"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."

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Alcohol-Related Disorders; Substance Abuse
• Intervention / Treatment: Other: Observation; Other: ASSIST-linked brief intervention for hazardous and harmful substance use.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control group	Other: Observation; 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.
ACTIVE_COMPARATOR: Intervention group	Other: ASSIST-linked brief intervention for hazardous and harmful substance use.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Collaborators: Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)
• Investigators: Study Director: Fernando Poblete, MD, MPH, Pontificia Universidad Catolica de Chile

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Hawks D. Broadening the base of treatment for alcohol problems: a report which deserves to be debated. The limits of treatment and importance of prevention. Br J Addict. 1991 Jul;86(7):848-9. doi: 10.1111/j.1360-0443.1991.tb01836.x. No abstract available.

Helpful Links

• Pontificia Universidad Católica de Chile, School of Medicine
• Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)
• Family Medicine Dept., Pontificia Universidad Católica de Chile, School of Medicine.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: April 5, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (ESTIMATE): April 9, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 9, 2013
• Last Update Submitted That Met QC Criteria: October 8, 2013
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: ASSIST; Alcohol; Brief intervention; Drugs; Abuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Alcohol-Related Disorders
• Other Study ID Numbers: CEDAUC-11-205