<?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>IRCT20210403050816N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-31</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effects of parent-child interaction training on  children's stuttering severity.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of Fluency Rules Program with and without parent-child interaction training in pre-school children who stutter</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55319</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: All eligible individuals will be divided equally into two groups of the Fluency Rules Program with and without parent-child interaction training using a simple block randomization method with a size of four blocks (including two individuals in each group). The online randomization service  Sealed Envelope Ltd will be used to generate the randomization allocation sequence. sequentially numbered, opaque, sealed envelopes (SNOSE) will also be used to conceal the allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stuttering.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A treatment session in the experimental group includes working with the child according to the instructions of the Fluency Rules Program (FRP) using parent-centered and interactive strategies. The parent-child interaction training package will be provided to the parents in the experimental group. At the beginning of each session, the therapist uses parent-centered strategies to train the parents about stuttering and controlling their concerns, then trains the interactive strategies for the parents. At the end of the session, the child will be treated according to the instructions of the FRP . Treatment in this group includes two 45-minute sessions per week for three months. Intervention 2: Control group: A treatment session in the control group includes working with the child according to the instructions of the Fluency Rules Program (FRP). Treatment in this group includes two 45-minute sessions per week for three months.</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 individual data of the research participants: All of the data could be shared after making the individuals unidentifiable.
Study execution protocol: The detailed study execution protocol could be shared in both the control and experimental groups.
Statistical analysis map: The statistical analysis plan of the present study could be published without any restrictions.
Informed consent form: The informed consent form which is designed for this study could be shared after making the individuals unidentifiable.

Clinical reports of this study: After the end of the study, the clinical reports which are related to this study could be published without any restrictions.


Analysis codes of this study: After the end of the study, the analysis codes of this study could be published without any restrictions.

Data coding systems: After the study, the data coding systems could be published without any restrictions.

When:
All documents related to this study are available 6 months after the publication of the results.

To whom:
Academic researchers and speech-language pathologists could request the documentation of this study.

Conditions:
There are no restrictions on using the data and analysis.
Any research or clinical use of the data is allowed.

Where to obtain:
first author:slp.barzegar@yahoo.com
Corresponding Author:adarouie@hotmail.com

How to obtain:
The applicant must send the application to the e-mail of the lead or the corresponding author. After reviewing the email and consulting with the research team, the files will be provided to the applicant within 10 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Barzegar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 14, 25rd Street, Resalat Avenue, Yazd Town</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8963116116</zip>
        <telephone>+98 35 3233 8251</telephone>
        <email>slp.barzegar@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Barzegar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 14, 25rd Street, Resalat Avenue, Yazd Town</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8963116116</zip>
        <telephone>+98 35 3233 8251</telephone>
        <email>slp.barzegar@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with stuttering in the age range of 3 to 7 years old.
Having stutter at a speech-language pathologist's discretion based on the Stuttering Severity Instrument-Third Edition (SSI-3)
Passing six months or more since the onset of stuttering.
The child is monolingual and Persian-speaking.
Not having any other treatment plan for stuttering while studying
Literate parent
The parent has enough time and necessary cooperation to read book and educational video files</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of any psychiatric medications as reported by parents and clients' record
The hearing impairment, speech-language, and neurological disorders</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A treatment session in the experimental group includes working with the child according to the instructions of the Fluency Rules Program (FRP) using parent-centered and interactive strategies. The parent-child interaction training package will be provided to the parents in the experimental group. At the beginning of each session, the therapist uses parent-centered strategies to train the parents about stuttering and controlling their concerns, then trains the interactive strategies for the parents. At the end of the session, the child will be treated according to the instructions of the FRP . Treatment in this group includes two 45-minute sessions per week for three months</i_keyword>
      <i_keyword>Control group: A treatment session in the control group includes working with the child according to the instructions of the Fluency Rules Program (FRP). Treatment in this group includes two 45-minute sessions per week for three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The child’s stuttering severity score is an initial outcome and it is determined by using the stuttering severity instrument test. Timepoint: The severity of children’s stuttering will be measured before the intervention and at the end of the study. Method of measurement: The stuttering measurement instrument of this study is the Stuttering Severity Instrument (SSI), which determines the severity of stuttering.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The impact of stuttering on your child. Timepoint: The impacts of stuttering on the child will be assessed at the beginning and end of the study. Method of measurement: It will be measured by using the Palin Parent Rating Scales.</sec_outcome>
      <sec_outcome>The impact of stuttering on parents. Timepoint: The impact of stuttering on parents will be assessed at the beginning and end of the study. Method of measurement: It will be measured by using the Palin Parent Rating Scales.</sec_outcome>
      <sec_outcome>Parents’ knowledge and confidence about managing stuttering. Timepoint: It will be assessed at the beginning and end of the study. Method of measurement: It will be measured by using the Palin Parent Rating Scales.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-14</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>No. 14, 25rd Street, Resalat Avenue, Yazd Town Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
