<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/NCT02199704</url>
  </required_header>
  <id_info>
    <org_study_id>14/NW/0126</org_study_id>
    <nct_id>NCT02199704</nct_id>
  </id_info>
  <brief_title>Self Directed Positive Parenting Program (Triple P) for Psychosis: A Clinical Case Series</brief_title>
  <official_title>Self Directed Positive Parenting Program (Triple P) for Psychosis: A Clinical Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lancashire Care NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manchester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the case series study is to explore if a self directed version of the Positive&#xD;
      Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with&#xD;
      psychosis who are parents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Psychotic Symptom Rating Scales (PSYRATS)</measure>
    <time_frame>Initial Ax, Multiple Baseline Ax, Final Baseline Ax, Up to 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks.</time_frame>
    <description>Ax from 0 - 16 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting and Family Adjustment Scale (PAFAS)</measure>
    <time_frame>Initial Ax, Multiple Baselines, Final Baseline, Support Sessions, End Ax, Follow Up. Ax from 0 - 16 weeks.</time_frame>
    <description>Ax from 0 - 16 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eyberg Child Behaviour Inventory (ECBI)</measure>
    <time_frame>Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.</time_frame>
    <description>Ax from 0 - 16 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Task Checklist (PTC)</measure>
    <time_frame>Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.</time_frame>
    <description>Ax from 0 - 16 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Anxiety and Stress Scale (DASS-21)</measure>
    <time_frame>Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.</time_frame>
    <description>Ax from 0 - 16 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work and Social Adjustment Scale (WSAS)</measure>
    <time_frame>Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.</time_frame>
    <description>Ax from 0 - 16 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Warwick-Edinburgh Mental Well-being Scale (WEMWBS)</measure>
    <time_frame>Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.</time_frame>
    <description>Ax from 0 - 16 weeks.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Spectrum</condition>
  <condition>Disorders</condition>
  <arm_group>
    <arm_group_label>No control or comparison arm.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This case series study has no control or comparison arm. There is only one arm being evaluated (the self directed parenting intervention).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self Directed Positive Parenting Program</intervention_name>
    <description>Individuals with psychosis who are parents will receive a copy of the &quot;Every Parent's Self Help Workbook&quot; (Markie-Dadds, Sanders &amp; Turner, 1999) and up to ten sessions of support. This is a case series study.</description>
    <arm_group_label>No control or comparison arm.</arm_group_label>
    <other_name>&quot;Every Parent's Self Help Workbook&quot;</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Parents/caregivers (mothers or fathers) with a Schizophrenia-spectrum diagnosis who&#xD;
             are:&#xD;
&#xD;
             2. Aged 18 years or more&#xD;
&#xD;
             3. Have at least one child aged 3-10 years old&#xD;
&#xD;
             4. Have a least 10 hours contact time per week with the child.&#xD;
&#xD;
             5. Identify difficulties in parenting during assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Parents/caregivers and family members who do not have good working knowledge of&#xD;
             English. They should have enough practical experience to be able to adequately use the&#xD;
             English language to understand and respond to questions, to read and complete&#xD;
             questionnaires&#xD;
&#xD;
             2. Families who do not have at least one adult who has basic literacy skills&#xD;
&#xD;
             3. Families where there is known intention for their children to be taken into care or&#xD;
             where the parent(s) have no regular contact with the index child&#xD;
&#xD;
             4. Parents with a clinical schizophrenia-spectrum diagnosis who have recently been&#xD;
             discharged from acute in-patient care for their condition and have less than four&#xD;
             weeks of stabilisation of psychotic experiences (operationally defined as no&#xD;
             significant change to management or severity of symptoms in a four-week period since&#xD;
             discharge as assessed from case notes). This is because if a potential parent with&#xD;
             schizophrenia had recently required an inpatient stay, it is important to give them&#xD;
             sufficient time to readjust to living in the community and ensure sufficient time is&#xD;
             provided for symptom stabilisation before taking part&#xD;
&#xD;
             5. Families seeking support from services regarding child management issues&#xD;
&#xD;
             6. Families actively involved in another current cognitive behavioural therapy based&#xD;
             intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prof Rachel Calam, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Manchester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Manchester</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 31, 2016</last_update_submitted>
  <last_update_submitted_qc>July 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Dr Chris Taylor</investigator_full_name>
    <investigator_title>Clinical Psychologist</investigator_title>
  </responsible_party>
  <keyword>Parenting</keyword>
  <keyword>Psychosis</keyword>
  <keyword>Schizophrenia</keyword>
  <keyword>Delusions</keyword>
  <keyword>Hallucinations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</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/NCT02199704
org study id: 14/NW/0126
nct id: NCT02199704
lead sponsor: 
collaborator: 
has dmc: No
The aim of the case series study is to explore if a self directed version of the Positive
      Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with
      psychosis who are parents.
As above.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: The Psychotic Symptom Rating Scales (PSYRATS)
time frame: Initial Ax, Multiple Baseline Ax, Final Baseline Ax, Up to 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks.
description: Ax from 0 - 16 weeks.
measure: Parenting and Family Adjustment Scale (PAFAS)
time frame: Initial Ax, Multiple Baselines, Final Baseline, Support Sessions, End Ax, Follow Up. Ax from 0 - 16 weeks.
description: Ax from 0 - 16 weeks.
measure: Eyberg Child Behaviour Inventory (ECBI)
time frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
description: Ax from 0 - 16 weeks.
measure: Parenting Task Checklist (PTC)
time frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
description: Ax from 0 - 16 weeks.
measure: Depression Anxiety and Stress Scale (DASS-21)
time frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
description: Ax from 0 - 16 weeks.
measure: Work and Social Adjustment Scale (WSAS)
time frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
description: Ax from 0 - 16 weeks.
measure: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
time frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
description: Ax from 0 - 16 weeks.
arm group label: No control or comparison arm.
arm group type: Other
description: This case series study has no control or comparison arm. There is only one arm being evaluated (the self directed parenting intervention).
intervention type: Other
intervention name: Self Directed Positive Parenting Program
description: Individuals with psychosis who are parents will receive a copy of the "Every Parent's Self Help Workbook" (Markie-Dadds, Sanders & Turner, 1999) and up to ten sessions of support. This is a case series study.
arm group label: No control or comparison arm.
other name: "Every Parent's Self Help Workbook"
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Prof Rachel Calam, PhD
role: Study Chair
affiliation: University of Manchester
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Dr Chris Taylor
investigator title: Clinical Psychologist
mesh term: Schizophrenia
mesh term: Psychotic Disorders
mesh term: Mental Disorders