<?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>IRCT2013010812053N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-03-16</date_registration>
      <primary_sponsor>Tehran Psychiatric Institute, Mental Health Research Center, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>declining the problems of autistic children and therir parents with parent psychoeducation</public_title>
      <acronym></acronym>
      <scientific_title>The study of group parental training about autism and behavioral management of children on mental health of parent and behavioral problems of their children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12193</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>autistic disorder.</hc_freetext>
      <i_freetext>parents of intervention group should participate in 10 sesssions of parental training according to Taung(2006). it appears that participation of control group in 10 weeks without any clear content is not etical, so they will be seen in 3 sessions (before and after and 3 months later) to fill questionaire.        &#13;
. Each session lasts 90 minutes.  Content of sessions are:&#13;
 Session 1: introduction&#13;
 Goals of the intervention; group rules; talking about autism&#13;
    Session 2: problems of parents after diagnosis&#13;
Reaction to diagnosis; stress and dealing with it&#13;
    Session 3: identifying and management of behavioral problems&#13;
What is behavioral management? How do the parents start it?&#13;
    Session 4: how can we change inappropriate behavior with modifying the consequences?&#13;
Positive rewards, extinction, punishment&#13;
    Session 5: how do we reinforce new behavior?&#13;
  Giving feedback; shaping new behavior&#13;
    Session 6: communication problems in autistic children that can talk&#13;
How these problems do affect on their behavior?&#13;
    Session 7: communication problems in autistic children that cannot talk&#13;
How do these problems affect on their behavior? Improving nonverbal communication; how can we reinforce communication? How can we start communication? (Some ideas to start interaction with young children)&#13;
    Session 8: social problems in autistic children&#13;
Therapeutic approach for young children; Therapeutic approach for older children and adolescent&#13;
    Session 9: playing and working with others&#13;
The importance of playing; how do you attract your child's attention? Increasing eye contact, paying and sustaining attention on a task, recalling&#13;
    Session 10: evaluating and criticizing all previous sessions.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hakim Shooshtari Mitra</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mansouri street, Niayesh street, Sattar khan Avenue, Tehran psychiatric Institute and Mental Health Research Center, Mail Code: 1443813444</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6650 9024</telephone>
        <email>mitra.hakim@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences, Mental Health Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hakim Shooshtari mitra</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mansouri street, Niayesh street, sattar khan Avenue, Tehran Psychiatric Institute and Mental Health Research Center, Mail Code: 1443813444</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1443813444</zip>
        <telephone>+98 21 6650 9024</telephone>
        <email>mitra.hakim@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria:  the parents with a child affected by autistic disorder in preschool or school age; no participation in other parent training group</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Childhood autism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>parents of intervention group should participate in 10 sesssions of parental training according to Taung(2006). it appears that participation of control group in 10 weeks without any clear content is not etical, so they will be seen in 3 sessions (before and after and 3 months later) to fill questionaire.        &#13;
. Each session lasts 90 minutes.  Content of sessions are:&#13;
 Session 1: introduction&#13;
 Goals of the intervention; group rules; talking about autism&#13;
    Session 2: problems of parents after diagnosis&#13;
Reaction to diagnosis; stress and dealing with it&#13;
    Session 3: identifying and management of behavioral problems&#13;
What is behavioral management? How do the parents start it?&#13;
    Session 4: how can we change inappropriate behavior with modifying the consequences?&#13;
Positive rewards, extinction, punishment&#13;
    Session 5: how do we reinforce new behavior?&#13;
  Giving feedback; shaping new behavior&#13;
    Session 6: communication problems in autistic children that can talk&#13;
How these problems do affect on their behavior?&#13;
    Session 7: communication problems in autistic children that cannot talk&#13;
How do these problems affect on their behavior? Improving nonverbal communication; how can we reinforce communication? How can we start communication? (Some ideas to start interaction with young children)&#13;
    Session 8: social problems in autistic children&#13;
Therapeutic approach for young children; Therapeutic approach for older children and adolescent&#13;
    Session 9: playing and working with others&#13;
The importance of playing; how do you attract your child's attention? Increasing eye contact, paying and sustaining attention on a task, recalling&#13;
    Session 10: evaluating and criticizing all previous sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Family assessment. Timepoint: pre and post intervention and 3 months later. Method of measurement: Family Assessment Device.</prim_outcome>
      <prim_outcome>Coping mechanism. Timepoint: pre and post intervention and 3 months later. Method of measurement: The Billings and Moos coping checklist (1981).</prim_outcome>
      <prim_outcome>General health. Timepoint: pre and post intervention and 3 months later. Method of measurement: General Health Questionnaire of Goldberg.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Social communication. Timepoint: pre and post intervention and 3 months later. Method of measurement: social communication questionnaire.</sec_outcome>
      <sec_outcome>Childhood autism. Timepoint: pre and post intervention and 3 months later. Method of measurement: childhood autism rating scale.</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>Tehran Psychiatric Institute, Mental Health Research Center, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-12-15</approval_date>
        <contact_name>Tehran University of Medical Sciences, Mental Health Research Center of tehran psychitric institute</contact_name>
        <contact_address>Tehran, Islamic Revolution, Ghods Street, Tehran University of Medical Sciences and Health Services, Postal Code: 1417614411 Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
