xml: <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/NCT05986305</url>
    </required_header>
    <id_info>
      <org_study_id>23-0739</org_study_id>
      <nct_id>NCT05986305</nct_id>
    </id_info>
    <brief_title>Improving the Health of Parents and Their Adolescent and Transition-age Youth With IDD</brief_title>
    <official_title>Improving the Health of Parents and Their Adolescent and Transition-age Youth With IDD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Patient-Centered Outcomes Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of North Carolina, Chapel Hill</source>
    <oversight_info>
      <has_dmc>No</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>
        A well-functioning system of care should provide a broad array of services that can support&#xD;
        families with a child with complex health care needs. Nonetheless, adolescents and transition&#xD;
        age youth with intellectual and developmental disabilities (IDD) experience rates of unmet&#xD;
        need for health care up to 6 times higher than others resulting in poor health and quality of&#xD;
        life for themselves and their families.&#xD;
  &#xD;
        The system of care approach has achieved positive impacts for children with IDD and their&#xD;
        families, but updates call for training to help parents develop advocacy skills on behalf of&#xD;
        their children. Prior research on diverse populations indicates that parent advocacy skills&#xD;
        are a promising target for increasing parent self-efficacy, which in turn is associated with&#xD;
        better parent and youth health outcomes. Parent advocacy skills can be increased through a&#xD;
        psychoeducational advocacy skills curriculum or through parent-directed peer-learning.&#xD;
        However, the comparative effectiveness of these two strategies for families raising youth&#xD;
        with IDD is not yet known.&#xD;
  &#xD;
        This study has two objectives. Fist, it will determine the comparative effectiveness of&#xD;
        GOACT, a tailored advocacy curriculum versus PEER parent-directed peer learning for&#xD;
        increasing parent activation for parents of youth with IDD. Second, it will determine the&#xD;
        comparative effectiveness of the two study arms for improving parent and youth health&#xD;
        outcomes while assessing whether parent activation serves as a mechanism that mediates their&#xD;
        effects on health outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2026</completion_date>
    <primary_completion_date type="Anticipated">March 2026</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>Difference in change in parent activation</measure>
      <time_frame>up to18 months after intervention</time_frame>
      <description>The Parent Patient Activation Measure (PPAM) will be used to capture parent activation on behalf of their child (mean score=70) at 6, 12 and 18 months after intervention. The PPAM is a parent self-report 13-item scale with 4-level Likert responses and scores ranging from 0 to 100.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Difference in change in youth social functioning- life satisfaction</measure>
      <time_frame>up to18 months after intervention</time_frame>
      <description>Youth social functioning will be assessed using the NIH Patient-Reported Outcomes Measurement Information System for children (Pediatric PROMIS) life satisfaction measure at 6, 12 and 18 months after intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Difference in change in parent depression</measure>
      <time_frame>up to 18 months after intervention</time_frame>
      <description>Parent depression will be measured with the 8-item Patient Health Questionnaire (PHQ-8) at 6, 12 and 18 months after intervention. The PHQ-8 is scored from 0 to 24.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference in change in parenting self-efficacy</measure>
      <time_frame>up to 18 months after intervention</time_frame>
      <description>The Tool to Measure Parenting Self-Efficacy (TOPSE) will be used to assess parent self-efficacy at 6, 12 and 18 months after intervention. The TOPSE short version consists of 36-items rated on an 11-point Likert scale, from 0 to 10 completely disagree to completely agree. Individual items are summed to create a total score, with higher scores indicating greater feelings of parenting self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in change in shared decision-making</measure>
      <time_frame>up to 18 months after intervention</time_frame>
      <description>Shared decision-making (SDM) will be assessed using a three-item scale from the National Survey of Children's Health (NSCH) at 6, 12 and 18 months after intervention. Respondents report on a 4-point Likert scale (never, sometimes, usually, or always) whether they feel that they 1) discuss with providers a range of treatment options; 2) are encouraged to raise concerns; 3) make treatment choices together. Mean scores range from 1 to 4 never to always.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in change in alliance</measure>
      <time_frame>up to 18 months after intervention</time_frame>
