<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/NCT03292692</url>
  </required_header>
  <id_info>
    <org_study_id>20120378</org_study_id>
    <secondary_id>R01HD059802</secondary_id>
    <nct_id>NCT03292692</nct_id>
  </id_info>
  <brief_title>Empirically-Based Couple Interventions on the Web: Serving the Underserved</brief_title>
  <official_title>Empirically-Based Couple Interventions on the Web: Serving the Underserved</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</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>
      Although several empirically-supported interventions to prevent and treat relationship&#xD;
      distress have been developed, the majority of couples - especially high-risk couples - do not&#xD;
      seek these face-to-face interventions. However, our pilot data indicate that large numbers of&#xD;
      couples will seek self-administered assistance for their relationship. Additionally, unlike&#xD;
      many in-person interventions, couples seeking self-help resources tend to have higher levels&#xD;
      of relationship distress. Thus, to improve the reach of couple interventions, this project&#xD;
      will translate a leading empirically-supported intervention targeting early signs of&#xD;
      relationship distress into a Web-based format. This intervention will consist of&#xD;
      individualized feedback and professionally-filmed video clips tailored to a couple's specific&#xD;
      needs. By intervening effectively with a large number of couples, the resulting Web-based&#xD;
      intervention has the potential to have a population-level impact on relationship distress,&#xD;
      divorce, and resulting child difficulties.&#xD;
&#xD;
      In the proposed project, building off our previous pilot studies, effective translation of&#xD;
      this in-person intervention into a Web-based format will be ensured by conducting two&#xD;
      additional intensive pilot studies. Once final changes have been made to the website and&#xD;
      Web-based intervention, 300 couples will be randomly assigned to a wait-list control group or&#xD;
      an online intervention. All couples will be assessed for the initial two months; intervention&#xD;
      couples will be assessed for one year. This project will: 1) demonstrate that couples&#xD;
      randomly assigned to the online intervention will report higher levels of individual, child,&#xD;
      and relationship functioning than those in the wait-list control group; 2) document the&#xD;
      mechanisms of both active conditions; and 3) show that initial gains in those assigned to the&#xD;
      intervention are largely maintained through one-year follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2013</start_date>
  <completion_date type="Actual">October 18, 2014</completion_date>
  <primary_completion_date type="Actual">October 18, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relationship Satisfaction</measure>
    <time_frame>Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)</time_frame>
    <description>Relationship satisfaction as measured by the total scale on the four-item version of the Couple Satisfaction Index (Funk &amp; Rogge, 2007; doi: 10.1037/0893-3200.21.4.572). Scores on this measure range from 0-21, with higher scores indicating greater satisfaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship Confidence</measure>
    <time_frame>Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)</time_frame>
    <description>Relationship confidence as measured by 2 items from the Confidence Scale (&quot;I believe we can handle whatever conflicts will arise in the future&quot; and &quot;I feel good about our prospects to make this relationship work&quot;). Scored ranged from 0 to 12, with higher scores indicate more confidence.Cronbach's alpha = .88. These two items have been used in previous studies of couples to assess change (e.g., http://dx.doi .org/10.1177/0192513X08324388).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>Pre (0 weeks) and Post (approximately 6 weeks)</time_frame>
    <description>Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies-Depression (CES-D) Scale (Cole, Rabin, Smith, &amp; Kaufman, 2004). The total score was used, with possible scores ranging from 0-30. Higher scores on this measure indicate greater depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Symptoms</measure>
    <time_frame>Pre (0 weeks) and Post (approximately 6 weeks)</time_frame>
    <description>Anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, &amp; Löwe, 2006). The range of the measure is 0 to 49, with higher scores indicating greater anxiety symptoms. Cronbach's alpha in the present sample was .91.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Relationship, Marital</condition>
  <condition>Marital Conflict</condition>
  <arm_group>
    <arm_group_label>OurRelationship</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Online Intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>2 month waiting period before couples can receive intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>OurRelationship</intervention_name>
    <description>Online intervention with coach support</description>
    <arm_group_label>OurRelationship</arm_group_label>
    <other_name>OurRelationship.com</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently in a heterosexual relationship&#xD;
&#xD;
          -  Currently married, engaged, or cohabiting for at least 6 months&#xD;
&#xD;
          -  At least one partner scoring in distressed range of relationship satisfaction (or both&#xD;
             partners &gt; 0.5 SD of population mean of distress).&#xD;
&#xD;
          -  Living in the United States&#xD;
&#xD;
          -  Both partners ages 21-64 (inclusive)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Intimate Partner Violence in last 3 months&#xD;
&#xD;
          -  Moderate to severe suicidal ideation in last 3 months&#xD;
&#xD;
          -  Concrete plans to divorce&#xD;
&#xD;
          -  Ongoing affair&#xD;
&#xD;
          -  Ongoing couple therapy (or refusal to seek couple therapy for 3 months)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Doss BD, Cicila LN, Georgia EJ, Roddy MK, Nowlan KM, Benson LA, Christensen A. A randomized controlled trial of the web-based OurRelationship program: Effects on relationship and individual functioning. J Consult Clin Psychol. 2016 Apr;84(4):285-96. doi: 10.1037/ccp0000063. Epub 2016 Jan 25.</citation>
    <PMID>26999504</PMID>
  </results_reference>
  <results_reference>
    <citation>Roddy MK, Georgia EJ, Doss BD. Couples with Intimate Partner Violence Seeking Relationship Help: Associations and Implications for Self-Help and Online Interventions. Fam Process. 2018 Jun;57(2):293-307. doi: 10.1111/famp.12291. Epub 2017 Apr 20.</citation>
