<?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>IRCT20220610055124N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-29</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The impact of group-based training using acceptance and commitment therapy on self-esteem and perceived stress.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the impact of group-based training using acceptance and commitment therapy on self-esteem and perceived stress in mothers of children with attention deficit/hyperactivity disorder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69735</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be selected through convenience sampling and then allocated to two groups, intervention (A) and control (B), using block randomization. For this purpose, blocks of four will be created from the combination of AABB, and blocks will be randomly selected until the sample size is complete.
Mersenne Twister will be used as the randomization tool.</study_design>
      <phase>N/A</phase>
      <hc_freetext>attention deficit hyperactivity disorder, self-esteem, perceived stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 25 participants will participate in eight 90-minute group sessions (one session per week) based on acceptance and commitment therapy. The content of the sessions is as follows: * Session one: Pre-test implementation (Eysenck self-esteem questionnaire and perceived stress scale), introducing the research topic to group members, an introduction to attention deficit/hyperactivity disorder and its effects on parents and family members, and the impact of psychological treatments on it. * Session two: Examining the external and internal world in acceptance and commitment-based therapy/challenging control strategies. * Session three: Identifying personal values, clarifying values, specifying goals, specifying actions and obstacles/extracting the experience that control is a problem. * Session four: Reviewing values and deepening previous concepts/defusing from depressing thoughts and feelings. * Session five: Understanding fusion and defusion and doing exercises for defusion/measuring participants' ability to defusion. * Session six: Understanding self-conceptualized fusion and teaching how to defuse from it. * Session seven: Mindfulness and emphasis on being in the present moment/importance of values. * Session eight: Reviewing life story and committing to action/reflecting on the progress made and the ongoing goals of the participants, post-test implementation (Eysenck self-esteem questionnaire and perceived stress scale). After three months, the participants will be re-evaluated using the Eysenck self-esteem questionnaire and perceived stress scale in the follow-up phase. Intervention 2: Control group: At the beginning of the study, these participants (25 individuals) will participate in the pre-test (Eysenck self-esteem questionnaire and perceived stress scale) and will not receive any intervention during the group-based acceptance and commitment therapy phase. At the end of the group-based therapy for the intervention group, these individuals will also participate in the post-test (Eysenck Self-Esteem Questionnaire and Perceived Stress Scale). After three months, the participants will be re-evaluated using the Eysenck self-esteem questionnaire and perceived stress scale in the follow-up phase.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahya Mojahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychiatry, Imam Reza Hospital, Taleghani St., Birjand, Iran</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717855659</zip>
        <telephone>+98 56 3242 3335</telephone>
        <email>mojahedi.m@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahya Mojahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychiatry, Imam Reza Hospital, Taleghani St., Birjand, Iran City</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717855659</zip>
        <telephone>+98 56 3242 3335</telephone>
        <email>mojahedi.m@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a child aged 7 to 12 years with attention deficit/hyperactivity disorder
The education level higher than diploma
Informed consent to participate in the study
Not having any known psychiatric disorder
Not having any disabilities or physical and mental illness that would prevent participation.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Receiving psychotropic medications in the past three months
Participating in psychological treatment and training courses in the past three months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, combined type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 25 participants will participate in eight 90-minute group sessions (one session per week) based on acceptance and commitment therapy. The content of the sessions is as follows: * Session one: Pre-test implementation (Eysenck self-esteem questionnaire and perceived stress scale), introducing the research topic to group members, an introduction to attention deficit/hyperactivity disorder and its effects on parents and family members, and the impact of psychological treatments on it. * Session two: Examining the external and internal world in acceptance and commitment-based therapy/challenging control strategies. * Session three: Identifying personal values, clarifying values, specifying goals, specifying actions and obstacles/extracting the experience that control is a problem. * Session four: Reviewing values and deepening previous concepts/defusing from depressing thoughts and feelings. * Session five: Understanding fusion and defusion and doing exercises for defusion/measuring participants' ability to defusion. * Session six: Understanding self-conceptualized fusion and teaching how to defuse from it. * Session seven: Mindfulness and emphasis on being in the present moment/importance of values. * Session eight: Reviewing life story and committing to action/reflecting on the progress made and the ongoing goals of the participants, post-test implementation (Eysenck self-esteem questionnaire and perceived stress scale). After three months, the participants will be re-evaluated using the Eysenck self-esteem questionnaire and perceived stress scale in the follow-up phase.</i_keyword>
      <i_keyword>Control group: At the beginning of the study, these participants (25 individuals) will participate in the pre-test (Eysenck self-esteem questionnaire and perceived stress scale) and will not receive any intervention during the group-based acceptance and commitment therapy phase. At the end of the group-based therapy for the intervention group, these individuals will also participate in the post-test (Eysenck Self-Esteem Questionnaire and Perceived Stress Scale). After three months, the participants will be re-evaluated using the Eysenck self-esteem questionnaire and perceived stress scale in the follow-up phase.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The average score that the participants will obtain from the Eysenck self-esteem questionnaire. Timepoint: Before and immediately after and 3 months after intervention. Method of measurement: Eysenck Self Esteem Questionnaire.</prim_outcome>
      <prim_outcome>The average score that the participants will obtain from the Perceived Stress Scale. Timepoint: Before and immediately after and 3 months after intervention. Method of measurement: Perceived Stress Scale.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-17</approval_date>
        <contact_name>Ethics committee of Birjand  University of Medical Science</contact_name>
        <contact_address>Birjand University of Medical Sciences - Ayatollah Ghaffari Street Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
