- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02140359
Enhancing Housing First Programs With a Social Network Substance Use Intervention
2017. november 21. frissítette: David Kennedy, RAND
Housing First programs are promising approaches to transitioning substance using chronically homeless adults to affordable housing.
However, Housing First programs need to provide support to residents to adjust to their changing social environments.
The proposed project fulfills a critical gap by developing an electronic tool for a social network intervention using motivational interviewing techniques as well as results of a pilot test of the tool.
The hypothesis to be tested is that Housing First residents who are given the intervention will be significantly more motivated to change their drinking, drug use, sexual risk behaviors, and social networks compared to controls receiving usual care.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
We propose a 3-year study to develop and pilot test a social network substance use and HIV-risk intervention for permanent supportive housing program residents in the Skid Row area of Los Angeles.
The intervention will be developed for residents at the Skid Row Housing Trust (SRHT), one of the largest Housing First providers in Los Angeles.
Housing First residents are not required to abstain from alcohol and drugs as a requirement of their residency.
There is some evidence that providing housing rapidly to chronically homeless persons--along with support--helps to reduce substance use and HIV risk behaviors in the short term because homelessness is the primary cause of high-risk behavior.
However, the evidence thus far is limited.
One aspect that has not received much research attention is the needs of Housing First residents for support to transition their social networks while transitioning out of homeless into residency in a Housing First program.
New residents are exposed to a wide range of potentially negative social influences while also having greater potential to reconnect with lost positive ties.
This project will develop a social network intervention to residents of SRHT in order to increase their knowledge about their social networks and enhance their motivation to make necessary changes to improve their ability to reduce or continue to abstain from high-risk behavior.
The intervention sessions will enhance the weekly support meetings that SRHT case workers already conduct with new residents during their first 6 months of residency.
Case workers will be trained to deliver the 30-minute intervention sessions using a motivational interviewing style.
The intervention will be developed so that case managers can deliver it with the aid of an electronic tablet device.
The tablet will guide them in collecting information about the residents' social networks and then display several diagrams highlighting various aspects of the residents' networks.
They will then use motivational interviewing techniques to guide residents to think about how their network currently functions, how they would like it to function, and what steps they can take to make changes necessary to achieve goals related to reducing their substance use and sexual risk behaviors.
The intervention will be delivered by case managers across four sessions (at baseline and at two-week intervals).
We anticipate that residents who participate in this intervention will develop new strategies in their interactions with their social networks that will facilitate a reduction in their high-risk behavior.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
50
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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California
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Los Angeles, California, Egyesült Államok, 90021
- Skid Row Housing Trust
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Santa Monica, California, Egyesült Államok, 90407
- RAND Corporation
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Összes
Leírás
Inclusion Criteria:
- New residents of Skid Row Housing Trust receiving permanent supportive housing
Exclusion Criteria:
- Age younger than 18
- Does not speak English
- Cognitively impaired either by identifying those having a diagnosis of dementia in the new resident intake interview or using the Short Blessed Scale Exam)
- Does not screen positive for past -year harmful AOD use using the AUDIT-C (a score > 4 for men and > 3 for women) and DAST (a score greater than 2).
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Nincs beavatkozás: Control Group: Usual Care
Residents of a housing first permanent supporting housing program will be randomly assigned to this arm after screening and baseline assessments.
They will meet with case managers according to the usual procedures for new residents and will be given a standard case manager interaction.
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Kísérleti: Motivational Network Interview Recipients
Residents of a housing first permanent supporting housing program will be randomly assigned to this arm after screening and baseline assessments.
They will meet roughly every two weeks with a case manager and answer questions about their social network, will be shown visual feedback about their networks, and will participate in a motivational interview conducted by the case managers.
The questions and visualizations will be facilitated by an electronic tool for presenting screens with questions, capturing responses, processing and visualizing social network data.
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Residents of a housing first permanent supporting housing program will be randomly assigned to this arm after screening and baseline assessments.
They will meet roughly every two weeks with a case manager and answer questions about their social network, will be shown visual feedback about their networks, and will participate in a motivational interview conducted by the case managers.
