- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05657119
Familiesikkerhedsnet - Mål 3: Randomiseret kontrolforsøg (FSN)
Familiesikkerhedsnet: Udvikling af en opstrøms selvmordsforebyggende tilgang til at tilskynde til sikker opbevaring af skydevåben i landdistrikter og fjerntliggende områder
Målet med dette kliniske forsøg er at teste Family Safety Net-interventionen (FSN) i en primært indfødt Alaska-befolkning i NW Alaska. Hovedspørgsmålet, som det sigter mod at besvare er:
• Er Family Safety Net-interventionen (FSN) mulig og acceptabel i en primært indfødt Alaska-befolkning i det nordvestlige Alaska.
Interventionsdeltagere vil gennemføre:
- Screeningsundersøgelse - Hver husstand modtager en kupon, som en voksen kan tage med tilbage for at tage screeningsundersøgelsen og deltage i lodtrækningen.
- Baseline-undersøgelser - Vi vil gennemføre undersøgelser med personer med mindst én pistol i deres hjem, og som svarer "ja" til et af vores syv mentale sundhedsspørgsmål om en anden i deres hjem:
- Kort motiverende interviewsession (MI) - Deltagerne vil modtage en 20-minutters session udført af uddannet forskningspersonale fra University of Michigan for at tilskynde til sikker opbevaring af skydevåben i deltagernes hjem.
- Tilbyder materialer med hjem - Efter den korte MI-session vil der blive tilbudt skydevåbensikkerhedsgenstande, herunder aftrækkerlåse, kabellåse og ammunitionsbokse. Derudover vil elementer, der fremmer mental sundhed, også være tilgængelige, herunder Careline-magneter, undervisningsmateriale, flyers til kommende forældrekurser osv.
- 4-ugers tekstbeskeder - Deltagerne vil modtage SMS-påmindelser, og opmuntring vil blive skræddersyet af undersøgelsessvar og leveret mellem 2x og 4X ugentligt afhængigt af baseline-undersøgelsens svar.
- 1-måneders opfølgning Qualtrics-undersøgelse - Opfølgningsundersøgelsen består af baseline-undersøgelsen + 9 tilfredshedsspørgsmål om MI-sessionerne, hjembragt materiale, modtagede SMS-beskeder og foretaget handlinger
Forskere vil sammenligne folk fra den samme befolkning for at se, om husholdningspraksis for skydevåben ændres på grund af MI-indgrebet og adgang til skydevåbensikkerhedsanordninger.
- Screeningsundersøgelse - Hver husstand modtager en kupon, som en voksen kan tage med tilbage for at tage screeningsundersøgelsen og deltage i lodtrækningen.
- Baseline-undersøgelser - Vi vil gennemføre undersøgelser med personer med mindst én pistol i deres hjem:
- Modtag information - Sammenligningsarmen modtager information om sikker opbevaring af skydevåben og husholdningssikkerhed.
- Tilbyder materialer til at tage med hjem - Sammenligningsarmen modtager våbensikkerhedsinformationen og vil blive tilbudt at tage en kuliltedetektor med hjem og information om mental sundhed.
- 1-måneders opfølgning Qualtrics-undersøgelse - Opfølgningsundersøgelsen består af baseline-undersøgelsen + 9 tilfredshedsspørgsmål om MI-sessionerne, hjembragt materiale, modtagede SMS-beskeder og foretaget handlinger
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Målet med dette kliniske forsøg er at teste Family Safety Net-interventionen (FSN) i en primært indfødt Alaska-befolkning i NW Alaska. Hovedspørgsmålet, som det sigter mod at besvare er:
- Er Family Safety Net-interventionen (FSN) mulig og acceptabel i en primært indfødt Alaska-befolkning i NW Alaska.
- En voksen pr. husstand i et lokalsamfund vil udfylde et meget kort spørgeskema for at kontrollere deres berettigelse til at deltage i undersøgelsen. Ved at komme til lokaliteten i lokalsamfundet og udfylde en 5-minutters screeningsundersøgelse, vil hver deltager deltage i en lodtrækning om at modtage en tønde på 500 $ fyringsolie. Enhver, der kommer med en rekrutteringsvoucher, vil tage en 5-minutters Qualtrics-undersøgelse på iPad. Screeningsundersøgelsen søger at identificere dem, der opfylder vores berettigelseskriterier.
- Screeningsundersøgelsen vil linke til en samtykkeerklæring med en unik identifikator, hvis personen er kvalificeret til at deltage i undersøgelsen. Forskningspersonale vil bekræfte berettigelseskriterier og gennemgå samtykkeformularen på iPad og besvare deltagerens spørgsmål. Hvis de accepterer at deltage, vil de markere deres samtykke og blive tilfældigt tildelt sammenlignings- eller interventionsgruppen.
- Når folk accepterer at deltage i en af grupperne, vil de blive bedt om at udfylde en 10-15-minutters basisundersøgelse uafhængigt på iPad.