      <description>The adapted Parenting Alliance Inventory (PAI) will be used to measure parent-teacher alliance at 6, 12 and 18 months after intervention. The PAI was adapted to focus on parent-teacher alliance, and consists of 20 items scored on a 5-point Likert scale, producing a mean score between 1 and 5 never to always.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in change in goal attainment</measure>
      <time_frame>up to 18 months after intervention</time_frame>
      <description>Goal attainment will be assessed with the Psychometric equivalence tested goal attainment scale (GAS) at 6, 12 and 18 months after intervention. The GAS measurement system is based on a 5-point response scale ranging from -2 (worse expected outcome) to 2 (best expected outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in change in stress</measure>
      <time_frame>up to 18 months after intervention</time_frame>
      <description>Parent stress will be measured with the 17-item Parental Stress Scale (PSS) at 6, 12 and 18 months after intervention. Mean scores range from 1 to 5 with higher scores indicating higher stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in change in observed parent activation</measure>
      <time_frame>up to18 months after intervention</time_frame>
      <description>Observed parent activation will be assessed through audio-recorded parent-physician conversations at 6, 12 and 18 months after intervention. Evidence of parent activation will be examined: 1) providing context, 2) giving feedback, and 3) asking questions. Audio-recordings will be transcribed and a coding manual created.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in change in youth social functioning- meaning &amp; purpose</measure>
      <time_frame>up to 18 months after intervention</time_frame>
      <description>Youth social functioning will additionally be assessed using the NIH Patient-Reported Outcomes Measurement Information System for children (Pediatric PROMIS) meaning and purpose measure at 6, 12 and 18 months after intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in change in youth unmet need for care</measure>
      <time_frame>up to 18 months after intervention</time_frame>
      <description>Unmet need for care will be assessed using a three-item scale from the National Survey of Children's Health items at 6, 12 and 18 months after intervention. Respondents report 1) that they needed but did not receive care (yes/no), 2) types of care not received, and 3) reasons for not receiving care. Counts of reasons (0 to 6) are summed for each of 5 types of care.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in change in youth psychiatric crisis care use</measure>
      <time_frame>up to 18 months after intervention</time_frame>
      <description>Psychiatric crisis care use will be measured by number of emergency department visits at 6, 12 and 18 months after intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in change in number of inpatient psychiatric stays</measure>
      <time_frame>up to 18 months after intervention</time_frame>
      <description>Inpatient psychiatric stays will be measured by number of stays at 6, 12 and 18 months after intervention.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">404</enrollment>
    <condition>IDD</condition>
    <arm_group>
      <arm_group_label>GOACT</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>GOACT is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PEER</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PEER is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>GOACT</intervention_name>
      <description>GOACT sessions address becoming a parent who can 'Go Act,' caring for one's self as a parent, understanding and managing youth health needs, working with health providers as partners, and working with other service providers such as schools and vocational services. The intervention uses motivational interviewing, story-telling with self-disclosure, psycho-education introduced with a know-want to know-learned strategy, problem-solving, role play, and practice outside of class.</description>
      <arm_group_label>GOACT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>PEER</intervention_name>
      <description>During PEER sessions facilitators lay ground rules for respectful and confidential sharing and encourage group discussion. The group provides a format to make personal connections through shared identity. Participants may discuss strategies for individualized advocacy, so that they learn from the experiences of others.</description>
      <arm_group_label>PEER</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Parents&#xD;
  &#xD;
            -  Bringing their adolescent or young adult child (age 11-27), with diagnosed or&#xD;
               suspected intellectual or developmental disability, to one of the participating&#xD;
               clinics&#xD;
  &#xD;
            -  Able to attend group sessions&#xD;
  &#xD;
            -  Able to give informed consent&#xD;
  &#xD;
            -  Resident of North Carolina Youth&#xD;
  &#xD;
            -  Being between the ages of 11 and 27&#xD;
  &#xD;
            -  Having diagnosed or suspected intellectual or developmental disability&#xD;
  &#xD;
