"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."

This study has been completed.
Sponsor:
Collaborator:
Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)
Information provided by (Responsible Party):
Fernando Poblete Arrué, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01573416
First received: April 5, 2012
Last updated: October 8, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Alcohol-Related Disorders
Substance-Related Disorders
Substance Abuse
Other: ASSIST-linked brief intervention for hazardous and harmful substance use.
Other: Observation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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."

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • Post-intervention ASSIST screening score. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 400
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573416

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

Additional Information:
Publications:

Responsible Party: Fernando Poblete Arrué, Profesor Asistente Adjunto, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01573416     History of Changes
Other Study ID Numbers: CEDAUC-11-205
Study First Received: April 5, 2012
Last Updated: October 8, 2013
Health Authority: Chile: Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA). Ministerio del Interior y Seguridad Publica

Keywords provided by Pontificia Universidad Catolica de Chile:
Alcohol
Abuse
Drugs
Brief intervention
ASSIST

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014