<?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>IRCT20211129053207N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-29</date_registration>
      <primary_sponsor>Universiti Putra Malaysia</primary_sponsor>
      <public_title>Establishing A Digital-Assisted Parenting Intervention (DaPI) in Promoting Children Mental Health</public_title>
      <acronym>DaPI (Digital-assisted Parenting Intervention)</acronym>
      <scientific_title>Establishing A Digital-Assisted Parenting Intervention (DaPI) in Promoting Children Mental Health</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60346</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: A project manager will be responsible to execute the randomization as to ensure blinding. Using simple random technique, each participant will be assigned with unique identification number generated by a random number generator using a 1:1 proportion. The participants will then be assigned to either the Digital-assisted Parenting Intervention (DaPI) or to the control group (i.e., waitlisted and will receive the intervention 12 weeks later), Blinding description: The outcome assessor and data analyser will be blinded because they are not involve with the allocation of groups or the online intervention. Data will be collected at pre-intervention (prior to group assignment), post-intervention (8-weeks) and 1 month follow up. 

.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mental health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group:  Parents in the intervention group will be given immediate access to the DaPI program. Parents will be emailed log in details and instructions to the program. They will be prompted to complete the program within 8 weeks (at which time post-intervention assessment will be conducted regardless of the number of sessions completed). DaPI will be covered in 8 sessions. The content of the sessions includes fostering positive relationship with child ; fostering child's optimal growth ; fostering effective family functioning; fostering parent child relationships; fostering parents' mental health; and fostering child's mental health. Parents will be guided with effective parenting skills through various techniques (i.e., written materials, videos, interactive activities, and feedback report on parenting behaviors). Each session will be delivered once a week and take roughly around 30 to 40 minutes depending on the time parents spend on the tasks in each session. Parents can access the program at their own convenience. Parents will also be able to access links to evidence-based parenting support and informational resources provided in each session. Throughout the 8-week intervention period, parents will be contacted via email if no logged-on activity is detected to the program. Intervention 2: Control group: Parents in the control (waitlist) group will receive no treatment during the trial but will be given access (12 weeks later) to the DaPI program once the trial ended.</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 If we decide to share IPD, it will be after the publication of the trial.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Nor Sheereen Zulkefly</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalan Universiti 1 Serdang, Seri Kembangan</address>
        <city>Serdang</city>
        <country1>Malaysia</country1>
        <zip>43400</zip>
        <telephone>+60 3-9769 2541</telephone>
        <email>sheereen@upm.edu.my</email>
        <affiliation>Universiti Putra Malaysia</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Nor Sheereen Zulkefly</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalan Universiti 1 Serdang, Seri Kembangan</address>
        <city>Serdang</city>
        <country1>Malaysia</country1>
        <zip>43400</zip>
        <telephone>+60 3-9769 2541</telephone>
        <email>sheereen@upm.edu.my</email>
        <affiliation>Universiti Putra Malaysia</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Parents who owned a smart phone, tablet or computer and have access to the Internet.
Parents who are willing to participate and provide information at scheduled follow-up points.
Parents who have good command and understanding of the Malay language.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parents who are digital illiterate.
Parents who have children with developmental delays.
Parents who are currently receiving professional assistance for their own and/or their child’s mental health problems.</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group:  Parents in the intervention group will be given immediate access to the DaPI program. Parents will be emailed log in details and instructions to the program. They will be prompted to complete the program within 8 weeks (at which time post-intervention assessment will be conducted regardless of the number of sessions completed). DaPI will be covered in 8 sessions. The content of the sessions includes fostering positive relationship with child ; fostering child's optimal growth ; fostering effective family functioning; fostering parent child relationships; fostering parents' mental health; and fostering child's mental health. Parents will be guided with effective parenting skills through various techniques (i.e., written materials, videos, interactive activities, and feedback report on parenting behaviors). Each session will be delivered once a week and take roughly around 30 to 40 minutes depending on the time parents spend on the tasks in each session. Parents can access the program at their own convenience. Parents will also be able to access links to evidence-based parenting support and informational resources provided in each session. Throughout the 8-week intervention period, parents will be contacted via email if no logged-on activity is detected to the program.</i_keyword>
      <i_keyword>Control group: Parents in the control (waitlist) group will receive no treatment during the trial but will be given access (12 weeks later) to the DaPI program once the trial ended.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Parenting styles. Timepoint: Before intervention, post-intervention (8 weeks), and 1 month follow-up. Method of measurement: Measured using the Parenting Scale by Arnold, O'Leary, Wolff, and Acker (1993).</prim_outcome>
      <prim_outcome>Parental self-efficacy. Timepoint: Before intervention, post-intervention (8 weeks), and 1 month follow-up. Method of measurement: Measured using the Child Adjustment and Parent Efficacy Scale by Morawska, Sanders, Haslam, Filus, &amp; Fletcher (2014).</prim_outcome>
      <prim_outcome>Parent mental health. Timepoint: Before intervention, post-intervention (8 weeks), and 1 month follow-up. Method of measurement: Measured using the Depression Anxiety Stress Scales-21 (Lovibond &amp; Lovibond, 1995).</prim_outcome>
      <prim_outcome>Parent-adolescent conflict. Timepoint: Before intervention, post-intervention (8 weeks), and 1 month follow-up. Method of measurement: Measured using the Network of Relationships Inventory (De Goede et al. 2009; Furman &amp; Buhrmester 1985).</prim_outcome>
      <prim_outcome>Interparental conflict. Timepoint: Before intervention, post-intervention (8 weeks), and 1 month follow-up. Method of measurement: Measured using Parent Problem Checklist (PPC; Dadds &amp; Powell, 1991).</prim_outcome>
      <prim_outcome>Family cohesion. Timepoint: Before intervention, post-intervention (8 weeks), and 1 month follow-up. Method of measurement: Measured using a scale developed by Tolan et al. (1997).</prim_outcome>
      <prim_outcome>Parental self-esteem. Timepoint: Before intervention, post-intervention (8 weeks), and 1 month follow-up. Method of measurement: Measured using the Rosenberg Self-esteem Scale.</prim_outcome>
      <prim_outcome>Children Mental Health. Timepoint: Before intervention, post-intervention (8 weeks), and 1 month follow-up. Method of measurement: Measured using the Child Adjustment and Parent Efficacy Scale (CAPES; Morawska, Sanders, Haslam, Filus, &amp; Fletcher, 2014).</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>High Education Ministry</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-02</approval_date>
        <contact_name>Ethic Committee for Research Involving Human Subjects Universiti Putra Malaysia (JKEUPM)</contact_name>
        <contact_address>Jalan Universiti 1 Serdang, Seri Kembangan Serdang Selangor Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
