills to Enhance Positivity in Adolescents at Risk for Suicide

Обзор

This is a Hybrid Type I Effectiveness-Implementation design. Specifically, this study proposes to test the effectiveness of STEP in reducing suicidal events and ideation in 216 adolescents, admitted to inpatient psychiatric care due to suicide risk. Participants will be randomized to either STEP or ETAU. STEP involves 4 in-person sessions (3 individual, 1 family) focused on psychoeducation regarding positive and negative affect, mindfulness meditation, gratitude, and savoring. Mood monitoring prompts and skill reminders will be sent daily for the first month post-discharge and three times a week for the following two months. The ETAU condition will receive reminders to log into a safety resource app, matched in frequency to the STEP group. Effectiveness aspects of the design include using clinical staff as interventionists and having very few exclusion criteria.

Подробное описание

216 participants and their families (across two sites) will be randomized to either STEP or ETAU (as described in the research strategy). Aims and hypotheses are below:

Aim 1: Examine the effectiveness of STEP in reducing suicidal events (attempt or emergency intervention to intercede attempt), active SI (with intent or plan), and depression at 6-month f/u (primary) and suicidal events at 12-month follow-up (f/u). H1: It is hypothesized that those randomized to STEP, compared to ETAU, will have lower rates of suicide events (H1A), active SI (H1B), and depression (H1C) over the 6-month follow-up period; H1D: It is hypothesized that those randomized to STEP, compared to ETAU, will have lower rates of suicidal events at the 12-month, long term f/u.

Aim 2: Examine engagement of the hypothesized mechanisms at the 3- and 6-month f/u. It is hypothesized that those randomized to STEP, compared to ETAU, will have: H2A: higher attention to positive affect, assessed by implicit tasks; H2B: higher gratitude and satisfaction with life, assessed by self-report; H2C: lower negative affect, assessed by implicit tasks and self-report.

Aim 3: Examine whether hypothesized mechanisms mediate reduction of suicidal events and ideation. H3: Changes in attention to positive affect, gratitude, satisfaction with life, and negative affect at 3-month f/u will be related to improvements in suicidal ideation and suicidal events at the 6-month f/u.

Secondary Aim Examine elements supporting external validity. Acceptability, appropriateness, and feasibility of STEP to patients, parents, clinicians, and administrators will be assessed by: 1) a survey consisting of brief, standardized measures of these items, and 2) qualitative interviews to further explore these perceptions. These findings will be used to: 1) modify STEP to address potential barriers, and 2) develop implementation strategies designed to overcome these challenges, for testing in a future Hybrid Type III effectiveness-implementation trial.

Вмешательства

• Поведенческое STEP
  Behavioral intervention to increase positive affect
• Поведенческое Enhanced TAU
  Standard care plus a phone app with a personalized safety plan

Первичные конечные точки

• Suicidal events [Срок оценки: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up]
• Suicidal ideation [Срок оценки: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up]
• Proportion of Weeks with Suicidal ideation [Срок оценки: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up]
• Depression [Срок оценки: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up]

Вторичные конечные точки (5)

• Attention to positive affect [Срок оценки: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up]
• Implicit positive and negative affect [Срок оценки: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up]
• Explicit positive and negative affect [Срок оценки: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up]
• Gratitude [Срок оценки: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up]
• Satisfaction with life scale [Срок оценки: baseline; change from baseline at 3 months, 6 months, and 12 months follow-up]

Критерии участия

Inclusion Criteria: Patients

• Ages 12- 60 years
• hospitalized on an inpatient psychiatric unit due to suicide risk
• past month suicide attempts or suicidal ideation
• proficient in English (parent either English or Spanish
• access to a smart phone.

Inclusion Criteria: Stakeholders

Ages 22 - 60 years

• work with adolescents hospitalized on an inpatient psychiatric unit due to suicide risk
• proficient in English or Spanish

Критерии исключения

• active psychotic disorder
• significant cognitive impairment or deficits
• ward of the State
• discharge to residential facility.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Children's Hospital — Boston
• Butler Hospital — Providence
• Bradley Hospital — Riverside

Публикации

• Yen S, Suazo N, Doerr J, Macrynikola N, Villarreal LS, Sodano S, O'Brien KHM, Wolff JC, Breault C, Gibb BE, Elwy R, Kahler CW, Ranney M, Jones R, Spirito A. Skills to Enhance Positivity in adolescents at risk for suicide: Protocol for a randomized controlled trial. PLoS One. 2023 Oct 20;18(10):e0287285. doi: 10.1371/journal.pone.0287285. eCollection 2023. PMID 37862324

Идентификаторы

NCT: NCT04994873 · 1023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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