- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02140359
Enhancing Housing First Programs With a Social Network Substance Use Intervention
21 novembre 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
50
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
California
-
Los Angeles, California, Stati Uniti, 90021
- Skid Row Housing Trust
-
Santa Monica, California, Stati Uniti, 90407
- RAND Corporation
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: 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.
|
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Readiness to change alcohol and other drug use
Lasso di tempo: Baseline and 13-14 weeks (post intervention)
|
Measured with 12 item Readiness to Change Questionnaire (RTCQ) and a one item Contemplation Ladder
|
Baseline and 13-14 weeks (post intervention)
|
|
Readiness to change risky sexual behavior
Lasso di tempo: Baseline and 13-14 weeks (post intervention)
|
11 item Readiness to Change Risky Sexual Behavior (RTCQ-SB) scale a one item Contemplation Ladder
|
Baseline and 13-14 weeks (post intervention)
|
|
Self efficacy to change alcohol and other drug use
Lasso di tempo: 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)
|
|
Self efficacy to change risky sexual behavior
Lasso di tempo: Baseline and 13-14 weeks (post intervention)
|
Measured with 4 item Self-Efficacy to Use Condoms scale
|
Baseline and 13-14 weeks (post intervention)
|
|
Self-efficacy to change social networks
Lasso di tempo: 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)
|
|
Perceived Social Network support and approval/disapproval of alcohol, drug use, and risky sex.
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Drug and Alcohol use
Lasso di tempo: 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.
|
Baseline and 13-14 weeks (after intervention is completed)
|
|
HIV risk behavior
Lasso di tempo: 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)
|
|
Change in social network composition and structure
Lasso di tempo: baseline and 13-14 weeks (after intervention completion)
|
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)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Satisfaction with Intervention
Lasso di tempo: 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.
|
13-14 weeks (after intervention)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: David P Kennedy, PhD, RAND
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2015
Completamento primario (Effettivo)
1 ottobre 2016
Completamento dello studio (Effettivo)
1 luglio 2017
Date di iscrizione allo studio
Primo inviato
14 maggio 2014
Primo inviato che soddisfa i criteri di controllo qualità
15 maggio 2014
Primo Inserito (Stima)
16 maggio 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 novembre 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 novembre 2017
Ultimo verificato
1 novembre 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R34DA034855 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Bere alcolici
-
Mayo ClinicJames and Esther King Biomedical Research ProgramCompletatoIntervento comportamentale integrato per il fumo di sigaretta e il binge drinking nei giovani adultiper la cessazione del fumo di sigaretta e del binge drinkingStati Uniti
-
HBSAReclutamentoBinge drinking, consumo di alcol da parte di minorenni, guida in stato di ebbrezza, danni correlati all'alcolStati Uniti
Prove cliniche su Motivational Network Interview
-
Ruhr University of BochumCompletatoMalattia psicologicaGermania
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletatoSovrappeso e obesitàStati Uniti
-
University of ZurichCompletatoDisturbo post traumatico da stress (PTSD) | Disturbo da stress post-traumatico complesso (CPTSD)Svizzera
-
Lisa DixonRitiratoSchizofrenia | Primo episodio di psicosiStati Uniti
-
Nopparatrajathanee HospitalCompletatoNascita prematuraTailandia
-
Medical College of WisconsinNational Institute of Mental Health (NIMH)Completato
-
Centre Hospitalier Universitaire, AmiensCompletatoIctus | Disturbi comportamentali | Disturbi cognitiviFrancia
-
Brigham and Women's HospitalNational Institute on Aging (NIA)TerminatoIpertensione | Ictus, ischemico acutoStati Uniti
-
Medical College of WisconsinEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletatoSindrome da immunodeficienza acquisita | HIVBulgaria
-
Icahn School of Medicine at Mount SinaiNorthwestern University; The Cleveland Clinic; University of California, Davis; R...CompletatoMalattia infiammatoria intestinale (IBD)Stati Uniti