<?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>IRCT20230303057598N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Emotion Efficacy Therapy on fear of negative evaluation, experiential avoidance, parental burnout and psychological hardiness among mothers with Autistic children</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Emotion Efficacy Therapy on Fear of Negative Evaluation, Experiential Avoidance, Parental Burnout and Psychological Hardiness among Mothers with Autistic Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68966</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The samples were identified by random block method and using random numbers table, Random Allocation Software. Blocking and allocation sequence for concealment was done by a person not involved in the research; Allocation Concealment.
Blocking: This method was used to avoid significant imbalances in the number of volunteers assigned to each group. Block randomization ensures that there is no significant imbalance between groups at any time during randomization, and that at certain points the number of participants in each group is equalized. For this purpose, the size of each block must be determined first (for example, a block of four), then write the list of blocks and assign numbers to them, then choose random numbers between 1 to 6 and finally determine the allocation of treatment based on the previous random numbers, in intervention group and control group, Blinding description: After receiving informed consent, the participants were randomly assigned to the intervention group. The volunteers may not have been aware of the main purpose of the research, but they only knew that they were   participating in a study that could improve their psychological problems. In addition, the data analyst did not know the content of the intervention sessions and was only aware of the assumptions, goals and questions of the research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>autism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: they were treated based on Emotion Efficacy Therapy (McKay and West, 2016) during 8 sessions of 120 minutes (two sessions per week). First session: Awareness of excitement. Session 2: Acceptance of the conscious mind, surfing on excitement. The third session: action based on values - first part. Fourth session: Action based on values - Part II. Fifth session: Mindful confrontation, calm body and self-soothing. Sixth session: conscious mind confrontation, confrontational thoughts, fundamental acceptance. Seventh session: Mindful confrontation, returning attention and rest time. Eighth session: Fixing, fixing bugs and summarizing. Intervention 2: Control group: a group that does not undergo any intervention. They only complete the questionnaires before and after the study. If they wish, they can undergo intervention after the end of the study.</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 data file of the participants can only be published in general without mentioning the names and addresses of the participants. The study protocol can also be published as a table. The statistical analysis map can be published in the form of tables and statistical results obtained. Informed consent can be published in its entirety. Applied research results can be published. Statistical methods and statistical analysis are publishable. The obtained data can be published in the form of tables. All items can be presented in accordance with the guidelines of the magazines and if there is no harm to the participants.

When:
The access period starts with the opinion and agreement of the relevant publications.

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
All cases of using documents will be possible with the permission of the university of study and professors related to the research and in compliance with the existing rules and regulations.

Where to obtain:
Reputable journals in which articles related to research are published. The e-mail of the supervisor and the student responsible for the project and their university website will be made available to the applicants to use the results in compliance with the rules and regulations and maintaining the confidentiality of the participants.

How to obtain:
If the rules related to research documents are followed, the request will be answered as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Golnaz Ahghar Bazargan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 85, fifth alley, South Sheikh Sadouq</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8168684611</zip>
        <telephone>+98 31 3668 1272</telephone>
        <email>bazargangolnaz6@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Golnaz Ahghar Bazargan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 85, fifth alley, South Sheikh Sadouq</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8168684611</zip>
        <telephone>+98 31 3668 1272</telephone>
        <email>bazargangolnaz6@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The minimum level of education
Mothers of Autistic children
Willingness to participate in the research and complete the research questionnaires completely
Absence of acute psychiatric disorders at the same time
Not having a child with another disorder besides ASD
Not taking part in other psychotherapy sessions simultaneously</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having two absent sessions in the intervention process
Having previous experience in therapy based on Emotion Efficacy Therapy
Having defects such as physical, sensory or cognitive that prevent participation in the study
Being under psychological treatment</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>Rehabilitation</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: they were treated based on Emotion Efficacy Therapy (McKay and West, 2016) during 8 sessions of 120 minutes (two sessions per week). First session: Awareness of excitement. Session 2: Acceptance of the conscious mind, surfing on excitement. The third session: action based on values - first part. Fourth session: Action based on values - Part II. Fifth session: Mindful confrontation, calm body and self-soothing. Sixth session: conscious mind confrontation, confrontational thoughts, fundamental acceptance. Seventh session: Mindful confrontation, returning attention and rest time. Eighth session: Fixing, fixing bugs and summarizing</i_keyword>
      <i_keyword>Control group: a group that does not undergo any intervention. They only complete the questionnaires before and after the study. If they wish, they can undergo intervention after the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of negative evaluation: The structure of fear of negative evaluation includes the feeling of apprehension and concern about the evaluations of others, the anxiety caused by these negative evaluations, and the expectation that others have about a person. Timepoint: At the beginning of the study, after the intervention and two months after the intervention. Method of measurement: Breaf Fear of Negative Evaluation Scale Larry (1983).</prim_outcome>
      <prim_outcome>Experiential avoidance: Attempts to change the form, frequency, or situational sensitivity of difficult personal events such as thoughts, feelings, and physiological sensations. Timepoint: At the beginning of the study, after the intervention and two months after the intervention. Method of measurement: Acceptance and Action Questionnaire-II Bund et al. (2011).</prim_outcome>
      <prim_outcome>Parental burnout: Parental burnout is defined as three dimensions of fatigue from the parental role, emotional distance from children, and loss of parental efficiency and performance. Timepoint: At the beginning of the study, after the intervention and two months after the intervention. Method of measurement: Parental Burnout Assessment Roskam et al. (2017).</prim_outcome>
      <prim_outcome>Psychological hardiness: Hardiness is a set of personality traits that protects a person against stressful life events, as one of the sources of resistance like a shield, and enables him to face internal and external challenges. Stubbornness is a combination of beliefs about oneself and the world, which consists of the three components of commitment, control, and struggle, and makes a person immune to external and internal pressures. Timepoint: At the beginning of the study, after the intervention and two months after the intervention. Method of measurement: Psychological Hardiness Kobasa (1989).</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>Isfahan Islamic Azad University (Khorasgan)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-30</approval_date>
        <contact_name>Research Committees of Islamic Azad University-Isfahan (Khorasgan) Branch</contact_name>
        <contact_address>No. 85, Fifth Alley, South Sheikh Sadouq St Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
