<?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>IRCT20250702066336N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-17</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of child-parent relationship play therapy (CPRT) in the quality of relationship and parenting stress in parents of children with visual</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of child-parent relationship play therapy (CPRT) in the quality of relationship and parenting stress in parents of children with visual</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85783</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation of participants to the experimental and control groups will be carried out using the block randomization method. For this purpose, blocks of four will be applied. Six blocks will be created from all possible permutations of these four combinations. The list of these permutations will be provided below. At each step, one of these blocks will be randomly selected, and allocation will be made according to the order specified in that block. This procedure will be performed using statistical software by a statistical consultant; therefore, the interventionist will remain unaware of the allocation of the next participant, Blinding description: Given that the participant is not aware of whether they have been assigned to the control group or the experimental group, and that the intervention they receive—either the main intervention (Parent–Child Relationship–Based Play Therapy) or the neutral intervention (psychoeducational training on developmental needs)—the intervention is considered participant-blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>quality of relationship -  parenting stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The parents of children with visual impairments who meet the inclusion and exclusion criteria of the target population and are selected through convenience sampling will be assigned to the experimental group using block randomization for treatment. Intervention 2: Control group: The parents of children with visual impairments who meet the inclusion and exclusion criteria mentioned above and are selected through convenience sampling will be assigned to the control group using block randomization. For the members of this group as well, group psychoeducational sessions will be held focusing on the developmental needs of children.</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 obtained from the pre-test, post-test, and follow-up assessments can be shared after de-identifying the participants.

When:
The access period will begin one year after the publication of the results.

To whom:
It will be available to students and researchers affiliated with academic and scientific institutions.

Conditions:
Researchers are permitted to use the data provided that it is utilized for scientific and research purposes.

Where to obtain:
mahlamohamaddost@gmail.com

How to obtain:
Obtaining an introduction letter from the university or institution with which the researcher is affiliated.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Salek Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 130, Montazeri Ave., Ashtab Alley., Tabriz City</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5163916353</zip>
        <telephone>+98 41 3335 0367</telephone>
        <email>salekebrahimi@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Salek Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 130, Montazeri Ave., Ashtab Alley., Tabriz City</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5163916353</zip>
        <telephone>+98 41 3335 0367</telephone>
        <email>salekebrahimi@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Vision problems in the child
Age 6 to 9 years in children
Full parental consent to participate in the research
Parents must have at least a 12th grade education.
Having high scores on parenting stress and relationship quality questionnaires before intervention</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>9 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Regrets about participating in the study
Missing more than two therapy sessions
Failure to complete questionnaires by parents
Simultaneous participation in other psychotherapy sessions
The need to take psychiatric medications during intervention sessions
Drug therapy from six months before the study to its start
Receiving other psychotherapy services simultaneously by the parent or child
Presence of vision problems in parents
Presence of psychiatric problems including attention deficit hyperactivity disorder, mental retardation, and autism spectrum disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: The parents of children with visual impairments who meet the inclusion and exclusion criteria of the target population and are selected through convenience sampling will be assigned to the experimental group using block randomization for treatment.</i_keyword>
      <i_keyword>Control group: The parents of children with visual impairments who meet the inclusion and exclusion criteria mentioned above and are selected through convenience sampling will be assigned to the control group using block randomization. For the members of this group as well, group psychoeducational sessions will be held focusing on the developmental needs of children.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Relationship quality score in the Pianta Parent-Child Questionnaire. Timepoint: Measurement of relationship quality at pre-test, post-test (after the intervention), and follow-up stages for both groups. Method of measurement: Pianta Parent-Child Questionnaire.</prim_outcome>
      <prim_outcome>Parental stress score in the Abidin Short Form Parenting Stress Index. Timepoint: Measurement of parental stress at pre-test, post-test (after the intervention), and follow-up stages for both groups. Method of measurement: Abidin Short Form Parenting Stress Index.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-06</approval_date>
        <contact_name>Research Ethics Committees of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht street, Central Building No. 2, 3rd Floor, office of the Vice Chancellor for Research and Technology. Tabriz University of Medical sciences Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
