Development and evaluation an Intervention Program for Prevention of Substance Abuse Based on Multi Theory Model(MTM) (in sequential exploratory mixed-method )
Determining the effect of an educational intervention program based on Multi Theory Model on substance abuse prevention.
Design
Quantitative sampling is done in two steps. In instrument psychometric, a sample will be systematically selected randomly from the Morgan table. There is no blinding.
In the intervention section, the sample size will be 60 people and available sampling random assignment will be used.
Settings and conduct
In the qualitative phase, interviews will be conducted in the neighborhood mosque. Interviews are conducted as a focus group discussion.
In the quantitative phase of the study, the pre-test questionnaire will be completed by visiting the homes of the selected individuals.
Then the training program will be implemented and 6 months later the post-test questionnaires will be completed with the procedure of completing the pre-test stage. There is no blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Resident of the neighborhood, age group 15-50 years. Exclusion criteria: Addicted, mentally disabled and unable to cooperate
Intervention groups
The intervention group is trained based on the results of the qualitative stage and with the cooperation of experts who will determine the exact type and duration of the training. The intervention is done through an intervention group based on multi-theory model constructs at least 10 sessions in 6 months. The control group does not take any intervention, but after the end of the study, an educational package is provided to the control group.
Main outcome variables
Initiation of addictive preventive behaviors; Maintaining addiction-preventive behaviors; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200922048805N1
Registration date:2022-01-10, 1400/10/20
Registration timing:registered_while_recruiting
Last update:2022-01-10, 1400/10/20
Update count:0
Registration date
2022-01-10, 1400/10/20
Registrant information
Name
Nahid Ardian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 7659
Email address
n_ardian1382@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and evaluation an Intervention Program for Prevention of Substance Abuse Based on Multi Theory Model(MTM) (in sequential exploratory mixed-method )
Public title
Effectiveness of Interventional Program Based on Multi Theory Model on Prevention of Substance Abuse
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having lived in the neighborhood for at least two years
In the age group of 15 to 50 years old, immigrant or native, female or male
Exclusion criteria:
Addicted people (self-report )
People with mental disabilities or who unable to participate in the study
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using the stratified randomization method.
Samples are divided into control and intervention groups. In addition to sufficient accuracy in the conditions of inclusion criteria, homogenization is based on the variables of age and sex status.
Random allocation software is used for randomization. For concealment, we use allocation concealment, which is the method used to execute a random sequence on study participants, so that the assigned group is not known before the individual is assigned.
Using opaque envelopes sealed in a random sequence (Sequentially numbered, sealed, opaque envelopes) in which each of the random sequences created is recorded on a card and the cards are placed in the envelopes respectively.
In order to maintain a random sequence, the numbering on the outer surface of the envelopes is done in the same way. Finally, the letter envelopes are glued and placed in a box, respectively.
At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The present study is carried out by a sequential combination exploratory method including qualitative phase and quantitative phase, in which the intervention is performed in a quantitative phase.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comittee of Shahid Sadoughi University of Medical Sciences
Street address
School of Public Health, Shahid Sadoughi Univesity of Medical Sciences , Alem Squ - Shohadaye Gomnam Street, Yazd.Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.SSU.SPH.REC.1398.106
Health conditions studied
1
Description of health condition studied
Prevention of Substance Abuse Based on Multi Theory Model
ICD-10 code
F19.1
ICD-10 code description
Other psychoactive substance abuse
Primary outcomes
1
Description
Institutionalization of addiction prevention behaviors among people aged 15 to 50 years
Timepoint
Before and 6 months after the intervention in both groups, the behavior score is measured by completing a questionnaire.
Method of measurement
The score obtained from the designed questionnaire
Secondary outcomes
1
Description
Start preventive behavior from addiction
Timepoint
Before and 6 months after the intervention
Method of measurement
Research made Questionnaire
Intervention groups
1
Description
An intervention group is a group that is randomly selected from the participants and is trained based on the results of the qualitative stage and with the cooperation of experts who will determine the exact type and duration of the training. The content of the training is designed based on the structures of the multi-theory model on the prevention of substance abuse. Intervention group: The internship is done through group training of at least ten 90-minute sessions over 6 months and with appropriate methods (lectures, questions and answers and the use of educational videos).
Category
Prevention
2
Description
Control group: After the end of the study, three group training sessions are considered for the control group and the educational content is provided to them in the form of brochures and educational videos.
School of Pablic Health, Shahid Sdoughi university of medical sciences, Shohadaye Gomnam Blvd, Alem Squr
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
+98 35 3725 4750
Email
masoud_mirzaei@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
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
Yazd University of Medical Sciences
Full name of responsible person
Nahid Ardian
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Social Services
Street address
School of Health, Shahid Sadoughi University of Medical Sciences, َShohadaye Gomnam Blvd, Alem square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Fax
+98 35 3820 9119
Email
n_ardian1382@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nahid Ardian
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Social Services
Street address
Faculty of Health, Shohadaye Gomnam Street, Alam Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2179
Fax
+98 35 3820 9119
Email
n_ardian1382@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Saeed Mazloomi Mahmoodabad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, University of Medical Sciences, Shohada Gomnam St., Alam Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Fax
+98 35 3820 9119
Email
n_ardian1382@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data related to this research can be shared, such as information about the main result of the study. Of course, this information is done after the applicant's application is reviewed by the council at the University Vice Chancellor for Research. Also, the data will be provided to the applicants after the data owners are not identified.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data of this study are allowed after the permission of Shahid Sadoughi University of Medical Sciences for the analyzes that are to be performed on the data.
From where data/document is obtainable
Social determinants of Health Research Center, School of Health, Shahid Sadoughi University of Medical Sciences, Shohadae Gomnam Blvd, Alam Sq.
Dr. Seyed Saeed Mazloomy Mahmoodabad
0098 35 38209100
0098 9132506563
What processes are involved for a request to access data/document
The application should be sent to the address listed above in the box. After review, which takes about two to four weeks, the applicant will be contacted after coordination with the Vice-Chancellor for Research and Technology Affairs.