"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."

Phase 3

Completed

• Conditions: Alcohol-Related Disorders; Substance-Related Disorders; Substance Abuse
• Interventions: Other: Observation; Other: ASSIST-linked brief intervention for hazardous and harmful substance use.

• Registration Number: NCT01573416
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Status Verified: 2012-04
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-09
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Observation	-
Intervention group	ASSIST-linked brief intervention for hazardous and harmful substance use.	-

Primary Outcome Measures

Name	Time	Method
Post-intervention ASSIST screening score.	3 months	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.

Trial Locations

Locations (30)

CS Alberto Bachelet; 🇨🇱 Conchalí, RM, Chile

CESFAM Padre Gerardo Whelan; 🇨🇱 Peñalolén, RM, Chile

CESFAM Violeta Parra; 🇨🇱 Pudahuel, RM, Chile

SAPU La Estrella; 🇨🇱 Pudahuel, RM, Chile

APS Carol Urzúa; 🇨🇱 San Bernardo, RM, Chile

SAPU Raúl Brañes; 🇨🇱 San Bernardo, RM, Chile

CS Juanita Aguirre; 🇨🇱 Conchalí, RM, Chile

CS La Faena; 🇨🇱 Peñalolén, RM, Chile

APS Confraternidad; 🇨🇱 San Bernardo, RM, Chile

CESFAM San Juan; 🇨🇱 Coquimbo, IV, Chile

CESFAM Tierras Blancas; 🇨🇱 Coquimbo, IV, Chile

5ta. Comisaría Conchalí; 🇨🇱 Conchalí, RM, Chile

SAPU Lo Hermida; 🇨🇱 Peñalolén, RM, Chile

CESFAM Gustavo Molina; 🇨🇱 Pudahuel, RM, Chile

CESFAM RAúl Silva Henríquez; 🇨🇱 Pudahuel, RM, Chile

APS El Manzano; 🇨🇱 San Bernardo, RM, Chile

CESFAM Santa Cecilia; 🇨🇱 Coquimbo, IV, Chile

APS Raúl Cuevas; 🇨🇱 San Bernardo, RM, Chile

CS José Symon Ojeda; 🇨🇱 Conchalí, RM, Chile

43va. Comisaría Peñalolén; 🇨🇱 Peñalolén, RM, Chile

CS Carol Urzúa Ibañez; 🇨🇱 Peñalolén, RM, Chile

26va. Comisaría Pudahuel; 🇨🇱 Pudahuel, RM, Chile

Consultorio Estrella; 🇨🇱 Pudahuel, RM, Chile

SAPU Dr. Sergio Aguilar; 🇨🇱 Coquimbo, IV, Chile

CESFAM Lo Hermida; 🇨🇱 Peñalolén, RM, Chile

14va. Comisaría San Bernardo; 🇨🇱 San Bernardo, RM, Chile

CESFAM Dr. Sergio Aguilar; 🇨🇱 Coquimbo, IV, Chile

SAPU Tierras Blancas; 🇨🇱 Coquimbo, IV, Chile

SAPU Lucas Sierra; 🇨🇱 Conchalí, RM, Chile

CS Lucas Sierra; 🇨🇱 Conchalí, RM, Chile