<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/NCT02236650</url>
  </required_header>
  <id_info>
    <org_study_id>SLUBM_24272</org_study_id>
    <nct_id>NCT02236650</nct_id>
  </id_info>
  <brief_title>Primary Care Stepping Stones Triple P for Children With Autism</brief_title>
  <official_title>A Pilot Study of Primary Care Stepping Stones Triple P for Children With Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of Primary Care Stepping Stones&#xD;
      Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve&#xD;
      the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years),&#xD;
      increase parental resilience and decrease parental stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research literature exists on best practices for screening and diagnosing children with&#xD;
      Autism. However, less is known about how to intervene with the child's parent. Across&#xD;
      studies, relative to parents of children without disabilities, parents of children with&#xD;
      Autism have reported higher levels of stress and lower levels of parenting competence. Such&#xD;
      stress places children at risk for adverse developmental outcomes&#xD;
&#xD;
      The proposed study aims to determine the effectiveness of Primary Care Stepping Stones Triple&#xD;
      P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve the&#xD;
      behavioral functioning of children newly diagnosed with Autism (aged 2-12 years), increase&#xD;
      parental resilience and decrease parental stress.&#xD;
&#xD;
      The specific hypotheses include:&#xD;
&#xD;
        1. Children whose parents receive PC-SS Triple P will demonstrate significantly greater&#xD;
           improvements in their behavioral functioning than children of parents receiving&#xD;
           Wait-list Control (WLC) at service closure.&#xD;
&#xD;
        2. At service closure, parents receiving the PC-SS Triple P intervention will be more&#xD;
           resilient and demonstrate lower levels of stress than parents in the Wait-List Control&#xD;
           (WLC) condition.&#xD;
&#xD;
        3. Parenting resilience and levels of parental stress will be positively associated with&#xD;
           improvements in child behavior.&#xD;
&#xD;
      Seventy-six parents of children newly diagnosed with Autism will be randomized into one of&#xD;
      two conditions: a) PC-SS Triple P (N=38) or b) Wait List Control (WLC; N=38). Study data will&#xD;
      be collected with the assistance of a data collector appropriately trained in human subject&#xD;
      rights protections.&#xD;
&#xD;
      It is anticipated that the present project will assist in the development and use of&#xD;
      evidence-based practices for working with parents of children newly diagnosed with Autism&#xD;
      within pediatric settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Eyberg Child Behavior Inventory Score at 4 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Measure conduct problem behavior in children between the ages of 2 and 16 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Connor-Davidson Resilience Scale Score at 4 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>General scale of resilience in adult populations with a bias towards coping with stress and adversity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Parent Stress Index - Short Form Score at 4 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Sources and different types of stress that every parent can experience. Provides information in 4 specific domains of parenting stress:&#xD;
Parental Distress,&#xD;
Parent-Child Dysfunctional Interaction,&#xD;
Difficult Child, and&#xD;
Total Stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Family Assessment Device score at 4 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Assesses family functioning on six different dimensions:&#xD;
Problem Solving (ability to resolve problems),&#xD;
Communication (exchange of clear and direct verbal information),&#xD;
Roles (division of responsibility for completing family tasks),&#xD;
Affective Responsiveness (ability to respond with appropriate emotion),&#xD;
Affective Involvement (degree to which family members are involved and interested in one another), and&#xD;
Behavior Control (manner used to express and maintain standards of behavior).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Aberrant Behavior Checklist Score at 4 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Assesses behavior problems in individuals with developmental disabilities across 5 domains:&#xD;
Irritability and Agitation (15 items)&#xD;
Lethargy and Social Withdrawal (16 items)&#xD;
Stereotypic Behavior (7 items)&#xD;
Hyperactivity and Noncompliance (16 items) and&#xD;
Inappropriate Speech (4 items).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in The Parenting Scale Score at 4 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Measures dysfunctional discipline styles in parents by asking about the probability with which the parent uses particular discipline strategies. It yields four scores:&#xD;
Total score,&#xD;
