<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03805828</url>
  </required_header>
  <id_info>
    <org_study_id>University Putra Malaysia</org_study_id>
    <nct_id>NCT03805828</nct_id>
  </id_info>
  <brief_title>Effectiveness of Educational Program on Parenting Stress and Coping Mechanism Among Parents of Children With Autism Spectrum Disorder in Amman, Jordan</brief_title>
  <official_title>The Effectiveness of an Educational Program on Parenting Stress and Coping Mechanism Among Parents of Children With Autism Spectrum Disorder in Amman, Jordan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Putra Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Putra Malaysia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Health and well being of children are inextricably linked to the physical, emotional and&#xD;
      psychological of their parents. Autism Spectrum Disorder is one of the neurological&#xD;
      developmental disorders characterized by moderate to severe impairments in social&#xD;
      interactions, language, and cognitive development, as well as included repetitive behaviors,&#xD;
      restricted interests, and emotional distress. Coping with a stressful situation is classified&#xD;
      as one of the most challenges in one's life. The overall aim of this study is to examine the&#xD;
      effectiveness of the educational program on parenting stress and coping mechanism among&#xD;
      parents of children with ASD in Amman, Jordan at baseline, post-test and at two months&#xD;
      follow-up assessment. Two hundred parents of children with Autism spectrum disorder will be&#xD;
      assigned to the intervention group (n = 100) and the control group (n = 100). Measures of&#xD;
      parent stress and coping mechanism using the parent stress index(PSI) and Brief COPE will&#xD;
      administer at pre-, post-treatment, and 2-months follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Health and well being of children are inextricably linked to the physical,&#xD;
      emotional and psychological of their parents. Maintaining the health and well-being of&#xD;
      parents is a precondition for the best optimal care of their children with Autism Spectrum&#xD;
      Disorder (ASD). The overall aim of the current study is to evaluate the effectiveness of an&#xD;
      educational program on parenting stress and coping mechanism among parents of children with&#xD;
      ASD in Jordan.&#xD;
&#xD;
      Methods: A cluster randomized controlled trial will be conducted in 4 private centers for the&#xD;
      treatment of Autistic Disorder in Amman, Jordan. Inclusion criteria: father or mother of a&#xD;
      child who diagnosed for the period of three years since the initial time of diagnosis, father&#xD;
      or mother who provides care and living together with the child, father or mother has the&#xD;
      ability to read and write Arabic, father or mother age above 20 years old,and center provides&#xD;
      caring just for ASD child with age 12 years and younger. Exclusion criteria: father or mother&#xD;
      whose child had other chronic or illnesses (e.g, type 1 diabetes, down syndrome, learning&#xD;
      disabilities, fetal alcohol syndrome), foreign father or mother of a child with ASD residents&#xD;
      in Amman, father or mother who previously participated in the intervention research (e.g,&#xD;
      Cognitive Behavior Therapy, Mindfulness-Based Intervention), father or mother of a child who&#xD;
      takes any pharmacologic management of ASD (e.g,Risperdal, Ritalin), father or mother with&#xD;
      more than one child diagnosed with ASD,and center doesn't include a suitable classroom for&#xD;
      implementing the intervention program. The educational intervention program will deliver to&#xD;
      the intervention group as a one-day event in four sessions. Whereas, the control group will&#xD;
      receive education about the communicable disease among childhood. With an estimated effect&#xD;
      design of 1.3, a cluster size of 4 and 20% non-completion, the trial will need to enroll 200&#xD;
      participants. The primary outcomes of the current study are parenting stress and coping&#xD;
      mechanism scores, which will be assessed using the Parent Stress Index-Short Form and Brief&#xD;
      COPE, respectively. parenting stress and coping mechanism scores will be assessed at&#xD;
      pre-intervention, post-intervention and follow-ups at week 8.&#xD;
&#xD;
      Results: The parenting stress and the coping mechanism will be compared between the&#xD;
      intervention and control groups using A 2×3 repeated measure ANOVA.&#xD;
&#xD;
      Conclusions: Hypothesize that primary outcomes will improve significantly after the&#xD;
      intervention compared to the control group. The finding from this study will determine the&#xD;
      effectiveness of the educational program on parenting stress and coping mechanism among&#xD;
      Jordanian parents of children with ASD. If proven to be effective, the educational program&#xD;
      can serve as a part of therapeutic plan support to reduce parenting stress and improve coping&#xD;
      mechanism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>parenting stress</measure>
    <time_frame>Mean change in scores of parenting stress from baseline to endpoint(two months follow-up) assessment</time_frame>
    <description>Self reported 36 statements on three subscales: parental distress (PD), parent-child dysfunctional interaction (P-CDI), and difficulty of the child (DC). Each subscale contains 12 items. The PSI-SF rated on a 5-point Likert scale, include 1 (strongly disagree) , 2 ( disagree ), 3 ( not sure ), 4 (agree) 5 (strongly agree), total scores range from 36 to 180. On the PSI-SF, stress levels considered normal with less than 90 scores , whereas , high-stress considered at or above the 90 scores</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coping mechanism</measure>
    <time_frame>Mean change in scores of coping mechanism from baseline to endpoint(two months follow-up) assessment</time_frame>