            -  Being present for a visit at one of the study clinics&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Parents&#xD;
  &#xD;
            -  Having evidence of emergency mental health needs&#xD;
  &#xD;
            -  Not willing to be recorded&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>27 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kathleen C Thomas, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of North Carolina, Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kathleen C Thomas, PhD</last_name>
      <phone>9199663387</phone>
      <email>kathleen_thomas@unc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Family Medicine at the Mountain Area Health Education Center</name>
        <address>
          <city>Asheville</city>
          <state>North Carolina</state>
          <zip>28803</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rebecca Putnam, MD</last_name>
        <phone>828-257-4400</phone>
        <email>rebecca.putnam@mahec.net</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Carolina Institute for Developmental Disabilities</name>
        <address>
          <city>Carrboro</city>
          <state>North Carolina</state>
          <zip>27510</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Robert Christian, MD</last_name>
        <phone>919-966-5171</phone>
        <email>rob.christian@cidd.unc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UNC Adult Psychiatry Clinic</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27514</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>James Bedford, MD</last_name>
        <phone>984-974-5217</phone>
        <email>james_bedford@med.unc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).</ipd_description>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Beginning 9 and continuing for 36 months following publication</ipd_time_frame>
      <ipd_access_criteria>Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986305
  org study id: 23-0739
  nct id: NCT05986305
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A well-functioning system of care should provide a broad array of services that can support
        families with a child with complex health care needs. Nonetheless, adolescents and transition
        age youth with intellectual and developmental disabilities (IDD) experience rates of unmet
        need for health care up to 6 times higher than others resulting in poor health and quality of
        life for themselves and their families.
  
        The system of care approach has achieved positive impacts for children with IDD and their
        families, but updates call for training to help parents develop advocacy skills on behalf of
        their children. Prior research on diverse populations indicates that parent advocacy skills
        are a promising target for increasing parent self-efficacy, which in turn is associated with
        better parent and youth health outcomes. Parent advocacy skills can be increased through a
        psychoeducational advocacy skills curriculum or through parent-directed peer-learning.
        However, the comparative effectiveness of these two strategies for families raising youth
        with IDD is not yet known.
  
        This study has two objectives. Fist, it will determine the comparative effectiveness of
        GOACT, a tailored advocacy curriculum versus PEER parent-directed peer learning for
        increasing parent activation for parents of youth with IDD. Second, it will determine the
        comparative effectiveness of the two study arms for improving parent and youth health
        outcomes while assessing whether parent activation serves as a mechanism that mediates their
        effects on health outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Difference in change in parent activation
  time frame: up to18 months after intervention
  description: The Parent Patient Activation Measure (PPAM) will be used to capture parent activation on behalf of their child (mean score=70) at 6, 12 and 18 months after intervention. The PPAM is a parent self-report 13-item scale with 4-level Likert responses and scores ranging from 0 to 100.
  measure: Difference in change in youth social functioning- life satisfaction
  time frame: up to18 months after intervention
  description: Youth social functioning will be assessed using the NIH Patient-Reported Outcomes Measurement Information System for children (Pediatric PROMIS) life satisfaction measure at 6, 12 and 18 months after intervention.
  measure: Difference in change in parent depression
  time frame: up to 18 months after intervention
  description: Parent depression will be measured with the 8-item Patient Health Questionnaire (PHQ-8) at 6, 12 and 18 months after intervention. The PHQ-8 is scored from 0 to 24.
  measure: Difference in change in parenting self-efficacy
  time frame: up to 18 months after intervention
  description: The Tool to Measure Parenting Self-Efficacy (TOPSE) will be used to assess parent self-efficacy at 6, 12 and 18 months after intervention. The TOPSE short version consists of 36-items rated on an 11-point Likert scale, from 0 to 10 completely disagree to completely agree. Individual items are summed to create a total score, with higher scores indicating greater feelings of parenting self-efficacy.
