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Investigating the effectiveness of a brief intervention for alcohol and drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) on reducing substance use among 15- 18 years old drug users

Protocol summary

Study aim
Determining the effectiveness of a brief intervention for alcohol and drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) on reducing substance use among 15- 18 years old drug users in Yaran-e-Danesh va Mehr Association
Design
randomized control trial, without drug intervention on 54 participants. Simple randomization will be done by roll of die
Settings and conduct
Adolescents aged 15 to 18, members of Yaran Danesh and Mehr Association, after being invited to participate in the research and obtaining informed consent, completed the ASSIST screening test and, if they met the entry criteria, were randomly assigned to the intervention or control group, and three months after After receiving the brief intervention, they will be subjected to the ASSIST test to determine the effect of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria Research participants must be between the ages of 15 and 18, they and their legal guardians must have informed consent to participate in the research, and they must not be under the influence of drugs at the time of the intervention. Analysis of the ASSIST questionnaire. Exit criteria • Adolescents or their legal guardians withdraw from participating in the research
Intervention groups
The participants of the experimental group, in addition to receiving the usual services of the aforementioned association, receive a brief intervention related to ASSIST, which is based on motivational interviewing. The purpose of implementing this intervention is to increase motivation to change (reduce or stop drug use). However, participants assigned to the control group received no additional intervention beyond usual services.
Main outcome variables
Drug use among adolescents aged 15 to 18 years old

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220711055435N1
Registration date: 2023-05-29, 1402/03/08
Registration timing: registered_while_recruiting

Last update: 2023-05-29, 1402/03/08
Update count: 0
Registration date
2023-05-29, 1402/03/08
Registrant information
Name
Pegah Toofany
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7782 4938
Email address
pegahtoofany1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of a brief intervention for alcohol and drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) on reducing substance use among 15- 18 years old drug users
Public title
Investigating the effectiveness of a brief intervention for alcohol and drugs linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) on reducing substance use
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants must be at least 15 years old and at most 18 years old Participants and their legal guardians must give informed consent to participate in the research During the implementation of the intervention, adolescents should not be under the influence of drugs (this is checked based on clinical observation by a psychiatrist and social worker) Adolescents should obtain a medium and high risk score (score higher than 11) of drug use based on the analysis of the ASSIST questionnaire
Exclusion criteria:
Adolescents who obtain a low risk score (less than 11) of drug use based on the analysis of the ASSIST questionnaire
Age
From 15 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, simple randomization will be done by role of a die method for each person and they will be placed in one of two groups (intervention and control).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciencess
Street address
University of Rehabilitation Sciences and Social Health, Student Blvd, Evin,Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2022-11-23, 1401/09/02
Ethics committee reference number
IR.USWR.REC.1401.164

Health conditions studied

1

Description of health condition studied
substance use
ICD-10 code
(F10-F19)
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use

Primary outcomes

1

Description
Reducing substance use among 15- 18 years old drug users
Timepoint
Completing the ASSIST questionnaire before the intervention and three months after the first intervention
Method of measurement
ASSIST questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The Intervention group will receive ASSIST short-term intervention services in addition to usual services. The time required to implement the intervention for each person is 5 to 30 minutes, but it seems that in this research, at least 20 minutes of time is needed to implement this intervention. Three months after the intervention, the ASSIST screening test will be taken again (post-test) and the scores obtained in the pre-test and post-tests will be compared.
Category
Treatment - Other

2

Description
Control group: The control group will only receive the usual services at Yaran Danesh and Mehr Association, but will be tested twice in three months.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Yaran-e-Danesh va Mehr Association
Full name of responsible person
Peyman Qani-Zadeh
Street address
No. 11, Shahroud Alley, Khark Street, Hafez St., Shahryar St., Elkhebal St., Tehran
City
Tehran
Province
Tehran
Postal code
1133757511
Phone
+98 21 6671 7252
Email
info@aydm.org
Web page address
https://www.yaranedanesh.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Kianush Abdi
Street address
kodakyar Ave., daneshjo Blvd., Evin., Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Fax
+98 21 2218 0109
Email
pr@uswr.ac.ir
Web page address
https://uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Social Welfare and Rehabilitation Sciences
Full name of responsible person
Masoomeh Maarefvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Social Services
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2869
Email
ma.maarefvand@uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Pegah Toofany
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Social Services
Street address
No.36, Rahmati Alley, West Janbazan Ave, Narmak
City
Tehran
Province
Tehran
Postal code
1634718179
Phone
+98 21 7782 4938
Email
pegahtoofany1997@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Pegah Toofany
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Social Services
Street address
No.36, Rahmati Alley, West Janbazan Ave, Narmak
City
Tehran
Province
Tehran
Postal code
1634718179
Phone
+98 21 7782 4938
Email
pegahtoofany1997@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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