<?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>IRCT20180924041110N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-22</date_registration>
      <primary_sponsor>Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of time-use training on stress in mothers of Children with intellectual disability</public_title>
      <acronym>ID</acronym>
      <scientific_title>The effect of time-use training on stress in mothers of Children with intellectual disability Tehran 2017</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34019</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: To collect the data, researcher first randomly selected two schools from an educational district and randomly assigned one of the schools to the experimental group and the other to the control group. First, the researcher, in collaboration with the health trainer and the school principal, reviewed the files in the school. Then, according to the criteria for entering the research, the samples were selected based on the goal and were invited to the school. It should be noted that the control group was separated from the two schools, which was done simultaneously at intervals of one day, Blinding description: The study was conducted in two separate schools. The control group was a school and a experimental group was  other school so the two groups did not know.</study_design>
      <phase>3</phase>
      <hc_freetext>Intellectual disability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At first, 96 mothers (48 in the experimental group and 48 in the control group) had mentally disabled children in the study, of which 16 (8 from each group) according to the criteria for withdrawal And completion of the questionnaire was excluded and finally 80 subjects were included in the study. In the intervention group, which was a girls' school in west of Tehran, after receiving written consent, questionnaires were distributed to mothers for completion. Maternity Use Questionnaire and Resource &amp; Stress Questionnaire. After completing the questionnaire, a 6-hour workshop was held on optimal use of time. Lecture methods, questions and answers, educational slideshows, training for the optimal use of time, including introduction, definitions, concepts, principles and rules of time management, time management barriers, and the ways to deal with time lagers as well as control Time stress, questions and answers were presented at the workshop, and educational pamphlet broadcasting related to the research topic was held. After 6 weeks, they returned to the school and distributed the questionnaires. Intervention 2: Control group:  At first, 96 mothers (48 in the experimental group and 48 in the control group) had mental retardation in the girl who were included in the study; 16 of them (8 from each group) according to the criteria for withdrawal And completion of the questionnaire was excluded. Finally, 80 subjects were enrolled in the study. In the control group, the girl's school was in the west of Tehran and the school was separate from the intervention group school. After obtaining written consent, the questionnaires were distributed to mothers. Maternity Use Questionnaire and Resource &amp; Stress Questionnaire. After 6 weeks, they returned to the school again and the questionnaires were returned to their mothers. Then they presented educational pamphlets.</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:
The number of participants and result of the intervention after training

When:
Get access after  6 months after publish

To whom:
researcher

Conditions:
Documentation is available on table of spss

Where to obtain:
corresponding  author

How to obtain:
by email to corresponding  author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Meimanat Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SBMU School of Nursing &amp; Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>meimanathosseini@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Meimanat Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr Ave., Niayesh Cross Road, Niayesh Complex</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>meimanathosseini@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have a nuclear family.
Have a mentally disabled child.
Other children of the family are not suffering from chronic physical or mental illness.
An Inferior, Mental, Educable Child (with an IQ of 70-50).
A mentally disabled child is at school age (6 to 13 years).
Mother-careful mother is a disabled child.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>13 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lack of participation in the time use training program
Cancellation of the study due to unwillingness
The presence of problems associated with mental disability, such as blindness, deafness and certain diseases in the child
Child care carers have the responsibility to take care of another person with a disability in their families or relatives</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F10-F19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioral disorders due to psychoactive substance use</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: At first, 96 mothers (48 in the experimental group and 48 in the control group) had mentally disabled children in the study, of which 16 (8 from each group) according to the criteria for withdrawal And completion of the questionnaire was excluded and finally 80 subjects were included in the study. In the intervention group, which was a girls' school in west of Tehran, after receiving written consent, questionnaires were distributed to mothers for completion. Maternity Use Questionnaire and Resource &amp; Stress Questionnaire. After completing the questionnaire, a 6-hour workshop was held on optimal use of time. Lecture methods, questions and answers, educational slideshows, training for the optimal use of time, including introduction, definitions, concepts, principles and rules of time management, time management barriers, and the ways to deal with time lagers as well as control Time stress, questions and answers were presented at the workshop, and educational pamphlet broadcasting related to the research topic was held. After 6 weeks, they returned to the school and distributed the questionnaires.</i_keyword>
      <i_keyword>Control group:  At first, 96 mothers (48 in the experimental group and 48 in the control group) had mental retardation in the girl who were included in the study; 16 of them (8 from each group) according to the criteria for withdrawal And completion of the questionnaire was excluded. Finally, 80 subjects were enrolled in the study. In the control group, the girl's school was in the west of Tehran and the school was separate from the intervention group school. After obtaining written consent, the questionnaires were distributed to mothers. Maternity Use Questionnaire and Resource &amp; Stress Questionnaire. After 6 weeks, they returned to the school again and the questionnaires were returned to their mothers. Then they presented educational pamphlets.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: 6 weeks. Method of measurement: ‘Resources and stress questionnaire’.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stress score. Timepoint: 6 weeks. Method of measurement: Resource and stress 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>Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-04</approval_date>
        <contact_name>دانشگاه علوم پزشکي شهيد بهشتي</contact_name>
        <contact_address>School of Nursing &amp; Midwifery, Vali Asr Ave., Niayesh Cross Road tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