  measure: Difference in change in shared decision-making
  time frame: up to 18 months after intervention
  description: Shared decision-making (SDM) will be assessed using a three-item scale from the National Survey of Children's Health (NSCH) at 6, 12 and 18 months after intervention. Respondents report on a 4-point Likert scale (never, sometimes, usually, or always) whether they feel that they 1) discuss with providers a range of treatment options; 2) are encouraged to raise concerns; 3) make treatment choices together. Mean scores range from 1 to 4 never to always.
  measure: Difference in change in alliance
  time frame: up to 18 months after intervention
  description: The adapted Parenting Alliance Inventory (PAI) will be used to measure parent-teacher alliance at 6, 12 and 18 months after intervention. The PAI was adapted to focus on parent-teacher alliance, and consists of 20 items scored on a 5-point Likert scale, producing a mean score between 1 and 5 never to always.
  measure: Difference in change in goal attainment
  time frame: up to 18 months after intervention
  description: Goal attainment will be assessed with the Psychometric equivalence tested goal attainment scale (GAS) at 6, 12 and 18 months after intervention. The GAS measurement system is based on a 5-point response scale ranging from -2 (worse expected outcome) to 2 (best expected outcome).
  measure: Difference in change in stress
  time frame: up to 18 months after intervention
  description: Parent stress will be measured with the 17-item Parental Stress Scale (PSS) at 6, 12 and 18 months after intervention. Mean scores range from 1 to 5 with higher scores indicating higher stress.
  measure: Difference in change in observed parent activation
  time frame: up to18 months after intervention
  description: Observed parent activation will be assessed through audio-recorded parent-physician conversations at 6, 12 and 18 months after intervention. Evidence of parent activation will be examined: 1) providing context, 2) giving feedback, and 3) asking questions. Audio-recordings will be transcribed and a coding manual created.
  measure: Difference in change in youth social functioning- meaning & purpose
  time frame: up to 18 months after intervention
  description: Youth social functioning will additionally be assessed using the NIH Patient-Reported Outcomes Measurement Information System for children (Pediatric PROMIS) meaning and purpose measure at 6, 12 and 18 months after intervention.
  measure: Difference in change in youth unmet need for care
  time frame: up to 18 months after intervention
  description: Unmet need for care will be assessed using a three-item scale from the National Survey of Children's Health items at 6, 12 and 18 months after intervention. Respondents report 1) that they needed but did not receive care (yes/no), 2) types of care not received, and 3) reasons for not receiving care. Counts of reasons (0 to 6) are summed for each of 5 types of care.
  measure: Difference in change in youth psychiatric crisis care use
  time frame: up to 18 months after intervention
  description: Psychiatric crisis care use will be measured by number of emergency department visits at 6, 12 and 18 months after intervention.
  measure: Difference in change in number of inpatient psychiatric stays
  time frame: up to 18 months after intervention
  description: Inpatient psychiatric stays will be measured by number of stays at 6, 12 and 18 months after intervention.
  arm group label: GOACT
  arm group type: Active Comparator
  description: GOACT is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period.
  arm group label: PEER
  arm group type: Active Comparator
  description: PEER is structured as a small group intervention for parents, consisting of four 60-minute sessions occurring over a 4-week period.
  intervention type: Behavioral
  intervention name: GOACT
  description: GOACT sessions address becoming a parent who can 'Go Act,' caring for one's self as a parent, understanding and managing youth health needs, working with health providers as partners, and working with other service providers such as schools and vocational services. The intervention uses motivational interviewing, story-telling with self-disclosure, psycho-education introduced with a know-want to know-learned strategy, problem-solving, role play, and practice outside of class.
  arm group label: GOACT
  intervention type: Behavioral
  intervention name: PEER
  description: During PEER sessions facilitators lay ground rules for respectful and confidential sharing and encourage group discussion. The group provides a format to make personal connections through shared identity. Participants may discuss strategies for individualized advocacy, so that they learn from the experiences of others.
  arm group label: PEER
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 27 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kathleen C Thomas, PhD
  role: Principal Investigator
  affiliation: University of North Carolina, Chapel Hill
  last name: Kathleen C Thomas, PhD
  phone: 9199663387
  email: kathleen_thomas@unc.edu
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Beginning 9 and continuing for 36 months following publication
  ipd access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.