    <description>self-administered questionnaire twenty-eight items of the Brief COPE are grouped into fourteen subscales containing two items for each: acceptance, active coping, planning, behavioral disengagement, denial, substance use, humor, positive reframing, religious coping, self-blame, self-distraction, use of emotional support, use of instrumental support, and venting emotions . The items of subscale rated on a four-point Likert scale with a response for each item ranging from 1 ( I haven't been doing this at all ) to 4 (I have been doing this a lot)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Expermental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the intervention group, the educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control group, the educational about communicable disease among childhood deliver as a one-day event in four sessions: (1) introduction and background communicable disease of childhood,(2) communicable diseases of childhood (Chicken Pox, Diphtheria,and pertussis[a whooping cough]),(3) communicable diseases of childhood (Measles,Mumps,rubella[German Measles]and Poliomyelitis(,and (4) infection control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational program on parenting stress and coping mechanism</intervention_name>
    <description>The educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism. The contents of the educational program deliver through the use of PowerPoint slides, Whiteboard and marker, practical exercise, video clips followed by group discussion and provision a hard copy booklet containing all items which were supposed to discuss. As well as each session will approximately be taken one hour. Each group will consist of 10 participants.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Expermental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The participant's inclusion eligibility criteria:&#xD;
&#xD;
          -  Father or mother of a child who diagnosed for the period of three years since the&#xD;
             initial time of diagnosis&#xD;
&#xD;
          -  Father or mother who provides care and living together with the child&#xD;
&#xD;
          -  Father or mother has the ability to read and write Arabic, and (4) father or mother&#xD;
             age above 20 years old&#xD;
&#xD;
        The center's inclusion eligibility criteria:&#xD;
&#xD;
          -  Center provides caring only for ASD child with age 12 years and younger&#xD;
&#xD;
          -  Provide the following services: speech, language, occupational, physiotherapy,&#xD;
             educational, nutrition and medical services.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The participant's exclusion eligibility criteria&#xD;
&#xD;
          -  Father or mother whose child had other chronic or illnesses (e.g, type 1 diabetes,&#xD;
             down syndrome, learning disabilities, fetal alcohol syndrome)&#xD;
&#xD;
          -  Foreign father or mother of a child with ASD residents in Amman&#xD;
&#xD;
          -  Father or mother who previously participated in the intervention research (e.g,&#xD;
             Cognitive Behavior Therapy, Mindfulness-Based Intervention)&#xD;
&#xD;
          -  Father or mother of a child who takes any pharmacologic management of ASD&#xD;
             (e.g,Risperdal, Ritalin)&#xD;
&#xD;
          -  Father or mother with more than one child diagnosed with ASD&#xD;
&#xD;
        The center's exclusion eligibility criteria&#xD;
&#xD;
          -  Center doesn't include a suitable classroom for implementing the intervention program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Haytham Al-Oran, PhD student</last_name>
    <phone>+962775740645</phone>
    <email>hyttiemaloran@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lee Khuan, Dr.</last_name>
    <phone>603 - 8947 2438</phone>
    <email>leekhuan@upm.edu.my</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centers for the treatment of Autistic Disorder</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ministry of Social Development</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 12, 2019</last_update_submitted>
  <last_update_submitted_qc>January 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Putra Malaysia</investigator_affiliation>
    <investigator_full_name>Haytham Mohammad Al-Oran</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <keyword>Autism spectrum disorder</keyword>
  <keyword>parenting stress</keyword>
  <keyword>coping mechanism</keyword>
  <keyword>coping strategies</keyword>
  <keyword>education program</keyword>
  <keyword>educational intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Primary outcomes measures will be made available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available within 7 months</ipd_time_frame>
    <ipd_access_criteria>Date request will be reviewed by an external independent review panel. Requesters will be required to sign the data access agreement</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03805828
org study id: University Putra Malaysia
nct id: NCT03805828
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Health and well being of children are inextricably linked to the physical, emotional and
      psychological of their parents. Autism Spectrum Disorder is one of the neurological
      developmental disorders characterized by moderate to severe impairments in social
      interactions, language, and cognitive development, as well as included repetitive behaviors,
      restricted interests, and emotional distress. Coping with a stressful situation is classified
      as one of the most challenges in one's life. The overall aim of this study is to examine the
      effectiveness of the educational program on parenting stress and coping mechanism among
      parents of children with ASD in Amman, Jordan at baseline, post-test and at two months
      follow-up assessment. Two hundred parents of children with Autism spectrum disorder will be
      assigned to the intervention group (n = 100) and the control group (n = 100). Measures of
      parent stress and coping mechanism using the parent stress index(PSI) and Brief COPE will
      administer at pre-, post-treatment, and 2-months follow-up.
