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"Effectiveness of a Brief Intervention for Substances Consumption Linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): A Randomized Control Trial in Chilean Primary Care."

Primary Purpose

Alcohol-Related Disorders, Substance-Related Disorders, Substance Abuse

Status
Completed
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
ASSIST-linked brief intervention for hazardous and harmful substance use.
Observation
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol-Related Disorders focused on measuring Alcohol, Abuse, Drugs, Brief intervention, ASSIST

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and women older than 18 years and 50 years
  • Achieving a moderate risk score in the ASSIST screening questionnaire.
  • Without any similar intervention in the last 3 months. (ie. AUDIT test).

Exclusion Criteria:

  • Pregnant women.
  • Users with cognitive disabilities.
  • Users with language and communication disabilities.

Sites / Locations

  • CESFAM Dr. Sergio Aguilar
  • CESFAM San Juan
  • CESFAM Santa Cecilia
  • CESFAM Tierras Blancas
  • SAPU Dr. Sergio Aguilar
  • SAPU Tierras Blancas
  • 5ta. Comisaría Conchalí
  • CS Alberto Bachelet
  • CS José Symon Ojeda
  • CS Juanita Aguirre
  • CS Lucas Sierra
  • SAPU Lucas Sierra
  • 43va. Comisaría Peñalolén
  • CESFAM Lo Hermida
  • CESFAM Padre Gerardo Whelan
  • CS Carol Urzúa Ibañez
  • CS La Faena
  • SAPU Lo Hermida
  • 26va. Comisaría Pudahuel
  • CESFAM Gustavo Molina
  • CESFAM RAúl Silva Henríquez
  • CESFAM Violeta Parra
  • Consultorio Estrella
  • SAPU La Estrella
  • 14va. Comisaría San Bernardo
  • APS Carol Urzúa
  • APS Confraternidad
  • APS El Manzano
  • APS Raúl Cuevas
  • SAPU Raúl Brañes

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

Intervention group

Arm Description

Outcomes

Primary Outcome Measures

Post-intervention ASSIST screening score.
3 months after being recruited, users with moderate risk in the ASSIST questionnaire who received either a brief intervention or observation will be re-evaluated with the same ASSIST instrument. In both the intervened and the control group, changes in the post-intervention ASSIST score will be measured.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2012
Last Updated
October 8, 2013
Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01573416
Brief Title
"Effectiveness of a Brief Intervention for Substances Consumption Linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): A Randomized Control Trial in Chilean Primary Care."
Official Title
"Effectiveness of a Brief Intervention for Substances Consumption Linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): A Randomized Control Trial in Chilean Primary Care."
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Alcohol and drugs consumption are among the highest risk factor for health in Chile and abroad. In Chile, harmful use of alcohol continues to be a major contributor to the burden of disease while lost years of healthy life are higher than many other risk factors such as hypertension, overweight and obesity, and hyperglycemia. It is important to say that the impact of alcohol consumption is greater in younger age groups where fatal injuries occur relatively early in life, as well. In Chile, the consumption pattern in 2008 showed that 49.8 % consumed at least once in the last month for alcohol, 3.5 % for marihuana and 1.3 % for cocaine. This prevalence was even greater in young adults and adolescents and is associated with other mental health issues and poorer life quality. Those who have consumed marihuana during the last year, 25% report dependence symptoms. For cocaine derives, dependency rises up to 50% among the consumers. This data reinforce the need to design and implement strategies for reducing alcohol and drugs consumption in our population. Also, it is well known that a high number of those who suffers from any addiction problem do not get attention in a specialized center. The are many barriers to do so, such as lack of motivation, lack of resources, social problems, access to care problems, and so on. Chile has a shortage of preventive interventions for those at risk to develop an addiction at an early stage of substance use because front line health services (Primary health care and emergency care) and other social services (police stations, local justice courts) do not have a screening system and a model of brief intervention. The Pontificia Universidad Catolica de Chile, through its Addiction Studies Center (CEDA UC) and its Department of Family Medicine, is working in conjunction with SENDA (Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol ) to design, implement and evaluate a communal system for early detection, brief intervention and referral to treatment (SBIRT), in people older than 18 years, with substance consumption in five municipalities in the country. The aid of this study is to demonstrate that a model of brief intervention is more effective than the approach currently used in patients with substance use at moderate risk (i.e.follow-up). It is a multicentric randomized controlled trial, single blind, with a group to receive brief intervention and a control group that is kept in control and waiting list being re-evaluated three months later. The target population is composed by users whose ASSIST screening scores place them in the moderate risk group, for which there has not been defined a structured intervention yet by our health system. The information will be obtained from the scores obtained after the application of the ASSIST-WHO questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders, Substance-Related Disorders, Substance Abuse
Keywords
Alcohol, Abuse, Drugs, Brief intervention, ASSIST

