- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02083523
Project CHOICE: Efficacy Testing of CHOICE and CHOICE+Normative Feedback Interventions (CHOICE)
10. marts 2014 opdateret af: Douglas Smith, University of Illinois at Urbana-Champaign
PROJECT CHOICE: Efficacy Testing of Motivational Interviewing (MI) for Adolescents Referred for Substance Use Concerns
This study will use a pilot test format to examine the efficacy of a brief Motivational Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will use a pilot test format to examine the efficacy of a brief Motivational Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL.
The study will have two arms: one group will receive the standard CHOICE Motivational Interview (MI) while the second group will receive the CHOICE Motivational Interview with a Normative Feedback component, called CHOICE+ (CHOICE Plus).
The hypothesis is that there will be no difference in outcomes between those that receive the standard CHOICE and those that receive the CHOICE+ MI.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
48
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
13 år til 19 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Youth 13-19 years of age (and their parents or legal guardians if their youth has been referred for an assessment with the Prairie Center counseling staff.)
- referred for an assessment to see if they need substance use disorder treatment
- have used substances on 13 or more days out of the past 90 days or scored higher than 2 on the CRAFT assessment. -
Exclusion Criteria:
- Low cognitive functioning
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Motivational Interview
The Motivational Interview, or MI, (15-30 minutes) was provided after initial substance use disorder assessments but prior to treatment admission.
I twas facilitated by a computer generated report and included: an orientation to the session, discussion of the participants' strengths, an agenda setting procedure, a review of concerns, and a session summary.
Therapists conveyed empathy, used reflective listening, tried to elicit and reinforce change talk elements, and elicited action steps from the participants.
|
The Motivational Interview (MI) addresses ambivalence about change.
It's effects are mediated by how well counselors evoke change talk, or in-session client utterances about the: need for; commitment to; ability to; or steps needed, to change.
Andre navne:
|
Aktiv komparator: MI with Normative Feedback
The Motivational Interview with Normative Feedback, or MI + NF, condition/intervention included all procedures described for the MI condition.
Additionally, in the MI + NF condition/intervention, the participants' days of marijuana and alcohol use were compared to two sets of norms ( age specific or level of care specific) available for treatment attending youth.
Therapists used whichever norm provided a greater contrast with participants' use.
|
NOrmative Feedback (NF) contrasts and individual's substance use to available norms for one's reference group (i.e., descriptive norms.)
Essentially, NF highlights how an individual's behavior is non-normative, which in turn, is thought to lead to reduced substance use.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
% Readiness to Change
Tidsramme: Day One
|
% Readiness to Change was measured immediately following receipt of the intervention session.
|
Day One
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Days of Substance Use Treatment
Tidsramme: 3 months post intake
|
3 months post intake
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Substance Use Frequency
Tidsramme: 3 months post intake
|
3 months post intake
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Douglas Smith, PhD, University of Illinois Urbana Champaign
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2013
Primær færdiggørelse (Faktiske)
1. august 2013
Studieafslutning (Faktiske)
1. august 2013
Datoer for studieregistrering
Først indsendt
9. januar 2014
Først indsendt, der opfyldte QC-kriterier
10. marts 2014
Først opslået (Skøn)
11. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Smith13356
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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