"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."

NCT01573416 | Completed Phase 3

• 1 other identifier: CEDAUC-11-205
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 30

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.

Conditions

Alcohol-Related Disorders; Substance-Related Disorders; Substance Abuse

Keywords

Alcohol; Abuse; Drugs; Brief intervention; ASSIST

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

Other: Observation

Intervention group

ACTIVE COMPARATOR

Other: ASSIST-linked brief intervention for hazardous and harmful substance use.

Interventions

ASSIST-linked brief intervention for hazardous and harmful substance use. OTHER

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 group

Observation OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA): collaborator

Study Sites (30)

CESFAM Dr. Sergio Aguilar

Coquimbo, IV, Chile

Location

CESFAM San Juan

Coquimbo, IV, Chile

Location

CESFAM Santa Cecilia

Coquimbo, IV, Chile

Location

CESFAM Tierras Blancas

Coquimbo, IV, Chile

Location

SAPU Dr. Sergio Aguilar

Coquimbo, IV, Chile

Location

SAPU Tierras Blancas

Coquimbo, IV, Chile

Location

5ta. Comisaría Conchalí

Conchalí, RM, Chile

Location

CS Alberto Bachelet

Conchalí, RM, Chile

Location

CS José Symon Ojeda

Conchalí, RM, Chile

Location

CS Juanita Aguirre

Conchalí, RM, Chile

Location

CS Lucas Sierra

Conchalí, RM, Chile

Location

SAPU Lucas Sierra

Conchalí, RM, Chile

Location

43va. Comisaría Peñalolén

Peñalolén, RM, Chile

Location

CESFAM Lo Hermida

Peñalolén, RM, Chile

Location

CESFAM Padre Gerardo Whelan

Peñalolén, RM, Chile

Location

CS Carol Urzúa Ibañez

Peñalolén, RM, Chile

Location

CS La Faena

Peñalolén, RM, Chile

Location

SAPU Lo Hermida

Peñalolén, RM, Chile

Location

26va. Comisaría Pudahuel

Pudahuel, RM, Chile

Location

CESFAM Gustavo Molina

Pudahuel, RM, Chile

Location

CESFAM RAúl Silva Henríquez

Pudahuel, RM, Chile

Location

CESFAM Violeta Parra

Pudahuel, RM, Chile

Location

Consultorio Estrella

Pudahuel, RM, Chile

Location

SAPU La Estrella

Pudahuel, RM, Chile

Location

14va. Comisaría San Bernardo

San Bernardo, RM, Chile

Location

APS Carol Urzúa

San Bernardo, RM, Chile

Location

APS Confraternidad

San Bernardo, RM, Chile

Location

APS El Manzano

San Bernardo, RM, Chile

Location

APS Raúl Cuevas

San Bernardo, RM, Chile

Location

SAPU Raúl Brañes

San Bernardo, RM, Chile

Location

Related Publications (12)

• 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.

  PMID: 22126102 BACKGROUND

• 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.

  PMID: 12958114 BACKGROUND

• 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.

  PMID: 15100612 BACKGROUND

• 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.

  PMID: 11099429 BACKGROUND

• 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.

  PMID: 15468746 BACKGROUND

• 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.

  PMID: 18077300 BACKGROUND

• 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.

  PMID: 10522717 BACKGROUND

• 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.

  PMID: 16355071 BACKGROUND

• 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.

  PMID: 12199834 BACKGROUND

• 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.

  PMID: 15068985 BACKGROUND

• 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.

  PMID: 1912733 BACKGROUND

• Greene MC, Kane J, Alto M, Giusto A, Lovero K, Stockton M, McClendon J, Nicholson T, Wainberg ML, Johnson RM, Tol WA. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries. Cochrane Database Syst Rev. 2023 May 9;5(5):CD013350. doi: 10.1002/14651858.CD013350.pub2.

  PMID: 37158538 DERIVED

Related 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.

MeSH Terms

Conditions

Alcohol-Related Disorders; Substance-Related Disorders; Helping Behavior

Interventions

Observation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Fernando Poblete, MD, MPH

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Asistente Adjunto

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 9, 2012
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 9, 2013

Record last verified: 2012-04

Locations

CL (30)