<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/NCT03301831</url>
  </required_header>
  <id_info>
    <org_study_id>08-10-30</org_study_id>
    <secondary_id>1R15NR017302-01</secondary_id>
    <nct_id>NCT03301831</nct_id>
  </id_info>
  <brief_title>Resourcefulness Intervention With Parents of Technology-Dependent Children</brief_title>
  <official_title>Intervention Pilot With Parents of Technology-Dependent Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</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>
      Technology-dependent children, those who live at home but rely on medical equipment such as&#xD;
      mechanical ventilation or feeding tubes, require complex care for their chronic condition.&#xD;
      Parents usually provide a majority of their care and are often overwhelmed by the caregiving&#xD;
      demands resulting in deterioration of their own mental and physical health. The goal of this&#xD;
      2-arm (intervention vs. attention control) RCT is to test a cognitive-behavioral&#xD;
      Resourcefulness Training intervention that includes teaching social (help-seeking) and&#xD;
      personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers&#xD;
      of technology-dependent children describing resourcefulness skill application in daily life;&#xD;
      4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the&#xD;
      first 4 weeks; and booster sessions at 2 and 4 months post enrollment. The intervention is&#xD;
      proposed to improve these caregivers' mental and physical health outcomes and family&#xD;
      functioning outcomes while they continue to provide vital care for these vulnerable children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Technology-dependent children, those who rely on medical equipment such as mechanical&#xD;
      ventilation or feeding tubes for daily care at home, are among the sickest and most&#xD;
      vulnerable subset of children with complex chronic conditions. An estimated 600,000 children&#xD;
      in the United States are technology dependent and live at home, and are cared for primarily&#xD;
      by their parents. These parents report greater levels of depressive symptoms and stress than&#xD;
      other caregiver groups. In addition, these caregivers report poor psychological and physical&#xD;
      health that compromise their caregiving capacity and increase their use of emergency rooms&#xD;
      (ER) for their children's care needs. Despite these adverse consequences, there are no&#xD;
      interventions to meet the needs of these caregivers and their children. Resourcefulness&#xD;
      Training, (cognitive-behavioral self-management intervention) has been shown to improve&#xD;
      psychological and physical outcomes, mediate the effects of stress, and enhance the care&#xD;
      provided to care-recipients. It will be tested in a randomized trial against an&#xD;
      attention-only control arm. The intervention arm will receive an intervention that includes:&#xD;
      a face-to-face session for teaching social (help-seeking) and personal (self-help)&#xD;
      resourcefulness skills; ongoing access to video vignettes of caregivers of&#xD;
      technology-dependent children describing resourcefulness skill application in daily life; 4&#xD;
      weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first&#xD;
      4 weeks; and booster sessions at 2 and 4 months post enrollment. The Attention Control arm&#xD;
      will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment&#xD;
      plus any usual care. The aims of the study are to: 1) Determine whether Resourcefulness&#xD;
      Training versus Attention Control improves psychological (general mental health, depressive&#xD;
      cognitions, depressive symptoms, appraised stress, burden) and physical outcomes (general&#xD;
      physical health, chronic stress [hair cortisol]) and family functioning over 6 months in&#xD;
      parents of technology-dependent children, after controlling for the parents' race/ethnicity,&#xD;
      sex, family income, and children's functional status; and 2) Determine whether changes in&#xD;
      psychological and physical outcomes and family functioning are mediated by changes in&#xD;
      parents' levels of resourcefulness (personal and social). Data collection will take place at&#xD;
      baseline then 6 weeks, 3 months, and 6 months post-enrollment. Our study will be the first to&#xD;
      test a resourcefulness intervention for this caregiver population and to include male as well&#xD;
      as female caregivers. This intervention is distinctive in that it uses web, telephone, and&#xD;
      journal components for reinforcement-not multiple face-to-face visits that can be labor&#xD;
      intensive. If shown to be efficacious, it can be easily replicated with other populations&#xD;
      with strong potential for translation into practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2018</start_date>
  <completion_date type="Actual">December 9, 2019</completion_date>
  <primary_completion_date type="Actual">December 9, 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>
    <intervention_model_description>2-arm RCT with participants randomized to either the intervention or attention control group.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depressive Cognitions Scale</measure>
    <time_frame>From baseline to 6 weeks, 3 months, and 6 months post-enrollment</time_frame>
    <description>Subjective measure of participant depressive cognitions- precursor of depressive symptoms. Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Outcomes Short Form Health Survey (SF-12) Physical Health</measure>
    <time_frame>From baseline to 6 weeks, 3 months, and 6 months post-enrollment</time_frame>
    <description>Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Outcomes Short Form Health Survey (SF-12) Mental Health</measure>
    <time_frame>From baseline to 6 weeks, 3 months, and 6 months post-enrollment</time_frame>
