Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness

Официальное название

Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness: An RCT Examining Biopsychosocial Mechanisms

Обзор

Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country.

Подробное описание

Specific Aim 1. Using a dismantling randomized design, compare intervention conditions to determine those components essential for optimizing substance use and mental health: a) Strengths-Based Outreach and Advocacy (SBOA), b) Motivational Interviewing (MI)/Community Reinforcement Approach (CRA), c) SBOA+MI/CRA, and d) Services As Usual (SAU). Hypothesis. Youth assigned to SBOA+MI/CRA will show better short and long-term outcomes on Opioid Use Disorder prevention and on other substance use and mental health outcomes than youth assigned to either intervention alone or Services As Usual.

Specific Aim 2. Test whether intended change processes (social stability, psychosocial resources, stress) produce the desired change on substance use and mental health. Hypothesis. Inasmuch as the interventions trigger successful increases in social stability and psychosocial resources and reductions in stress, targeted outcomes will improve.

Specific Aim 3. Explore how the moderators of age, sex, race/ethnicity, sexual/gender minority status, and experience of childhood abuse and neglect influence intervention response.

Specific Aim 4. Determine cost effectiveness of the intervention approaches.

Вмешательства

• Поведенческое Motivational Interviewing/Community Reinforcement Approach (MI/CRA)
  MI/CRA includes two Motivational Interviewing sessions and twelve 1-hour Community Reinforcement Approach sessions.
• Поведенческое Strengths-Based Outreach and Advocacy (SBOA )
  The number of Strengths-Based Outreach and Advocacy sessions participants will receive are flexibly determined based upon youth needs.
• Поведенческое Services as Usual (SAU)
  Participants assigned to this group will receive the standard services provided to all youth involved with the drop-in center.

Первичные конечные точки

• Form 90 Substance Use interview [Срок оценки: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.]
• Shortened Inventory of Problems - Alcohol and Drugs (SIP-AD) [Срок оценки: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.]
• Presence of drugs of abuse [Срок оценки: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.]
• Beck Depression Inventory II (BDI-II) [Срок оценки: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.]
• Beck Anxiety Inventory (BAI) [Срок оценки: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.]
• Short Form-12 [Срок оценки: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.]

Критерии участия

Критерии включения

• Youth must meet the criteria for homelessness as defined by the McKinney-Vento Act: children and youth who lack a fixed, regular, and adequate nighttime residence; or live in a welfare hotel, or place without regular sleeping accommodations, or live in a shared residence with other persons due to the loss of one's housing or economic hardship
• Must speak english adequately to complete measures

Критерии исключения

• Youth who have a stable housing situation.
• Non-English speaker

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 · 2 центра

• Star House — Columbus
• Ohio State University — Columbus

Публикации

• Ford J, Slesnick N, Browning C, Feng X, Yilmazer T, Boettner B, Luthy J, Fitzpatrick M, Pinkus L, Holowacz E, Hang C. Building social and structural connections for the prevention of opioid use among youth experiencing homelessness: study protocol for a randomized controlled trial. BMC Public Health. 2026 Jul 15. doi: 10.1186/s12889-026-28177-4. Online ahead of print. PMID 42449276

Идентификаторы

NCT: NCT06311838 · 2023H0244

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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