- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01948440
ASI-MV Solutions: A Tailored Program for Substance Abusers in Early Recovery
20 septembre 2013 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
39
Phase
- Phase 2
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Aucune intervention: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
improved outcomes, as measured by substance use, psychosocial, and psychological functioning
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
treatment compliance
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Emil Chiauzzi, PhD, Inflexxion, Inc.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2010
Achèvement primaire (Réel)
1 juillet 2013
Achèvement de l'étude (Réel)
1 juillet 2013
Dates d'inscription aux études
Première soumission
27 juillet 2010
Première soumission répondant aux critères de contrôle qualité
20 septembre 2013
Première publication (Estimation)
23 septembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
23 septembre 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 septembre 2013
Dernière vérification
1 septembre 2013
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2R44DA026232-02 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur ASI-MV Solutions
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University of ManitobaSt. Boniface Hospital; Arterial Stiffness IncorporatedRésiliéMaladie de l'artère coronaire | En bonne santé | Obésité | Maladie artérielle périphérique | Diabète de type 2Canada
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Royal Marsden NHS Foundation TrustImperial College London; Institute of Cancer Research, United Kingdom; RM Partners...RecrutementFumeur | Alcoolisme | Maladies urologiques | Hypertension | Diabète | Cancer de la prostate | Cancer de la vessie | Cancer du rein | Cancer urologique | Problème de santé mentale | Cancer du testiculeRoyaume-Uni
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Daping Hospital and the Research Institute of Surgery...Inconnue
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Rutgers, The State University of New JerseyRecrutementLa dépression | Troubles du spectre autistique | Autisme | Trouble du spectre autistique avec troubles du langage fonctionnelÉtats-Unis
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Bandim Health ProjectAarhus University Hospital; Rigshospitalet, DenmarkComplétéMortalité | Hospitalisation | Événements indésirablesGuinée-Bissau
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Themis Bioscience GmbHWalter Reed Army Institute of Research (WRAIR)Complété
-
Themis Bioscience GmbHComplétéInfection par le virus ChikungunyaRoyaume-Uni
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Fuda Cancer Hospital, GuangzhouComplétéTumeurs pulmonairesChine
-
IRCCS Centro Neurolesi "Bonino-Pulejo"ComplétéAccident vasculaire cérébral
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Themis Bioscience GmbHWalter Reed Army Institute of Research (WRAIR)ComplétéInfection par le virus ChikungunyaPorto Rico