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Title
Intervention group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
ASSIST-linked brief intervention for hazardous and harmful substance use.
Intervention Description
ASSIST-linked brief intervention will be applied to users achieving moderate risk scores in the ASSIST questionnaire. If after randomization are selected to enter the intervention group, they will receive a ten minute counseling carried immediately after the screening instrument. This intervention group will be re-evaluated after 3 months with the same ASSIST screening instrument.
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Subjects who obtain a moderate risk score in the ASSIST screening questionnaire and after randomization are selected for the control group, will receive a brochure with substance-abuse information without any further conversation about the subject with the caregiver. This observation group will be re-evaluated after 3 months with the same ASSIST screening instrument.
Primary Outcome Measure Information:
Title
Post-intervention ASSIST screening score.
Description
3 months after being recruited, users with moderate risk in the ASSIST questionnaire who received either a brief intervention or observation will be re-evaluated with the same ASSIST instrument. In both the intervened and the control group, changes in the post-intervention ASSIST score will be measured.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women older than 18 years and 50 years Achieving a moderate risk score in the ASSIST screening questionnaire. Without any similar intervention in the last 3 months. (ie. AUDIT test). Exclusion Criteria: Pregnant women. Users with cognitive disabilities. Users with language and communication disabilities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Poblete, MD, MPH
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Study Director
Facility Information:
Facility Name
CESFAM Dr. Sergio Aguilar
City
Coquimbo
State/Province
IV
Country
Chile
Facility Name
CESFAM San Juan
City
Coquimbo
State/Province
IV
Country
Chile
Facility Name
CESFAM Santa Cecilia
City
Coquimbo
State/Province
IV
Country
Chile
Facility Name
CESFAM Tierras Blancas
City
Coquimbo
State/Province
IV
Country
Chile
Facility Name
SAPU Dr. Sergio Aguilar
City
Coquimbo
State/Province
IV
Country
Chile
Facility Name
SAPU Tierras Blancas
City
Coquimbo
State/Province
IV
Country
Chile
Facility Name
5ta. Comisaría Conchalí
City
Conchalí
State/Province
RM
Country
Chile
Facility Name
CS Alberto Bachelet
City
Conchalí
State/Province
RM
Country
Chile
Facility Name
CS José Symon Ojeda
City
Conchalí
State/Province
RM
Country
Chile
Facility Name
CS Juanita Aguirre
City
Conchalí
State/Province
RM
Country
Chile
Facility Name
CS Lucas Sierra
City
Conchalí
State/Province
RM
Country
Chile
Facility Name
SAPU Lucas Sierra
City
Conchalí
State/Province
RM
Country
Chile
Facility Name
43va. Comisaría Peñalolén
City
Peñalolén
State/Province
RM
Country
Chile
Facility Name
CESFAM Lo Hermida
City
Peñalolén
State/Province
RM
Country
Chile
Facility Name
CESFAM Padre Gerardo Whelan
City
Peñalolén
State/Province
RM
Country
Chile
Facility Name
CS Carol Urzúa Ibañez
City
Peñalolén
State/Province
RM
Country
Chile
Facility Name
CS La Faena
City
Peñalolén
State/Province
RM
Country
Chile
Facility Name
SAPU Lo Hermida
City
Peñalolén
State/Province
RM
Country
Chile
Facility Name
26va. Comisaría Pudahuel
City
Pudahuel
State/Province
RM
Country
Chile
Facility Name
CESFAM Gustavo Molina
City
Pudahuel
State/Province
RM
Country
Chile
Facility Name
CESFAM RAúl Silva Henríquez
City
Pudahuel
State/Province
RM
Country
Chile
Facility Name
CESFAM Violeta Parra
City
Pudahuel
State/Province
RM
Country
Chile
Facility Name
Consultorio Estrella
City
Pudahuel
State/Province
RM
Country
Chile
Facility Name
SAPU La Estrella
City
Pudahuel
State/Province
RM
Country
Chile
Facility Name
14va. Comisaría San Bernardo
City
San Bernardo
State/Province
RM
Country
Chile
Facility Name
APS Carol Urzúa
City
San Bernardo
State/Province
RM
Country
Chile
Facility Name
APS Confraternidad
City
San Bernardo
State/Province
RM
Country
Chile
Facility Name
APS El Manzano
City
San Bernardo
State/Province
RM
Country
Chile
Facility Name
APS Raúl Cuevas
City
San Bernardo
State/Province
RM
Country
Chile