Laxness (permissive, inconsistent discipline);&#xD;
Over-reactivity (harsh, emotional, authoritarian discipline and irritability); and&#xD;
Verbosity/Hostility (use of verbal or physical force).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Parenting Sense of Competence Scale Score at 4 weeks</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Measures parents' sense of confidence and satisfaction with their parenting and their self-efficacy in the parenting role.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Primary Care Stepping Stones Triple P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Primary Care Stepping Stones Triple P program (PC-SS Triple P) - a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Control (WLC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wait List Control - Participants who will have access to treatment as usual services during the 4 weeks between baseline and 4 week assessment time points and then will have the opportunity to receive PC-SS Triple P.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Primary Care Stepping Stones Triple P (PC-SS Triple P)</intervention_name>
    <description>PC-SS Triple P is a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.</description>
    <arm_group_label>Primary Care Stepping Stones Triple P</arm_group_label>
    <other_name>Postive Parenting Program</other_name>
    <other_name>Triple P</other_name>
    <other_name>Stepping Stones Triple P</other_name>
    <other_name>Stepping Stones Positive Parenting Program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Treatment as Usual for 4 weeks</description>
    <arm_group_label>Wait List Control (WLC)</arm_group_label>
    <other_name>Service as Usual</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Parent inclusion criteria:&#xD;
&#xD;
          -  being at least 18 years of age&#xD;
&#xD;
        Index child inclusion criteria:&#xD;
&#xD;
          -  receives a Diagnostic and Statistical Manual V (DSM-V) diagnosis of Autism with mild&#xD;
             or moderate severity within 12 months of study onset.&#xD;
&#xD;
          -  age is &gt; or equal to 24 months (2 years, 0 months) and &lt; or equal to 155 months old&#xD;
             (12 years, 11 months).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Parent exclusion criteria:&#xD;
&#xD;
          -  inability to provide informed consent.&#xD;
&#xD;
          -  being non-English speaking.&#xD;
&#xD;
        Index child exclusion criteria:&#xD;
&#xD;
          -  being a ward of the State of Missouri.&#xD;
&#xD;
          -  being a sibling of another study participant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Debra H. Zand, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Louis University School of Medicine, Department of Pediatrics, Division of Developmental Pediatrics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis University, Knights of Columbus Developmental Center</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://sites.google.com/a/slu.edu/debra-h-zand-ph-d/parent-child-intervention-research-team-p-chirt</url>
    <description>Family Research Collaborative - Autism &amp; Parenting Resilience</description>
  </link>
  <reference>
    <citation>Turner K, Markie-Dadds C, Sanders M. Practitioner's manual for primary care tripleP. Brisbane, QLD, Australia: Triple P International Pty. Ltd.; 2010.</citation>
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  <reference>
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  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>December 16, 2015</last_update_submitted>
  <last_update_submitted_qc>December 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Debra H. Zand, Ph.D.</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Parental Resilience</keyword>
  <keyword>Parental Stress</keyword>
  <keyword>Family Adaptation</keyword>
  <keyword>Autistic Disorder</keyword>
  <keyword>Behavior</keyword>
  <keyword>Child Behavior</keyword>
  <keyword>Child Development Disorders</keyword>
  <keyword>Pervasive Developmental Disabilities</keyword>
  <keyword>Caregivers</keyword>
  <keyword>Parents</keyword>
  <keyword>Parenting</keyword>
  <keyword>Primary Health Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT02236650
org study id: SLUBM_24272
nct id: NCT02236650
lead sponsor: 
has dmc: No
The purpose of this study is to determine the effectiveness of Primary Care Stepping Stones
      Triple P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve
      the behavioral functioning of children newly diagnosed with Autism (aged 2-12 years),
      increase parental resilience and decrease parental stress.
Research literature exists on best practices for screening and diagnosing children with
      Autism. However, less is known about how to intervene with the child's parent. Across
      studies, relative to parents of children without disabilities, parents of children with
      Autism have reported higher levels of stress and lower levels of parenting competence. Such
      stress places children at risk for adverse developmental outcomes