    <description>Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feetham Family Functioning Survey</measure>
    <time_frame>From baseline to 6 weeks, 3 months, and 6 months post-enrollment</time_frame>
    <description>Change in Family Functioning from Baseline to 6 Months Post Enrollment. This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the &quot;differences&quot; between reality and life expectations. Higher 'Difference' score indicates an imbalance between reality and life expectations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resourcefulness Scale</measure>
    <time_frame>From baseline to 6 weeks, 3 months, and 6 months post-enrollment</time_frame>
    <description>Subjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Depressive Symptoms</condition>
  <condition>Multiple Chronic Conditions</condition>
  <condition>Family Caregivers</condition>
  <arm_group>
    <arm_group_label>Resourcefulness Training Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resourcefulness Training</intervention_name>
    <description>Cognitive-behavioral intervention that includes personal and social resourcefulness skills.</description>
    <arm_group_label>Resourcefulness Training Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parent caregiver (biological, adoptive, or foster mother, father, grandmother or&#xD;
             grandfather) for a technology-dependent child based on the Office of Technology&#xD;
             Assessment (OTA) classification criteria (Group 1, mechanical ventilator; Group 2,&#xD;
             intravenous nutrition/medication; Group 3 respiratory or nutritional support)&#xD;
&#xD;
          -  at least 18 years of age&#xD;
&#xD;
          -  able to speak and understand English due to the availability of the intervention and&#xD;
             instruments in English only&#xD;
&#xD;
          -  the technology-dependent child must be age 17 years or younger and receive care in the&#xD;
             home from his/her parent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents of children with a cancer diagnosis will be excluded from participation due to&#xD;
             the potentially life-threatening, terminal nature of the illness and grief reactions&#xD;
             associated with a cancer diagnosis that may limit their ability to participate over&#xD;
             the 6 month study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valerie A Toly, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Frances Payne Bolton School of Nursing, Case Western Reserve University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106-5065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <results_first_submitted>December 21, 2020</results_first_submitted>
  <results_first_submitted_qc>September 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 25, 2021</results_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Valerie Toly</investigator_full_name>
    <investigator_title>Assistant Professor- UH Research Associate</investigator_title>
  </responsible_party>
  <keyword>Parents</keyword>
  <keyword>Technology-Dependent Child</keyword>
  <keyword>Resourcefulness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
    <mesh_term>Multiple Chronic Conditions</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The study team is still conducting analysis and writing up study results for publication.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03301831/Prot_SAP_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Resourcefulness Training Intervention</title>
          <description>The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.&#xD;
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.</description>
        </group>
        <group group_id="P2">
          <title>Attention Control</title>
          <description>The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Resourcefulness Training Intervention</title>
          <description>The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.&#xD;
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.</description>
        </group>
        <group group_id="B2">
          <title>Attention Control</title>
          <description>The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="46"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="93"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.5" spread="9.9"/>
                    <measurement group_id="B2" value="38.7" spread="10.8"/>
                    <measurement group_id="B3" value="39.1" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>General Physical Health</title>
          <description>Subjective Measure that is part of SF-12 survey that participants complete. The score range is 0-100, 0 indicates lowest level of health, 100 indicates highest level of health.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.32" lower_limit="27.33" upper_limit="67.74"/>
                    <measurement group_id="B2" value="49.48" lower_limit="29.86" upper_limit="63.95"/>
                    <measurement group_id="B3" value="50.4" lower_limit="27.33" upper_limit="67.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>General Mental Health</title>
          <description>General Mental Health is a subjective survey that is part of the SF-12 Scale completed by participants. The score range is 0-100, 0 indicates lowest level of health, 100 indicates highest level of health.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.6" lower_limit="23.28" upper_limit="64.75"/>
                    <measurement group_id="B2" value="42.45" lower_limit="17.48" upper_limit="60.68"/>
                    <measurement group_id="B3" value="42.5" lower_limit="17.48" upper_limit="64.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Center for Epidemiological Studies- Depression</title>
          <description>This is commonly know as the CES-D. It is a subjective measure of depressive symptoms. Data is obtained via survey of participants. The score range is 0-60, Higher score indicates the presence of more symptomatology (more depressive symptoms).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19" lower_limit="1" upper_limit="45"/>
