<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200922048805N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-10</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Interventional Program Based on Multi Theory Model on Prevention of Substance Abuse</public_title>
      <acronym></acronym>
      <scientific_title>Development and evaluation an Intervention Program for Prevention of Substance Abuse Based on Multi Theory Model(MTM)  (in sequential exploratory mixed-method )</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>280</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51162</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prevention of Substance Abuse Based on Multi Theory Model.</hc_freetext>
      <i_freetext>Intervention 1: 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). Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
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 access period starts 6 months after the results are published.

To whom:
The data will be available to researchers working in academic and scientific institutions.

Conditions:
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.

Where to obtain:
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

How to obtain:
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.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Ardian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Health, Shahid Sadoughi University of Medical Sciences, َShohadaye Gomnam Blvd, Alem square, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3820 9100</telephone>
        <email>n_ardian1382@hotmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Ardian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Health, Shohadaye Gomnam Street, Alam Square, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3149 2179</telephone>
        <email>n_ardian1382@hotmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Addicted people (self-report )
People with mental disabilities or who unable to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F19.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other psychoactive substance abuse</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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).</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Start preventive behavior from addiction. Timepoint: Before and 6 months after the intervention. Method of measurement: Research made Questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-12</approval_date>
        <contact_name>Ethic comittee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>School of Public Health, Shahid Sadoughi Univesity of Medical Sciences , Alem Squ - Shohadaye Gomnam Street, Yazd.Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