Facility Name
SAPU Raúl Brañes
City
San Bernardo
State/Province
RM
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
22126102
Citation
Humeniuk R, Ali R, Babor T, Souza-Formigoni ML, de Lacerda RB, Ling W, McRee B, Newcombe D, Pal H, Poznyak V, Simon S, Vendetti J. A randomized controlled trial of a brief intervention for illicit drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in clients recruited from primary health-care settings in four countries. Addiction. 2012 May;107(5):957-66. doi: 10.1111/j.1360-0443.2011.03740.x. Epub 2012 Feb 28.
Results Reference
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PubMed Identifier
12958114
Citation
Beich A, Thorsen T, Rollnick S. Screening in brief intervention trials targeting excessive drinkers in general practice: systematic review and meta-analysis. BMJ. 2003 Sep 6;327(7414):536-42. doi: 10.1136/bmj.327.7414.536.
Results Reference
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PubMed Identifier
15100612
Citation
Ballesteros J, Duffy JC, Querejeta I, Arino J, Gonzalez-Pinto A. Efficacy of brief interventions for hazardous drinkers in primary care: systematic review and meta-analyses. Alcohol Clin Exp Res. 2004 Apr;28(4):608-18. doi: 10.1097/01.alc.0000122106.84718.67.
Results Reference
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PubMed Identifier
11099429
Citation
Hungerford DW, Pollock DA, Todd KH. Acceptability of emergency department-based screening and brief intervention for alcohol problems. Acad Emerg Med. 2000 Dec;7(12):1383-92. doi: 10.1111/j.1553-2712.2000.tb00496.x.
Results Reference
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PubMed Identifier
15468746
Citation
Anderson PA, Grey SF, Nichols C, Parran TV Jr, Graham AV. Is screening and brief advice for problem drinkers by clergy feasible? A survey of clergy. J Drug Educ. 2004;34(1):33-40. doi: 10.2190/3QH2-VLWN-ELWM-KC67.
Results Reference
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PubMed Identifier
18077300
Citation
Babor TF, McRee BG, Kassebaum PA, Grimaldi PL, Ahmed K, Bray J. Screening, Brief Intervention, and Referral to Treatment (SBIRT): toward a public health approach to the management of substance abuse. Subst Abus. 2007;28(3):7-30. doi: 10.1300/J465v28n03_03.
Results Reference
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PubMed Identifier
10522717
Citation
Gentilello LM, Rivara FP, Donovan DM, Jurkovich GJ, Daranciang E, Dunn CW, Villaveces A, Copass M, Ries RR. Alcohol interventions in a trauma center as a means of reducing the risk of injury recurrence. Ann Surg. 1999 Oct;230(4):473-80; discussion 480-3. doi: 10.1097/00000658-199910000-00003.
Results Reference
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PubMed Identifier
16355071
Citation
Babor TF, Kadden RM. Screening and interventions for alcohol and drug problems in medical settings: what works? J Trauma. 2005 Sep;59(3 Suppl):S80-7; discussion S94-100. doi: 10.1097/01.ta.0000174664.88603.21.
Results Reference
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PubMed Identifier
12199834
Citation
WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.
Results Reference
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PubMed Identifier
15068985
Citation
Whitlock EP, Polen MR, Green CA, Orleans T, Klein J; U.S. Preventive Services Task Force. Behavioral counseling interventions in primary care to reduce risky/harmful alcohol use by adults: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2004 Apr 6;140(7):557-68. doi: 10.7326/0003-4819-140-7-200404060-00017.
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Citation
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Results Reference
background
Links:
URL
http://medicina.uc.cl
Description
Pontificia Universidad Católica de Chile, School of Medicine
URL
http://www.senda.gob.cl
Description
Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)
URL
http://medicinafamiliar.uc.cl
Description
Family Medicine Dept., Pontificia Universidad Católica de Chile, School of Medicine.

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"Effectiveness of a Brief Intervention for Substances Consumption Linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): A Randomized Control Trial in Chilean Primary Care."

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