                    <measurement group_id="B2" value="18.04" lower_limit="1" upper_limit="41"/>
                    <measurement group_id="B3" value="18.5" lower_limit="1" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Resourcefulness Scale</title>
          <description>This subjective measure is collected via participant surveys. Score range is 0-140, higher score indicates greater resourcefulness.</description>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84.96" lower_limit="51" upper_limit="129"/>
                    <measurement group_id="B2" value="87.52" lower_limit="35" upper_limit="123"/>
                    <measurement group_id="B3" value="86.24" lower_limit="35" upper_limit="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Depressive Cognitions Scale</title>
          <description>This is a subjective measure that is collected from participants via survey. Score range is 0-40, Higher Score indicates greater depressive cognition.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.7" lower_limit="0" upper_limit="28"/>
                    <measurement group_id="B2" value="8.4" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="B3" value="8.03" lower_limit="0" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Feetham Family Functioning Survey</title>
          <description>This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the &quot;differences&quot; between reality and life expectations.&#xD;
Higher 'Difference' score indicates an imbalance between reality and life expectations</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.63" spread="29.39"/>
                    <measurement group_id="B2" value="39.57" spread="24.91"/>
                    <measurement group_id="B3" value="41.58" spread="27.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Zarit Burden Scale</title>
          <description>This is a subjective measure collected via participant survey. Score range is 0-48, higher score indicates greater burden.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.1" lower_limit="0" upper_limit="38"/>
                    <measurement group_id="B2" value="19.9" lower_limit="2" upper_limit="39"/>
                    <measurement group_id="B3" value="20" lower_limit="0" upper_limit="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Depressive Cognitions Scale</title>
        <description>Subjective measure of participant depressive cognitions- precursor of depressive symptoms. Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition.</description>
        <time_frame>From baseline to 6 weeks, 3 months, and 6 months post-enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resourcefulness Training Intervention</title>
            <description>The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.&#xD;
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control</title>
            <description>The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Depressive Cognitions Scale</title>
          <description>Subjective measure of participant depressive cognitions- precursor of depressive symptoms. Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition.</description>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Weeks Post Enrollment Timepoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.46" lower_limit="0" upper_limit="21"/>
                    <measurement group_id="O2" value="6.97" lower_limit="0" upper_limit="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Months Post Enrollment Timepoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.32" lower_limit="0" upper_limit="23"/>
                    <measurement group_id="O2" value="7.28" lower_limit="0" upper_limit="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months Post Enrollment Timepoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.65" lower_limit="0" upper_limit="23"/>
                    <measurement group_id="O2" value="7.93" lower_limit="0" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Medical Outcomes Short Form Health Survey (SF-12) Physical Health</title>
        <description>Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.</description>
        <time_frame>From baseline to 6 weeks, 3 months, and 6 months post-enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resourcefulness Training Intervention</title>
            <description>The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.&#xD;
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control</title>
            <description>The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Medical Outcomes Short Form Health Survey (SF-12) Physical Health</title>
          <description>Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.</description>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Weeks Post Enrollement Timepoint 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.7" lower_limit="27" upper_limit="64.74"/>
                    <measurement group_id="O2" value="50.77" lower_limit="28.26" upper_limit="66.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Months Post Enrollment Timepoint 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.49" lower_limit="28.39" upper_limit="67.02"/>
                    <measurement group_id="O2" value="49.46" lower_limit="23.19" upper_limit="65.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months Post Enrollment Timepoint 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.49" lower_limit="24.78" upper_limit="64.96"/>
                    <measurement group_id="O2" value="49.81" lower_limit="24.43" upper_limit="62.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Medical Outcomes Short Form Health Survey (SF-12) Mental Health</title>
        <description>Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.</description>
        <time_frame>From baseline to 6 weeks, 3 months, and 6 months post-enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resourcefulness Training Intervention</title>
