- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01948440
ASI-MV Solutions: A Tailored Program for Substance Abusers in Early Recovery
20. september 2013 oppdatert av: Emil Chiauzzi, Inflexxion, Inc.
Making referrals to medical and psychosocial services for substance abuse clients has proven difficult due to lack of access to services, inadequate counselor knowledge, and lack of motivation and skills among clients.
Inflexxion is proposing the development of ASI-MV Solutions, which will educate clients about employment, legal, psychiatric, relapse prevention, medical, and family issues, as well as include resources and strategies for counselors.
By linking learning modules to client results on the ASI-MV, an online interactive version of the ASI administered in treatment settings, we will be able to offer clients important tools to address key recovery issues and encourage counselors to make appropriate referrals to medical and psychosocial services.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Substance abuse research indicates that: (1) addressing medical and psychosocial problems associated with substance abuse and dependence leads to better outcomes; (2) treatments are now shorter due in part to rising healthcare costs, and it is difficult to address these issues effectively during treatment, making medical and psychosocial ("wraparound") services following treatment essential; (3) counselors may lack the knowledge to effectively integrate these services; and (4) referrals to these services have been underutilized and clients may lack the motivation, knowledge, or skills to follow up with the referrals when they are made.
To address these deficits, we are proposing the development of ASI-MV Solutions, which will provide tailored motivational feedback and skill-building lessons to clients to address specific psychosocial and medical problem areas.
We expect that ASI-MV Solutions will have seven modules (Alcohol, Drugs, Medical, Psychiatric, Legal, Employment, and Family) corresponding to domains of the ASI-MV, a Web-enabled interactive version of the ASI administered in treatment settings.
Substance abusers who have high severity scores on ASI-MV subscales will be directed to corresponding interactive lessons and local resources on ASI-MV Solutions.
To demonstrate the feasibility of the program concept, the Phase I study focused on the Employment domain.
All feasibility criteria were met and findings indicated: (1) Proposed content was based on highly positive findings from concept mapping, as well as usability and acceptance testing with clients and experts.
Ratings of potential effectiveness and appeal were high.
(2) Usability testing indicated that the program was usable by the target audience, the skills and outcomes were relevant to the target audience, and the program was regarded as potentially very helpful to the treatment process.
We surpassed feasibility benchmarks for both clients and experts.
(3) Our technical/design team produced a demonstration program that was perceived by key stakeholders as highly usable and engaging multimedia program, as well as determining the necessary technologies to produce the complete program in Phase II.
In Phase II we will develop ASI-MV Solutions content, complete the ASI-MV Solutions program, field test the program, and conduct satisfaction and acceptance testing of the program with clients and counselors.
Studietype
Intervensjonell
Registrering (Faktiske)
39
Fase
- Fase 2
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Client Inclusion Criteria. We will recruit participants in the same proportions as in usability testing - 40% female, 40% minorities. The inclusion criteria for clients are the same as those for usability testing, except that we will require the participant to provide: (1) the names of at least three contacts who can help locate the client during the study, and (2) multiple means of contacting them (telephone, mail, and/or email). As with usability participants, we will seek clients who are in the early stages of treatment (30 days or less, including new intakes).
Exclusion Criteria:
- None
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: ASI-MV Solutions
The Experimental group will complete the ASI-MV and use the ASI-MV Solutions program for eight 30-minute sessions, followed by monthly booster sessions.
The Experimental group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention.
|
The Experimental group will complete the ASI-MV and use the ASI-MV Solutions program for eight 30-minute sessions, followed by monthly booster sessions.
The Experimental group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention.
|
|
Ingen inngripen: Treatment as Usual
The Control group participants will complete the ASI-MV and receive their normal course of treatment.
The Control group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
improved outcomes, as measured by substance use, psychosocial, and psychological functioning
Tidsramme: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
Addiction Severity Index - Multimedia Version (ASI-MV)
|
baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
|
greater problem-services matching, as measured by the number and fit of referred/received services
Tidsramme: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
Treatment Services Checklist (Client Version) and Treatment Services Checklist (Counselor Version).
|
baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
|
greater treatment motivation
Tidsramme: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES, Version 8D; Miller & Tonigan, 1996)
|
baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
|
greater self-efficacy in managing psychosocial issues
Tidsramme: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
Drug Avoidance Self-Efficacy Scale
|
baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
treatment compliance
Tidsramme: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
Treatment Compliance: We will ask counselors to record scheduled and planned sessions within the treatment facility as a way of assessing treatment compliance.
We will also ask counselors to record client reasons for leaving treatment prematurely (Against Medical Advice, moving, hospitalization, etc.).
|
baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
|
treatment alliance with counselors
Tidsramme: baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
Working Alliance Inventory-Short Form (Clients) and Working Alliance Inventory-Short Form (Counselors)
|
baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Emil Chiauzzi, PhD, Inflexxion, Inc.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2010
Primær fullføring (Faktiske)
1. juli 2013
Studiet fullført (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først innsendt
27. juli 2010
Først innsendt som oppfylte QC-kriteriene
20. september 2013
Først lagt ut (Anslag)
23. september 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. september 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. september 2013
Sist bekreftet
1. september 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2R44DA026232-02 (U.S. NIH-stipend/kontrakt)
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