The questions and visualizations will be facilitated by an electronic tool for presenting screens with questions, capturing responses, processing and visualizing social network data.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Readiness to change alcohol and other drug use
Időkeret: Baseline and 13-14 weeks (post intervention)
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Measured with 12 item Readiness to Change Questionnaire (RTCQ) and a one item Contemplation Ladder
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Baseline and 13-14 weeks (post intervention)
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Readiness to change risky sexual behavior
Időkeret: Baseline and 13-14 weeks (post intervention)
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11 item Readiness to Change Risky Sexual Behavior (RTCQ-SB) scale a one item Contemplation Ladder
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Baseline and 13-14 weeks (post intervention)
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Self efficacy to change alcohol and other drug use
Időkeret: Baseline and 13-14 weeks (post intervention)
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Measured with two questionnaire items that assess the participant's importance and self-efficacy to stop alcohol and other drug use and 4 items from the Alcohol Abstinence Self-Efficacy Scale (AASE) which measure how confident participants feel in their ability to abstain from alcohol use when depressed, relaxed, craving substances, and offered alcohol.
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Baseline and 13-14 weeks (post intervention)
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Self efficacy to change risky sexual behavior
Időkeret: Baseline and 13-14 weeks (post intervention)
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Measured with 4 item Self-Efficacy to Use Condoms scale
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Baseline and 13-14 weeks (post intervention)
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Self-efficacy to change social networks
Időkeret: Baseline and 13-14 weeks (post intervention)
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Two item ladder scale item measuring importance and self-efficacy to change social networks.
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Baseline and 13-14 weeks (post intervention)
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Perceived Social Network support and approval/disapproval of alcohol, drug use, and risky sex.
Időkeret: Baseline and 13-14 weeks (after intervention)
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Measures of Perceived Social Support and ratings of network members on emotional closeness, drinking, drug use, safe-sex behavior, and approval/disapproval of high-risk behavior of social network members based on the Important People Drug and Alcohol Interview.
Raw network data to provide measures will result from a personal network interview in which participants will name 20 network member and answer questions about each of them and their relationships with each other.
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Baseline and 13-14 weeks (after intervention)
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Drug and Alcohol use
Időkeret: Baseline and 13-14 weeks (after intervention is completed)
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Assessed with a Timeline Followback calendar structured interview that measures alcohol and drug use through recall aided by a calendar.
Participants will be asked quantity and intensity of drinking and drug use to calculate a quantity-frequency index for both drinking and drug use.
Self-reports of non-use will be validated with a Oral Fluid Test.
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Baseline and 13-14 weeks (after intervention is completed)
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HIV risk behavior
Időkeret: baseline and 13-14 weeks (after intervention completion)
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Survey items asking if the participant engaged in unprotected sex and concurrent sexual relationships overall and with particular partners in the past 90 days.
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baseline and 13-14 weeks (after intervention completion)
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Change in social network composition and structure
Időkeret: baseline and 13-14 weeks (after intervention completion)
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Measures of network composition and structure will be constructed from raw network data.
Raw network data result from a personal network interview in which participants will name 20 network member and answer questions about each of them and their relationships with each other.
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baseline and 13-14 weeks (after intervention completion)
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Satisfaction with Intervention
Időkeret: 13-14 weeks (after intervention)
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Administration of the Client Satisfaction Questionnaire (CSQ-8), an 8-item Likert-type measure of client feedback regarding services provided in a treatment program.
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13-14 weeks (after intervention)
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: David P Kennedy, PhD, RAND
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- Kennedy DP, Osilla KC, Hunter SB, Golinelli D, Maksabedian Hernandez E, Tucker JS. Restructuring personal networks with a Motivational Interviewing social network intervention to assist the transition out of homelessness: A randomized control pilot study. PLoS One. 2022 Jan 21;17(1):e0262210. doi: 10.1371/journal.pone.0262210. eCollection 2022.
- Osilla KC, Kennedy DP, Hunter SB, Maksabedian E. Feasibility of a computer-assisted social network motivational interviewing intervention for substance use and HIV risk behaviors for housing first residents. Addict Sci Clin Pract. 2016 Sep 7;11(1):14. doi: 10.1186/s13722-016-0061-x.
- Kennedy DP, Hunter SB, Chan Osilla K, Maksabedian E, Golinelli D, Tucker JS. A computer-assisted motivational social network intervention to reduce alcohol, drug and HIV risk behaviors among Housing First residents. Addict Sci Clin Pract. 2016 Mar 15;11(1):4. doi: 10.1186/s13722-016-0052-y.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2015. június 1.
Elsődleges befejezés (Tényleges)
2016. október 1.
A tanulmány befejezése (Tényleges)
2017. július 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2014. május 14.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2014. május 15.
Első közzététel (Becslés)
2014. május 16.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2017. november 24.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2017. november 21.
Utolsó ellenőrzés
2017. november 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- R34DA034855 (Az Egyesült Államok NIH támogatása/szerződése)
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