<?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>IRCT20231223060502N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-18</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of the Effectiveness of Brief Intervention on Harmful Cannabis Use in Teenagers and Young Adults</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the Effectiveness of Brief Intervention on Harmful Cannabis Use in Teenagers and Young Adults: A randomized controlled  clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74593</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Patients are divided into two groups: intervention and control. This division is done using the block randomization method, containing 12 blocks and a block size of 4. The methodologies used to determine block randomization using the online software http://www.sealedenvelope.com are as follows:

The sequence is BBAA, BABA, BBAA, BBAA, AABB, ABBA, BBAA, ABBA, BBAA, ABBA, ABBA, BBAA.

Random allocation is performed by a psychiatric resident (researcher) using a sealed envelope, Blinding description: For blinding, for the final evaluation, self-reported questionnaires are used by the patients so that the researcher does not influence the research results. Also, a person different from the psychiatry resident who performed the interventions will perform the final evaluation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Harmful Cannabis Use.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, the common treatment method for cannabis use disorders, which is a psycho educational interview, is performed for the intervention group or experiment, and then they are treated with a brief intervention method (short-term intervention). Brief intervention is done to identify current or potential drug use problems and motivate people at risk to change drug use behavior. Brief interventions in primary care can be from 5 minutes of brief advice to 15 to 30 minutes of brief counseling. The components of brief intervention are: 1- Feedback (Feedback) 2- Responsibility (Responsibility) 3- Advice (Advice) 4- Change options menu (Menu of alternative change options) 5- Empathy 6- Self-efficacy. Intervention 2: Control group: Control group: The control group is subjected to the usual treatment of cannabis use disorders, which is the psychoeducational interview.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Compliance with ethical principles and preventing the publication of personal and private information of patients</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Farazi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa Hospital, Dr heshmat Cross, Dr Shahid Beheshti Blvd</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41936-55599</zip>
        <telephone>+98 13 3366 2350</telephone>
        <email>shafahospitalrasht@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Farazi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa Hospital, Dr heshmat Cross, Dr Shahid Beheshti Blvd</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41936-55599</zip>
        <telephone>+98 13 3366 2350</telephone>
        <email>zahrafarazimoghadam@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Speak Persian
Be between 15 and 24 years old
Have the ability to read and write in Farsi language
The current consumers of cannabis and its derivatives include flowers, hashish, hashish oil, etc.
According to the ASSIST test, be in the medium-risk group (a score in the range of 4-26)
Do not use any other drugs except cannabis (cigarettes and alcohol are excluded)
Consent to participate in the research</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>24 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient is psychotic
Be in the acute phase of mania
Have cognitive impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F12.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioral disorders due to use of cannabinoids : harmful us</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, the common treatment method for cannabis use disorders, which is a psycho educational interview, is performed for the intervention group or experiment, and then they are treated with a brief intervention method (short-term intervention). Brief intervention is done to identify current or potential drug use problems and motivate people at risk to change drug use behavior. Brief interventions in primary care can be from 5 minutes of brief advice to 15 to 30 minutes of brief counseling. The components of brief intervention are: 1- Feedback (Feedback) 2- Responsibility (Responsibility) 3- Advice (Advice) 4- Change options menu (Menu of alternative change options) 5- Empathy 6- Self-efficacy</i_keyword>
      <i_keyword>Control group: Control group: The control group is subjected to the usual treatment of cannabis use disorders, which is the psychoeducational interview</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of cannabis use based on the ASSIST questionnaire. Timepoint: Upon arrival - 3 months of intervention - 3 months after intervention. Method of measurement: ASSIST questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Motivation and willingness to reduce and quit cannabis use and ASSIST score. Timepoint: Upon arrival - 3 months of intervention - 3 months after intervention. Method of measurement: Motivation Ruler for Leaving Drugs and  ASSIST 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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-29</approval_date>
        <contact_name>Ethics committee of Gilan University of Medical Sciences</contact_name>
        <contact_address>Guilan University of Medical Sciences' Headquarters - Parastar St. - Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