            <description>The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.&#xD;
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control</title>
            <description>The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Medical Outcomes Short Form Health Survey (SF-12) Mental Health</title>
          <description>Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.</description>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Weeks Post-Enrollment, Timepoint 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.02" lower_limit="22.17" upper_limit="63.97"/>
                    <measurement group_id="O2" value="45.69" lower_limit="17.8" upper_limit="61.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Months Post-Enrollment, Timepoint 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.54" lower_limit="26.17" upper_limit="63.5"/>
                    <measurement group_id="O2" value="47.41" lower_limit="28.67" upper_limit="64.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Weeks Post-Enrollment, Timepoint 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.51" lower_limit="26.17" upper_limit="63.89"/>
                    <measurement group_id="O2" value="46.79" lower_limit="15.15" upper_limit="62.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Feetham Family Functioning Survey</title>
        <description>Change in Family Functioning from Baseline to 6 Months Post Enrollment. This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the &quot;differences&quot; between reality and life expectations. Higher 'Difference' score indicates an imbalance between reality and life expectations</description>
        <time_frame>From baseline to 6 weeks, 3 months, and 6 months post-enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resourcefulness Training Intervention</title>
            <description>The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.&#xD;
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control</title>
            <description>The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Feetham Family Functioning Survey</title>
          <description>Change in Family Functioning from Baseline to 6 Months Post Enrollment. This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the &quot;differences&quot; between reality and life expectations. Higher 'Difference' score indicates an imbalance between reality and life expectations</description>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Weeks Post Enrollment Timepoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.96" spread="22.01"/>
                    <measurement group_id="O2" value="36.38" spread="22.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Months Post Enrollment Timepoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.26" spread="22.83"/>
                    <measurement group_id="O2" value="37.44" spread="24.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months Post Enrollment Timepoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.30" spread="23.66"/>
                    <measurement group_id="O2" value="32.43" spread="19.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Resourcefulness Scale</title>
        <description>Subjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness.</description>
        <time_frame>From baseline to 6 weeks, 3 months, and 6 months post-enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resourcefulness Training Intervention</title>
            <description>The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.&#xD;
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.</description>
          </group>
          <group group_id="O2">
            <title>Attention Control</title>
            <description>The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.</description>
          </group>
        </group_list>
        <measure>
          <title>Resourcefulness Scale</title>
          <description>Subjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness.</description>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Weeks Post Enrollment Timepoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.12" lower_limit="50" upper_limit="125"/>
                    <measurement group_id="O2" value="93.59" lower_limit="58" upper_limit="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Months Post Enrollment Timepoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.47" lower_limit="60" upper_limit="102"/>
                    <measurement group_id="O2" value="88.22" lower_limit="40" upper_limit="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months Post Enrollment Timepoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.17" lower_limit="22" upper_limit="121"/>
                    <measurement group_id="O2" value="93.59" lower_limit="58" upper_limit="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>No adverse events were reported during the 6 month data collection period.</time_frame>
      <desc>The definitions do not differ in this context because no adverse events or serious adverse events were reported during the 6 month data collection period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Resourcefulness Training Intervention</title>
          <description>The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.&#xD;
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.</description>
        </group>
        <group group_id="E2">
          <title>Attention Control</title>
          <description>The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Valerie Boebel Toly, PhD, RN, CPNP</name_or_title>
      <organization>Case Western Reserve University</organization>
      <phone>(216) 368-3082</phone>
      <email>vab@case.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03301831
org study id: 08-10-30
secondary id: 1R15NR017302-01
nct id: NCT03301831
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Technology-dependent children, those who live at home but rely on medical equipment such as
      mechanical ventilation or feeding tubes, require complex care for their chronic condition.