      The proposed study aims to determine the effectiveness of Primary Care Stepping Stones Triple
      P (PC-SS Triple P), an empirically supported parent mediated intervention, to improve the
      behavioral functioning of children newly diagnosed with Autism (aged 2-12 years), increase
      parental resilience and decrease parental stress.

      The specific hypotheses include:

        1. Children whose parents receive PC-SS Triple P will demonstrate significantly greater
           improvements in their behavioral functioning than children of parents receiving
           Wait-list Control (WLC) at service closure.

        2. At service closure, parents receiving the PC-SS Triple P intervention will be more
           resilient and demonstrate lower levels of stress than parents in the Wait-List Control
           (WLC) condition.

        3. Parenting resilience and levels of parental stress will be positively associated with
           improvements in child behavior.

      Seventy-six parents of children newly diagnosed with Autism will be randomized into one of
      two conditions: a) PC-SS Triple P (N=38) or b) Wait List Control (WLC; N=38). Study data will
      be collected with the assistance of a data collector appropriately trained in human subject
      rights protections.

      It is anticipated that the present project will assist in the development and use of
      evidence-based practices for working with parents of children newly diagnosed with Autism
      within pediatric settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline in Eyberg Child Behavior Inventory Score at 4 weeks
time frame: Baseline and 4 weeks
description: Measure conduct problem behavior in children between the ages of 2 and 16 years.
measure: Change from Baseline in Connor-Davidson Resilience Scale Score at 4 weeks
time frame: Baseline and 4 weeks
description: General scale of resilience in adult populations with a bias towards coping with stress and adversity.
measure: Change from Baseline in Parent Stress Index - Short Form Score at 4 weeks
time frame: Baseline and 4 weeks
description: Sources and different types of stress that every parent can experience. Provides information in 4 specific domains of parenting stress:
Parental Distress,
Parent-Child Dysfunctional Interaction,
Difficult Child, and
Total Stress.
measure: Change from Baseline in Family Assessment Device score at 4 weeks
time frame: Baseline and 4 weeks
description: Assesses family functioning on six different dimensions:
Problem Solving (ability to resolve problems),
Communication (exchange of clear and direct verbal information),
Roles (division of responsibility for completing family tasks),
Affective Responsiveness (ability to respond with appropriate emotion),
Affective Involvement (degree to which family members are involved and interested in one another), and
Behavior Control (manner used to express and maintain standards of behavior).
measure: Change from Baseline in Aberrant Behavior Checklist Score at 4 weeks
time frame: Baseline and 4 weeks
description: Assesses behavior problems in individuals with developmental disabilities across 5 domains:
Irritability and Agitation (15 items)
Lethargy and Social Withdrawal (16 items)
Stereotypic Behavior (7 items)
Hyperactivity and Noncompliance (16 items) and
Inappropriate Speech (4 items).
measure: Change from Baseline in The Parenting Scale Score at 4 weeks
time frame: Baseline and 4 weeks
description: Measures dysfunctional discipline styles in parents by asking about the probability with which the parent uses particular discipline strategies. It yields four scores:
Total score,
Laxness (permissive, inconsistent discipline);
Over-reactivity (harsh, emotional, authoritarian discipline and irritability); and
Verbosity/Hostility (use of verbal or physical force).
measure: Change from Baseline in the Parenting Sense of Competence Scale Score at 4 weeks
time frame: Baseline and 4 weeks
description: Measures parents' sense of confidence and satisfaction with their parenting and their self-efficacy in the parenting role.
arm group label: Primary Care Stepping Stones Triple P
arm group type: Experimental
description: Primary Care Stepping Stones Triple P program (PC-SS Triple P) - a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.
arm group label: Wait List Control (WLC)
arm group type: Active Comparator
description: Wait List Control - Participants who will have access to treatment as usual services during the 4 weeks between baseline and 4 week assessment time points and then will have the opportunity to receive PC-SS Triple P.
intervention type: Behavioral
intervention name: Primary Care Stepping Stones Triple P (PC-SS Triple P)
description: PC-SS Triple P is a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.
arm group label: Primary Care Stepping Stones Triple P
other name: Postive Parenting Program
other name: Triple P
other name: Stepping Stones Triple P
other name: Stepping Stones Positive Parenting Program
intervention type: Other
intervention name: Treatment as Usual
description: Treatment as Usual for 4 weeks
arm group label: Wait List Control (WLC)
other name: Service as Usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Debra H. Zand, PhD
role: Principal Investigator
affiliation: Saint Louis University School of Medicine, Department of Pediatrics, Division of Developmental Pediatrics
facility: 
country: United States
url: https://sites.google.com/a/slu.edu/debra-h-zand-ph-d/parent-child-intervention-research-team-p-chirt
description: Family Research Collaborative - Autism & Parenting Resilience
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responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Debra H. Zand, Ph.D.
investigator title: Associate Professor of Pediatrics
mesh term: Autistic Disorder