"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."

Substance-Related Disorders Clinical Trial

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."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573416
• Other study ID #: CEDAUC-11-205
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2012
• Last updated: October 8, 2013
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2012
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA). Ministerio del Interior y Seguridad Publica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Disease
• Substance Abuse
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
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	Conchalí	RM
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	Coquimbo	IV
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	Peñalolén	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	Pudahuel	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	San Bernardo	RM

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Servicio Nacional para la Prevención y Rehabilitación del Consumo de Drogas y Alcohol (SENDA)

Country where clinical trial is conducted

Chile, 

References & Publications (11)

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. — View 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. — View 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. Review. — View Citation

Ballesteros J, Duffy JC, Querejeta I, Ariño J, González-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. Review. — View 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. Review. — View 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. — View Citation

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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

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