      Parents usually provide a majority of their care and are often overwhelmed by the caregiving
      demands resulting in deterioration of their own mental and physical health. The goal of this
      2-arm (intervention vs. attention control) RCT is to test a cognitive-behavioral
      Resourcefulness Training intervention that includes teaching social (help-seeking) and
      personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers
      of technology-dependent children describing resourcefulness skill application in daily life;
      4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the
      first 4 weeks; and booster sessions at 2 and 4 months post enrollment. The intervention is
      proposed to improve these caregivers' mental and physical health outcomes and family
      functioning outcomes while they continue to provide vital care for these vulnerable children.
Technology-dependent children, those who rely on medical equipment such as mechanical
      ventilation or feeding tubes for daily care at home, are among the sickest and most
      vulnerable subset of children with complex chronic conditions. An estimated 600,000 children
      in the United States are technology dependent and live at home, and are cared for primarily
      by their parents. These parents report greater levels of depressive symptoms and stress than
      other caregiver groups. In addition, these caregivers report poor psychological and physical
      health that compromise their caregiving capacity and increase their use of emergency rooms
      (ER) for their children's care needs. Despite these adverse consequences, there are no
      interventions to meet the needs of these caregivers and their children. Resourcefulness
      Training, (cognitive-behavioral self-management intervention) has been shown to improve
      psychological and physical outcomes, mediate the effects of stress, and enhance the care
      provided to care-recipients. It will be tested in a randomized trial against an
      attention-only control arm. The intervention arm will receive an intervention that includes:
      a face-to-face session for teaching social (help-seeking) and personal (self-help)
      resourcefulness skills; ongoing access to video vignettes of caregivers of
      technology-dependent children describing resourcefulness skill application in daily life; 4
      weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first
      4 weeks; and booster sessions at 2 and 4 months post enrollment. The Attention Control arm
      will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment
      plus any usual care. The aims of the study are to: 1) Determine whether Resourcefulness
      Training versus Attention Control improves psychological (general mental health, depressive
      cognitions, depressive symptoms, appraised stress, burden) and physical outcomes (general
      physical health, chronic stress [hair cortisol]) and family functioning over 6 months in
      parents of technology-dependent children, after controlling for the parents' race/ethnicity,
      sex, family income, and children's functional status; and 2) Determine whether changes in
      psychological and physical outcomes and family functioning are mediated by changes in
      parents' levels of resourcefulness (personal and social). Data collection will take place at
      baseline then 6 weeks, 3 months, and 6 months post-enrollment. Our study will be the first to
      test a resourcefulness intervention for this caregiver population and to include male as well
      as female caregivers. This intervention is distinctive in that it uses web, telephone, and
      journal components for reinforcement-not multiple face-to-face visits that can be labor
      intensive. If shown to be efficacious, it can be easily replicated with other populations
      with strong potential for translation into practice.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2-arm RCT with participants randomized to either the intervention or attention control group.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Depressive Cognitions Scale
time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
description: Subjective measure of participant depressive cognitions- precursor of depressive symptoms. Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition.
measure: Medical Outcomes Short Form Health Survey (SF-12) Physical Health
time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
description: Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
measure: Medical Outcomes Short Form Health Survey (SF-12) Mental Health
time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
description: Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
measure: Feetham Family Functioning Survey
time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
description: Change in Family Functioning from Baseline to 6 Months Post Enrollment. This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the "differences" between reality and life expectations. Higher 'Difference' score indicates an imbalance between reality and life expectations
measure: Resourcefulness Scale
time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
description: Subjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness.
arm group label: Resourcefulness Training Intervention
arm group type: Experimental
description: The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
arm group label: Attention Control
arm group type: No Intervention
description: The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
intervention type: Behavioral
intervention name: Resourcefulness Training
description: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
arm group label: Resourcefulness Training Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Valerie A Toly, PhD
role: Principal Investigator
affiliation: Frances Payne Bolton School of Nursing, Case Western Reserve University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Valerie Toly
investigator title: Assistant Professor- UH Research Associate
mesh term: Chronic Disease
mesh term: Multiple Chronic Conditions
mesh term: Depression
sharing ipd: No
ipd description: The study team is still conducting analysis and writing up study results for publication.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 