    <PMID>28425562</PMID>
  </results_reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>October 23, 2017</results_first_submitted>
  <results_first_submitted_qc>February 8, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 12, 2018</results_first_posted>
  <last_update_submitted>February 8, 2018</last_update_submitted>
  <last_update_submitted_qc>February 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Brian Doss</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data available to qualified researchers upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Available 2018-2020</ipd_time_frame>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>OurRelationship</title>
          <description>Online Intervention&#xD;
OurRelationship: Online intervention with coach support</description>
        </group>
        <group group_id="P2">
          <title>Waitlist Control</title>
          <description>2 month waiting period before couples can receive intervention</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="302"/>
                <participants group_id="P2" count="298"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="264"/>
                <participants group_id="P2" count="260"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>OurRelationship</title>
          <description>Online Intervention&#xD;
OurRelationship: Online intervention with coach support</description>
        </group>
        <group group_id="B2">
          <title>Waitlist Control</title>
          <description>2 month waiting period before couples can receive intervention</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="302"/>
            <count group_id="B2" value="298"/>
            <count group_id="B3" value="600"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="36.01" spread="9.54"/>
                    <measurement group_id="B2" value="36.22" spread="9.62"/>
                    <measurement group_id="B3" value="36.11" spread="9.58"/>
                  </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="151"/>
                    <measurement group_id="B2" value="149"/>
                    <measurement group_id="B3" value="300"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="151"/>
                    <measurement group_id="B2" value="149"/>
                    <measurement group_id="B3" value="300"/>
                  </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="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="272"/>
                    <measurement group_id="B2" value="269"/>
                    <measurement group_id="B3" value="541"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_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="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="209"/>
                    <measurement group_id="B2" value="212"/>
                    <measurement group_id="B3" value="421"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                    <measurement group_id="B2" value="298"/>
                    <measurement group_id="B3" value="600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Relationship Satisfaction</title>
        <description>Relationship satisfaction as measured by the total scale on the four-item version of the Couple Satisfaction Index (Funk &amp; Rogge, 2007; doi: 10.1037/0893-3200.21.4.572). Scores on this measure range from 0-21, with higher scores indicating greater satisfaction.</description>
        <time_frame>Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OurRelationship</title>
            <description>Online Intervention&#xD;
OurRelationship: Online intervention with coach support</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Control</title>
            <description>2 month waiting period before couples can receive intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Relationship Satisfaction</title>
          <description>Relationship satisfaction as measured by the total scale on the four-item version of the Couple Satisfaction Index (Funk &amp; Rogge, 2007; doi: 10.1037/0893-3200.21.4.572). Scores on this measure range from 0-21, with higher scores indicating greater satisfaction.</description>
          <units>units 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="302"/>
                <count group_id="O2" value="298"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.335" spread="3.915"/>
                    <measurement group_id="O2" value="8.37" spread="4.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.63" spread="4.335"/>
                    <measurement group_id="O2" value="9.555" spread="4.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.08" spread="4.42"/>
                    <measurement group_id="O2" value="9.51" spread="4.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Linear</method>
            <method_desc>Multi-level regression</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.372</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.279</ci_lower_limit>
            <ci_upper_limit>0.465</ci_upper_limit>
            <estimate_desc>Slope of intervention group compared to slope of the control group</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relationship Confidence</title>
        <description>Relationship confidence as measured by 2 items from the Confidence Scale (&quot;I believe we can handle whatever conflicts will arise in the future&quot; and &quot;I feel good about our prospects to make this relationship work&quot;). Scored ranged from 0 to 12, with higher scores indicate more confidence.Cronbach's alpha = .88. These two items have been used in previous studies of couples to assess change (e.g., http://dx.doi .org/10.1177/0192513X08324388).</description>
        <time_frame>Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OurRelationship</title>
            <description>Online Intervention&#xD;
OurRelationship: Online intervention with coach support</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Control</title>
            <description>2 month waiting period before couples can receive intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Relationship Confidence</title>
          <description>Relationship confidence as measured by 2 items from the Confidence Scale (&quot;I believe we can handle whatever conflicts will arise in the future&quot; and &quot;I feel good about our prospects to make this relationship work&quot;). Scored ranged from 0 to 12, with higher scores indicate more confidence.Cronbach's alpha = .88. These two items have been used in previous studies of couples to assess change (e.g., http://dx.doi .org/10.1177/0192513X08324388).</description>