- Efter at deltagerne har gennemført baselineundersøgelsen, vil interventionisten facilitere det 10-15 minutter lange baseline strukturerede interview.
For interventionsgruppedeltagere vil de deltage i en kort 20-30 minutters motiverende interviewsession (MI), der inkluderer:
- introduktion til sessionen og fastsættelse af dagsordenen;
- at diskutere personens mål og styrker i forbindelse med at holde sine kære sikre gennem sikker opbevaring af skydevåben (f. at gøre sit hjem mere sikkert for at beskytte den unge eller anden familie, der bor der) og støtte velvære (dvs. fremme af mental sundhed);
- at tilbyde normativ feedback om sikker skydevåbenopbevaringspraksis i samfundet;
- tale om fordelene ved sikrere våbenopbevaringspraksis (f.eks. forbedring af unges sikkerhed eller undgåelse af unge skader);
- handlingsplanlægning for at øge selveffektiviteten for at overvinde barrierer og bevæge sig hen imod at reducere adgangen til skydevåben ved at låse og losse alle husholdningsvåben;
- tilbyde ideer om vigtigheden af at støtte andre på 'ikke-krævende' måder;
- Handlingsplanlægning for at brainstorme måder at støtte andre i husstanden på på ikke-krævende måder;
- udvælgelse af sikre opbevaringsenheder til at tage med hjem som "signaler til handling" (f.eks. magneter, aftrækkerlåse, kabellåse, medicinæsker osv.); og
- udvælgelse af wellness-ressourcer (f.eks. magneter til mentale sundhedsressourcer, You Matter-kort, slik at dele, lokale ressourceoplysninger osv.);
opsummering af sessionens nøgleindhold for at styrke fordele, mål og værdier og støtte selveffektivitet for at lette sikker skydevåbenopbevaring og velværestøtte i hjemmet. Afhængigt af deltagerens interesser og mål vil denne MI-session fokusere på sikker opbevaring af skydevåben, støtte andre i deres husstands mentale velvære eller begge dele.
- Modtag 4-ugers tekstbeskeder skræddersyet til deres undersøgelsessvar (1x til 4x ugentligt afhængigt af baseline-undersøgelsen og baseline-strukturerede interviewsvar). De kan til enhver tid fravælge det.
- En måned efter den indledende session, for både sammenlignings- og interventionsgrupper, vil et link blive sendt til deltagerne via tekst/e-mail for at udfylde en 10-15-minutters (afhængigt af skiplogik) opfølgningsundersøgelse. Opfølgningsundersøgelsen består af emner relateret til skydevåbenopbevaring og faciliterende faktorer, der antages at bidrage til denne adfærd. Undersøgelsen vil omfatte emnefokuserede forandringsmekanismer, herunder selveffektivitet, og om den nuværende våbenopbevaring i husstanden (antal og type skydevåben; låst/ulåst, lastet/aflæsset og placering af ammunition for hver) og foranstaltninger, der er truffet for at støtte mentalt velvære for andre i deres hjem. Derudover vil de, der gjorde FSN, også besvare spørgsmål om deres tilfredshed med FSN (acceptabilitet, kulturel lydhørhed). For både sammenlignings- og interventionsgrupper vil opfølgningen fange et "øjebliksbillede" af nuværende husholdningspraksis for skydevåbenopbevaring den dag. Derudover vil deltagerne have mulighed for at tage opfølgningsundersøgelsen personligt på en iPad med forskerholdet og vil på forhånd blive informeret om dag, tidspunkt og sted, hvor forskerholdet vil være tilgængeligt.
Forskere vil sammenligne folk fra den samme befolkning for at se, om husholdningspraksis for skydevåben ændres på grund af MI-indgrebet og adgang til skydevåbensikkerhedsanordninger.
Sammenligningsgruppe:
- Når folk accepterer at deltage og tilfældigt tildeles sammenligningsgruppen, vil de blive bedt om at gennemføre en 10-15-minutters baseline-undersøgelse uafhængigt på iPad.
- Efter at deltagerne har gennemført baselineundersøgelsen, vil interventionisten facilitere det 10-15 minutter lange baseline strukturerede interview.
- Deltag i en sikkerhedsdiskussion i hjemmet, og tag en kuliltedetektor, et kulilteinformationsark, en pjece til opbevaring af våben og en magnet for mental sundhed med hjem.
