- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02140359
Enhancing Housing First Programs With a Social Network Substance Use Intervention
21. listopadu 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
50
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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California
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Los Angeles, California, Spojené státy, 90021
- Skid Row Housing Trust
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Santa Monica, California, Spojené státy, 90407
- RAND Corporation
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: 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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|
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Experimentální: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Readiness to change alcohol and other drug use
Časové okno: Baseline and 13-14 weeks (post intervention)
|
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)
|
|
Readiness to change risky sexual behavior
Časové okno: Baseline and 13-14 weeks (post intervention)
|
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)
|
|
Self efficacy to change alcohol and other drug use
Časové okno: Baseline and 13-14 weeks (post intervention)
|
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.
|
Baseline and 13-14 weeks (post intervention)
|
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Self efficacy to change risky sexual behavior
Časové okno: Baseline and 13-14 weeks (post intervention)
|
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
Časové okno: Baseline and 13-14 weeks (post intervention)
|
Two item ladder scale item measuring importance and self-efficacy to change social networks.
|
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.
Časové okno: Baseline and 13-14 weeks (after intervention)
|
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.
|
Baseline and 13-14 weeks (after intervention)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Drug and Alcohol use
Časové okno: Baseline and 13-14 weeks (after intervention is completed)
|
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
Časové okno: baseline and 13-14 weeks (after intervention completion)
|
Survey items asking if the participant engaged in unprotected sex and concurrent sexual relationships overall and with particular partners in the past 90 days.
|
baseline and 13-14 weeks (after intervention completion)
|
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Change in social network composition and structure
Časové okno: 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.
|
baseline and 13-14 weeks (after intervention completion)
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Satisfaction with Intervention
Časové okno: 13-14 weeks (after intervention)
|
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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: David P Kennedy, PhD, RAND
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. června 2015
Primární dokončení (Aktuální)
1. října 2016
Dokončení studie (Aktuální)
1. července 2017
Termíny zápisu do studia
První předloženo
14. května 2014
První předloženo, které splnilo kritéria kontroly kvality
15. května 2014
První zveřejněno (Odhad)
16. května 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. listopadu 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
21. listopadu 2017
Naposledy ověřeno
1. listopadu 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R34DA034855 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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