Family Spirit Strengths

Обзор

This project addresses the disproportionate morbidity and mortality associated with mental and behavioral health problems in American Indian and Alaska Native communities. Access to culturally competent and effective behavioral health services is limited in many of these communities. The investigators aim to address this gap by testing the effectiveness of a trans-diagnostic secondary prevention program, Family Spirit Strengths (FSS) that can be embedded within home visiting services. The FSS program is a skills-based program that incorporates elements of evidence-based practice, the Common Elements Treatment Approach (CETA), and materials informed and developed based on an Indigenous advisory group. The FSS program aims to help participants build self-efficacy and coping skills, as well as build stronger connections to others, the participants' community, and cultural resources. The investigators will use a randomized controlled trial, whereby half of the participants will receive FSS and the other half will receive an evidence-based nutrition education program. The investigators' study is grounded in participatory processes and led by a team of Indigenous and allied researchers.

Вмешательства

• Поведенческое Family Spirit Strengths (FSS)
  The FSS intervention consists of psychoeducational components that emphasize the importance of mental and emotional health as part of overall wellness, and seek to normalize experiences of stress, to de-stigmatize help-seeking, and to build hope. Core content focuses on awareness of the connections between thoughts, feelings, behaviors, and spirituality, and imparts related self-help skills. It also specifically builds in connection to culture, land and others as coping strategies. The FSS lesso
• Поведенческое Family Spirit Nurture
  The active control Family Spirit Nurture, is an evidence-based nutrition education curriculum that has been previously tested with Navajo communities which focuses on age-appropriate parental feeding practices, including snack routines, avoidance of sugar-sweetened beverages (SSB) and promotion of water consumption.

Первичные конечные точки

• Difference in number of poor mental health days in last 30 days as assessed by a single item on the Health-Related Quality of Life (HRQOL) measure [Срок оценки: baseline, 3-4 months post baseline, 6-8 months post baseline]

Вторичные конечные точки (3)

• Change in Substance Use as measure by the Timeline Follow Back for Substance Use [Срок оценки: baseline, 3-4 months post baseline, 6-8 months post baseline]
• Change in depressive symptoms as measured by the Centers for Epidemiological Research Revised 10 item scale (CESDR-10) [Срок оценки: baseline, 3-4 months post baseline, 6-8 months post baseline]
• Change in anxiety symptoms as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form [Срок оценки: baseline, 3-6 months post baseline, 6-8 months post baseline]

Критерии участия

Критерии включения

• Self-identify as female; and
• Pregnant or be a primary caregiver of a child that is 24 months or younger; and
• 14 years or older at time of enrollment; and
• Report a family history of high-risk substance use and/or report high-risk levels of personal substance use; and
• Have elevated symptoms of depression and/or anxiety and/or risk of substance use disorder; and
• Be part of the service population of one of the participating sites.

Критерии исключения

• Profound disability that limits the ability to participate in assessments or interventions; and
• Unlikely to be residing in or near the research service area for the next 6 months.

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

Открытое

Основная цель

Профилактика

Центры проведения

США · 3 центра

• Johns Hopkins Center for Indigenous Health — Chinle
• Pokagon Health Services — Pokagon
• Johns Hopkins Center For Indigenous Health — Shiprock

Публикации

• Nelson L, Lopez LM, Archuleta S, Van Wyk SS, Kushman E, Martin L, Mitchell K, Leffler E, Werwie TR, Kemp CG, Cuddy RF, Haroz EE. Testing the effectiveness of Family Spirit Strengths (FSS) - a culturally informed intervention designed to prevent mental health and substance misuse for indigenous families through home visiting. BMC Public Health. 2026 Feb 26;26(1):1085. doi: 10.1186/s12889-026-26593- PMID 41749230

Идентификаторы

NCT: NCT05836090 · IRB00023017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