- En måned efter den indledende session vil der blive sendt et link til deltagerne via tekst/e-mail for at udfylde en 10-15 minutters (afhængigt af spring logik) opfølgningsundersøgelse. Opfølgningsundersøgelsen består af emner relateret til skydevåbenopbevaring og faciliterende faktorer, der antages at bidrage til denne adfærd. Undersøgelsen vil omfatte emnefokuserede forandringsmekanismer, herunder selveffektivitet, og om den nuværende våbenopbevaring i husstanden (antal og type skydevåben; låst/ulåst, lastet/aflæsset og placering af ammunition for hver) og foranstaltninger, der er truffet for at støtte mentalt velvære for andre i deres hjem. Derudover vil de, der gjorde FSN, også besvare spørgsmål om deres tilfredshed med FSN (acceptabilitet, kulturel lydhørhed). For både sammenlignings- og interventionsgrupper vil opfølgningen fange et "øjebliksbillede" af nuværende husholdningspraksis for skydevåbenopbevaring den dag. Derudover vil deltagerne have mulighed for at tage opfølgningsundersøgelsen personligt på en iPad med forskerholdet og vil på forhånd blive informeret om dag, tidspunkt og sted, hvor forskerholdet vil være tilgængeligt.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Alaska
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Kotzebue, Alaska, Forenede Stater, 99752
- Maniilaq Association
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Voksne (over 18), som:
- Har boet i regionen i 5+ år,
- Læs og forstå engelsk,
- Bor i en husstand med mindst én pistol,
- Har en telefon, der kan modtage tekster,
- Bor i husstand med mindst én anden person
Ekskluderingskriterier:
- En person, der udtrykker selvmordstanker eller planer
- Under 18 år
- Bor alene i husstand
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: FSN Lethal Means Scripted Intervention
Participants were randomized to one of two lethal-means reduction-focused FSN programs if they answer "yes" to any of the screening questions.
The scripted FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home.
Using a handout depicting a typical home, participants review where firearms, ammunition, and medications are stored, reinforcing that "10 minutes can save a life" and encouraging the display of mental health resources.
Participants receive safe firearm storage materials and #988 crisis line magnets and stickers.
They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices).
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Scripted lethal betyder reduktion, skydevåbenopbevaring, skræddersyede tekstbeskeder
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Aktiv komparator: General Firearm Safety Comparison
Participants were randomized to one of two general safety conditions if they answered "no" to all of the following screening questions:
|
forsyninger til opbevaring af skydevåben * Få tilbud om at tage sikkert våbenopbevaringsmateriale med hjem, inklusive aftrækkerlåse, kabellåse og ammunitionsbokse |
|
Eksperimentel: Experimental: FSN Lethal Means MI Counseling
Participants will be screened into one of two lethal-means reduction-focused FSN programs if they answer "yes" to one or more of the screening questions.
The MI FSN intervention addresses the connection between a loved one's mental health and the participant's home firearm and medication storage, focusing on what the participant could do to reduce the risk of suicide for a particular loved one in their home.
The MI session asked broad open-ended questions about what that person might do to increase environmental safety in their home.
At the end of the session, participants were offered firearm safe storage resources to take home, as well as magnets and stickers with #988, the national crisis line.
They also receive 1-4 weeks of tailored automated text messages based on baseline responses (e.g., presence of children and storage practices).
|
Motiverende samtale dødbringende betyder reduktion, skydevåbenopbevaring, skræddersyede tekstbeskeder
|
|
Aktiv komparator: General Firearm Safety Intervention
Participants were randomized to one of two general safety conditions if they answered "no" to all of the following screening questions:
|
Generel information om våbensikkerhed, skydevåbenopbevaring, skræddersyede tekstbeskeder
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of the Intervention
Tidsramme: Baseline
|
Feasibility was measured by examining the number of people who met eligibility criteria and chose to participate in the study.
This basic process measure allowed us to assess the scope and scalability of the FSN intervention.
|
Baseline
|
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Participant Agreement With the Statement: "I am Glad I Participated in the Family Safety Net"
Tidsramme: Assessed at 6 week follow up
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Participants were asked how much they agree with the statement "I am glad I participated in the Family Safety Net" using a 10-point Likert scale (1-10 agreement scale).
Items with an average 5.5 or more were considered acceptable.
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Assessed at 6 week follow up
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Participant Agreement With the Statement: "I Would Recommend the Family Safety Net"
Tidsramme: Assessed at 6 week follow up
|
Participants were asked how much they agree with the statement "I would recommend the Family Safety Net" using a 10-point Likert scale (1-10 agreement scale).
Items with an average 5.5 or more were considered acceptable.
|
Assessed at 6 week follow up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Household Firearm Storage
Tidsramme: Assessed at baseline and 6-week follow up; 6 week follow up reported
|
We developed a firearm inventory to assess safety practices for up to five firearms in the home.
For each reported firearm, participants indicated whether: (1) the firearm was locked with a cable or trigger lock or stored in a locked gun safe or cabinet; (2) the firearm was unloaded; (3) ammunition was stored separately from the firearm; and (4) the ammunition was locked in an ammunition box.
Each safe storage practice endorsed was assigned one point, yielding a score of 0-4 per firearm.
Scores were then averaged across all reported firearms to create a composite safe storage score.
If a participant reported that a firearm named on the baseline was no longer in the home at follow-up, they were asked if they had moved the firearm out of the house for safety reasons.
If they removed a firearm, they were not asked the safe storage questions for that firearm, and it was not calculated in the total composite score.
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Assessed at baseline and 6-week follow up; 6 week follow up reported
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Lisa M Wexler, PhD, MSW, University of Michigan
Publikationer og nyttige links
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