          <units>units 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="302"/>
                <count group_id="O2" value="298"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.94" spread="2.565"/>
                    <measurement group_id="O2" value="7.58" spread="3.185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.92" spread="2.495"/>
                    <measurement group_id="O2" value="8.045" spread="3.215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.635" spread="2.325"/>
                    <measurement group_id="O2" value="8.05" spread="3.335"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Linear</method>
            <method_desc>Multilevel linear modeling</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.170</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.105</ci_lower_limit>
            <ci_upper_limit>0.235</ci_upper_limit>
            <estimate_desc>Slope of the intervention group compared to slope of the control group</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depressive Symptoms</title>
        <description>Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies-Depression (CES-D) Scale (Cole, Rabin, Smith, &amp; Kaufman, 2004). The total score was used, with possible scores ranging from 0-30. Higher scores on this measure indicate greater depressive symptoms.</description>
        <time_frame>Pre (0 weeks) and Post (approximately 6 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OurRelationship</title>
            <description>Online Intervention&#xD;
OurRelationship: Online intervention with coach support</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Control</title>
            <description>2 month waiting period before couples can receive intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Depressive Symptoms</title>
          <description>Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies-Depression (CES-D) Scale (Cole, Rabin, Smith, &amp; Kaufman, 2004). The total score was used, with possible scores ranging from 0-30. Higher scores on this measure indicate greater depressive symptoms.</description>
          <units>units 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="302"/>
                <count group_id="O2" value="298"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.82" spread="4.24"/>
                    <measurement group_id="O2" value="10.42" spread="4.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.105" spread="3.22"/>
                    <measurement group_id="O2" value="9.895" spread="4.185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Linear</method>
            <method_desc>Multilevel linear regression</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.149</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.974</ci_lower_limit>
            <ci_upper_limit>-1.324</ci_upper_limit>
            <estimate_desc>Multilevel linear modeling, with time modeled as change from pre-post.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxiety Symptoms</title>
        <description>Anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, &amp; Löwe, 2006). The range of the measure is 0 to 49, with higher scores indicating greater anxiety symptoms. Cronbach's alpha in the present sample was .91.</description>
        <time_frame>Pre (0 weeks) and Post (approximately 6 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>OurRelationship</title>
            <description>Online Intervention&#xD;
OurRelationship: Online intervention with coach support</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Control</title>
            <description>2 month waiting period before couples can receive intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety Symptoms</title>
          <description>Anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, &amp; Löwe, 2006). The range of the measure is 0 to 49, with higher scores indicating greater anxiety symptoms. Cronbach's alpha in the present sample was .91.</description>
          <units>units 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="302"/>
                <count group_id="O2" value="298"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.995" spread="5.385"/>
                    <measurement group_id="O2" value="8.24" spread="5.645"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.875" spread="4.5"/>
                    <measurement group_id="O2" value="6.11" spread="5.135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.144</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.871</ci_lower_limit>
            <ci_upper_limit>-0.417</ci_upper_limit>
            <estimate_desc>Multilevel linear modeling, with time modeled as change from pre to post.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>OurRelationship</title>
          <description>Online Intervention&#xD;
OurRelationship: Online intervention with coach support</description>
        </group>
        <group group_id="E2">
          <title>Waitlist Control</title>
          <description>2 month waiting period before couples can receive intervention</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="302"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="302"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="298"/>
              </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>Dr. Brian Doss</name_or_title>
      <organization>University of Miami</organization>
      <phone>305-284-1101</phone>
      <email>bdoss@miami.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/NCT03292692
org study id: 20120378
secondary id: R01HD059802
nct id: NCT03292692
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although several empirically-supported interventions to prevent and treat relationship
      distress have been developed, the majority of couples - especially high-risk couples - do not
      seek these face-to-face interventions. However, our pilot data indicate that large numbers of
      couples will seek self-administered assistance for their relationship. Additionally, unlike
      many in-person interventions, couples seeking self-help resources tend to have higher levels
      of relationship distress. Thus, to improve the reach of couple interventions, this project
      will translate a leading empirically-supported intervention targeting early signs of
      relationship distress into a Web-based format. This intervention will consist of
      individualized feedback and professionally-filmed video clips tailored to a couple's specific
      needs. By intervening effectively with a large number of couples, the resulting Web-based
      intervention has the potential to have a population-level impact on relationship distress,
      divorce, and resulting child difficulties.

