<?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>IRCT20230423057978N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-19</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  Adolescent-Community Reinforcement Approach on Cannabis Use</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Adolescent-Community Reinforcement Approach on Treatment Outcome Among Adolescents with Cannabis Use Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69808</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cannabis Use Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Treatment by Adolescent- Community Reinforcement Approach that includes 12 one-hour individual sessions with adolescents and 2 sessions with caregivers (parents) and 2 joint sessions between caregivers (parents) and adolescents. These meetings are held weekly over a period of 12 to 14 weeks. The duration of the sessions can be changed based on the needs of the adolescent or caregiver or the discretion of the therapist. This program has 19 procedures that the therapist chooses the appropriate procedure according to the client's needs during the implementation of the intervention. Intervention procedures and case management activities include functional analysis of substance use or prosocial behaviors, self-assessment of happiness, counseling goals, planning for socially acceptable recreation, relapse prevention skills, communication skills, problem solving skills, family relationship skills (such as problem solving, communication and happy relationships), setting homework, homework review, finding a job skills,  anger management, crisis intervention, communication skills in caregivers, parent-adolescent communication skills, systematic encouragement and urine testing. Adolescents who receive 10 or more of these procedures during their treatment and attend at least 7 treatment sessions are more likely to stay in recovery for a long time. Intervention 2: Control group: Treatment as usual that include psychoeducation about substance use and behavioral techniques for managing cravings and teaching coping strategies. Adolescents participate in at least 5 , 45-minute therapy sessions weekly. Based on the client's needs and the therapist's discretion, the number of sessions can be increased up to 8 sessions. The treatment period will last between 5 and 8 weeks.</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 It is possible to misuse individual raw data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Khosrovanmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 89, 3rd Andishe Alley, North Sohrevardi</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1569637811</zip>
        <telephone>+98 21 8843 0847</telephone>
        <email>nkhosrovan@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Najmeh Khosrovanmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 89, 3rd Andishe Alley,  North Sohrevardi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1569637811</zip>
        <telephone>+98 21 8843 0847</telephone>
        <email>khosrovanmehr.n@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a cannabis use disorder
Being in the age range of 15 to 19 years old</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>19 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>having psychotic symptoms
having Autism Spectrum Disorder
Having Bipolar and Related Disorders
Intellectual Disability
Abusing Opioid and Stimulant substances</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F12.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cannabis dependence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Treatment by Adolescent- Community Reinforcement Approach that includes 12 one-hour individual sessions with adolescents and 2 sessions with caregivers (parents) and 2 joint sessions between caregivers (parents) and adolescents. These meetings are held weekly over a period of 12 to 14 weeks. The duration of the sessions can be changed based on the needs of the adolescent or caregiver or the discretion of the therapist. This program has 19 procedures that the therapist chooses the appropriate procedure according to the client's needs during the implementation of the intervention. Intervention procedures and case management activities include functional analysis of substance use or prosocial behaviors, self-assessment of happiness, counseling goals, planning for socially acceptable recreation, relapse prevention skills, communication skills, problem solving skills, family relationship skills (such as problem solving, communication and happy relationships), setting homework, homework review, finding a job skills,  anger management, crisis intervention, communication skills in caregivers, parent-adolescent communication skills, systematic encouragement and urine testing. Adolescents who receive 10 or more of these procedures during their treatment and attend at least 7 treatment sessions are more likely to stay in recovery for a long time.</i_keyword>
      <i_keyword>Control group: Treatment as usual that include psychoeducation about substance use and behavioral techniques for managing cravings and teaching coping strategies. Adolescents participate in at least 5 , 45-minute therapy sessions weekly. Based on the client's needs and the therapist's discretion, the number of sessions can be increased up to 8 sessions. The treatment period will last between 5 and 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Substance use problem. Timepoint: Before intervention, Immediately After Intervention, 3 Months after intervention. Method of measurement: Substance Problem Scale.</prim_outcome>
      <prim_outcome>Abstinence Rate. Timepoint: Before intervention, Immediately After Intervention, 3 Months after intervention. Method of measurement: Urine Test Kit for Cnnabis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Psychological symptoms ( Depression, Anxiety, Stress). Timepoint: Before intervention, Immediately after intervention, 3 Months after intervention. Method of measurement: Depression Anxiety Stress Scale.</sec_outcome>
      <sec_outcome>Parent- child  interaction. Timepoint: Before intervention, Immediately after intervention, 3 Months after intervention. Method of measurement: Parent - Child Interaction Scale.</sec_outcome>
      <sec_outcome>Health promoted life style. Timepoint: Before intervention, Immediately after intervention, 3 Months after intervention. Method of measurement: Health promoted life style Questionnaire.</sec_outcome>
      <sec_outcome>Retention. Timepoint: Immediately after intervention. Method of measurement: The total number of days from the start of treatment to the last treatment session.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-02</approval_date>
        <contact_name>Research Ethics Committees of Iran University of of Medical Sciences</contact_name>
        <contact_address>Research and Technology Vice-Chancellor, Central Headquarters Building, Hemat Highway, next to Milad Tower Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