Background: Health and well being of children are inextricably linked to the physical,
      emotional and psychological of their parents. Maintaining the health and well-being of
      parents is a precondition for the best optimal care of their children with Autism Spectrum
      Disorder (ASD). The overall aim of the current study is to evaluate the effectiveness of an
      educational program on parenting stress and coping mechanism among parents of children with
      ASD in Jordan.

      Methods: A cluster randomized controlled trial will be conducted in 4 private centers for the
      treatment of Autistic Disorder in Amman, Jordan. Inclusion criteria: father or mother of a
      child who diagnosed for the period of three years since the initial time of diagnosis, father
      or mother who provides care and living together with the child, father or mother has the
      ability to read and write Arabic, father or mother age above 20 years old,and center provides
      caring just for ASD child with age 12 years and younger. Exclusion criteria: father or mother
      whose child had other chronic or illnesses (e.g, type 1 diabetes, down syndrome, learning
      disabilities, fetal alcohol syndrome), foreign father or mother of a child with ASD residents
      in Amman, father or mother who previously participated in the intervention research (e.g,
      Cognitive Behavior Therapy, Mindfulness-Based Intervention), father or mother of a child who
      takes any pharmacologic management of ASD (e.g,Risperdal, Ritalin), father or mother with
      more than one child diagnosed with ASD,and center doesn't include a suitable classroom for
      implementing the intervention program. The educational intervention program will deliver to
      the intervention group as a one-day event in four sessions. Whereas, the control group will
      receive education about the communicable disease among childhood. With an estimated effect
      design of 1.3, a cluster size of 4 and 20% non-completion, the trial will need to enroll 200
      participants. The primary outcomes of the current study are parenting stress and coping
      mechanism scores, which will be assessed using the Parent Stress Index-Short Form and Brief
      COPE, respectively. parenting stress and coping mechanism scores will be assessed at
      pre-intervention, post-intervention and follow-ups at week 8.

      Results: The parenting stress and the coping mechanism will be compared between the
      intervention and control groups using A 2×3 repeated measure ANOVA.

      Conclusions: Hypothesize that primary outcomes will improve significantly after the
      intervention compared to the control group. The finding from this study will determine the
      effectiveness of the educational program on parenting stress and coping mechanism among
      Jordanian parents of children with ASD. If proven to be effective, the educational program
      can serve as a part of therapeutic plan support to reduce parenting stress and improve coping
      mechanism.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: parenting stress
time frame: Mean change in scores of parenting stress from baseline to endpoint(two months follow-up) assessment
description: Self reported 36 statements on three subscales: parental distress (PD), parent-child dysfunctional interaction (P-CDI), and difficulty of the child (DC). Each subscale contains 12 items. The PSI-SF rated on a 5-point Likert scale, include 1 (strongly disagree) , 2 ( disagree ), 3 ( not sure ), 4 (agree) 5 (strongly agree), total scores range from 36 to 180. On the PSI-SF, stress levels considered normal with less than 90 scores , whereas , high-stress considered at or above the 90 scores
measure: coping mechanism
time frame: Mean change in scores of coping mechanism from baseline to endpoint(two months follow-up) assessment
description: self-administered questionnaire twenty-eight items of the Brief COPE are grouped into fourteen subscales containing two items for each: acceptance, active coping, planning, behavioral disengagement, denial, substance use, humor, positive reframing, religious coping, self-blame, self-distraction, use of emotional support, use of instrumental support, and venting emotions . The items of subscale rated on a four-point Likert scale with a response for each item ranging from 1 ( I haven't been doing this at all ) to 4 (I have been doing this a lot)
arm group label: Expermental
arm group type: Experimental
description: In the intervention group, the educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism.
arm group label: Control
arm group type: Active Comparator
description: In the control group, the educational about communicable disease among childhood deliver as a one-day event in four sessions: (1) introduction and background communicable disease of childhood,(2) communicable diseases of childhood (Chicken Pox, Diphtheria,and pertussis[a whooping cough]),(3) communicable diseases of childhood (Measles,Mumps,rubella[German Measles]and Poliomyelitis(,and (4) infection control.
intervention type: Other
intervention name: Educational program on parenting stress and coping mechanism
description: The educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism. The contents of the educational program deliver through the use of PowerPoint slides, Whiteboard and marker, practical exercise, video clips followed by group discussion and provision a hard copy booklet containing all items which were supposed to discuss. As well as each session will approximately be taken one hour. Each group will consist of 10 participants.
arm group label: Control
arm group label: Expermental
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Haytham Al-Oran, PhD student
phone: +962775740645
email: hyttiemaloran@yahoo.com
last name: Lee Khuan, Dr.
phone: 603 - 8947 2438
email: leekhuan@upm.edu.my
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
country: Jordan
responsible party type: Principal Investigator
investigator affiliation: Universiti Putra Malaysia
investigator full name: Haytham Mohammad Al-Oran
investigator title: principle investigator
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: Yes
ipd description: Primary outcomes measures will be made available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available within 7 months
ipd access criteria: Date request will be reviewed by an external independent review panel. Requesters will be required to sign the data access agreement