      In the proposed project, building off our previous pilot studies, effective translation of
      this in-person intervention into a Web-based format will be ensured by conducting two
      additional intensive pilot studies. Once final changes have been made to the website and
      Web-based intervention, 300 couples will be randomly assigned to a wait-list control group or
      an online intervention. All couples will be assessed for the initial two months; intervention
      couples will be assessed for one year. This project will: 1) demonstrate that couples
      randomly assigned to the online intervention will report higher levels of individual, child,
      and relationship functioning than those in the wait-list control group; 2) document the
      mechanisms of both active conditions; and 3) show that initial gains in those assigned to the
      intervention are largely maintained through one-year follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Relationship Satisfaction
time frame: Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
description: Relationship satisfaction as measured by the total scale on the four-item version of the Couple Satisfaction Index (Funk & Rogge, 2007; doi: 10.1037/0893-3200.21.4.572). Scores on this measure range from 0-21, with higher scores indicating greater satisfaction.
measure: Relationship Confidence
time frame: Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
description: Relationship confidence as measured by 2 items from the Confidence Scale ("I believe we can handle whatever conflicts will arise in the future" and "I feel good about our prospects to make this relationship work"). Scored ranged from 0 to 12, with higher scores indicate more confidence.Cronbach's alpha = .88. These two items have been used in previous studies of couples to assess change (e.g., http://dx.doi .org/10.1177/0192513X08324388).
measure: Depressive Symptoms
time frame: Pre (0 weeks) and Post (approximately 6 weeks)
description: Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies-Depression (CES-D) Scale (Cole, Rabin, Smith, & Kaufman, 2004). The total score was used, with possible scores ranging from 0-30. Higher scores on this measure indicate greater depressive symptoms.
measure: Anxiety Symptoms
time frame: Pre (0 weeks) and Post (approximately 6 weeks)
description: Anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006). The range of the measure is 0 to 49, with higher scores indicating greater anxiety symptoms. Cronbach's alpha in the present sample was .91.
arm group label: OurRelationship
arm group type: Experimental
description: Online Intervention
arm group label: Waitlist Control
arm group type: No Intervention
description: 2 month waiting period before couples can receive intervention
intervention type: Behavioral
intervention name: OurRelationship
description: Online intervention with coach support
arm group label: OurRelationship
other name: OurRelationship.com
criteria: 
gender: All
minimum age: 21 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Doss BD, Cicila LN, Georgia EJ, Roddy MK, Nowlan KM, Benson LA, Christensen A. A randomized controlled trial of the web-based OurRelationship program: Effects on relationship and individual functioning. J Consult Clin Psychol. 2016 Apr;84(4):285-96. doi: 10.1037/ccp0000063. Epub 2016 Jan 25.
PMID: 26999504
citation: Roddy MK, Georgia EJ, Doss BD. Couples with Intimate Partner Violence Seeking Relationship Help: Associations and Implications for Self-Help and Online Interventions. Fam Process. 2018 Jun;57(2):293-307. doi: 10.1111/famp.12291. Epub 2017 Apr 20.
PMID: 28425562
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Brian Doss
investigator title: Associate Professor
sharing ipd: Yes
ipd description: De-identified data available to qualified researchers upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Available 2018-2020
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 