<?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>IRCT20210602051482N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-26</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Impact of Mothers Empowerment on Aggression of Children with Autism</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Impact of Mothers Empowerment on Aggression  score  of 6 – 12 Years Old Children  with Autism in Al- Nasiriya City at 2021</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56850</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method (entry of research participants from the community to the sample) will be non-random (convenient sampling). Mothers of children with autism in the Iraqi city of Nasiriyah are selected from special care centers for children with autism. The Iraqi city of Nasiriyah has two autistic children's centers. With a simple randomization method, lottery, one center will be assigned to the intervention group and another center to the control group. Then, for each of the intervention and control groups, 30 people from each center will be selected by lot, Blinding description: All the goals and methods of the study will be explained to the participants in the study when obtaining informed consent. Interventions and evaluations will also be performed by the researcher. Therefore, in this study, only the person responsible for data analysis can be blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: empowerment model in 4 stages Content: threat perception	(1) To increasing knowledge and awareness in association with the disease. In first session introduce with mothers and assessment problems with child’s autism. The researcher guides mothers to identify effective thoughts and feelings in stressful and aggressive situations for children. Problem solving (2) to increase participation in order to increase self-esteem and self-efficacy of the individual in coping with problems. Create a group discussion among the participants to exchange experiences (with the researcher's assistance) to solve problems. Educational participation (3) Participate the mothers in care giving. The researcher mothers the stressful conditions and the resulting changes in children with autism. The researcher teaches people to make positive mental changes. The researcher presents relaxation patterns in stressful and aggressive situations for children. Teaching stress management skills and how to deal with aggressive and stubbornness situations in children. The researcher teaches attention and focus techniques for autistic children. Training on the use of movement activities (such as playing a small ball, zigzag walking between cones) for children to direct the behavior towards a specific task and move from a random state to a purposeful state of behavior (Discharging the excess energy and random movements and employing them in purposeful, organized and positive activities). It reinforces and supports the desired behaviors of the aggressive child. Training skills on the acquired skills and the need to apply these skills when dealing with aggressive situations for autistic children provided presentations in the previous sessions were given to the mothers as CD-face-to-face training educational pamphlets. Evaluation (4) to determine learning rate and participation of the individuals. An evaluation at the end of each session and an evaluation also which will done finally. Intervention 2: Control group: For children in the control group in autistic children's centers in Nasiriyah, a series of pamphlets are delivered to parents that contain trainings such as the behaviors of these children and how to deal with it. They usually do not have classes and face-to-face meetings with their parents. These pamphlets will also be provided to the participants of the intervention group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Behnam vashani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad, Daneshgah St., Ibn Sina Crossroads</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3854 2022</telephone>
        <email>behnamhr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad, Daneshgah St., Ibn Sina Crossroads</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3854 2022</telephone>
        <email>sadeghit@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Their child has one of the types of autism, 
Children age between 6 to 12 years.
Lack of experience of a stressful event in the last six months.
Parents agreed with participation in the study.
The autistic child should not be diagnosed with other mental illnesses.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parents who have participated in other similar activities.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: empowerment model in 4 stages Content: threat perception	(1) To increasing knowledge and awareness in association with the disease. In first session introduce with mothers and assessment problems with child’s autism. The researcher guides mothers to identify effective thoughts and feelings in stressful and aggressive situations for children. Problem solving (2) to increase participation in order to increase self-esteem and self-efficacy of the individual in coping with problems. Create a group discussion among the participants to exchange experiences (with the researcher's assistance) to solve problems. Educational participation (3) Participate the mothers in care giving. The researcher mothers the stressful conditions and the resulting changes in children with autism. The researcher teaches people to make positive mental changes. The researcher presents relaxation patterns in stressful and aggressive situations for children. Teaching stress management skills and how to deal with aggressive and stubbornness situations in children. The researcher teaches attention and focus techniques for autistic children. Training on the use of movement activities (such as playing a small ball, zigzag walking between cones) for children to direct the behavior towards a specific task and move from a random state to a purposeful state of behavior (Discharging the excess energy and random movements and employing them in purposeful, organized and positive activities). It reinforces and supports the desired behaviors of the aggressive child. Training skills on the acquired skills and the need to apply these skills when dealing with aggressive situations for autistic children provided presentations in the previous sessions were given to the mothers as CD-face-to-face training educational pamphlets. Evaluation (4) to determine learning rate and participation of the individuals. An evaluation at the end of each session and an evaluation also which will done finally.</i_keyword>
      <i_keyword>Control group: For children in the control group in autistic children's centers in Nasiriyah, a series of pamphlets are delivered to parents that contain trainings such as the behaviors of these children and how to deal with it. They usually do not have classes and face-to-face meetings with their parents. These pamphlets will also be provided to the participants of the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aggressive behavior score  towards oneself.aggressive behavior score  towards others.aggressive behavior score  towards property. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: demographic data questionnaire and aggression questionnaire. This questionnaire would be an assessment tool for aggression of the children aged 6-12 years and consists of 40 questions that measure the dimensions of aggression, including aggression towards oneself, towards others and towards properties.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-27</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad, Ph.D. Crossroads, Mashhad School of Nursing and Midwifery, Ethics Committee Mashahd Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
