<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/NCT03239977</url>
  </required_header>
  <id_info>
    <org_study_id>GCSmith RCT NIA</org_study_id>
    <nct_id>NCT03239977</nct_id>
  </id_info>
  <brief_title>Social Intelligence Training for Custodial Grandfamilies</brief_title>
  <official_title>Social Intelligence Training for Custodial Grandmothers and Their Adolescent Grandchildren</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kent State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kent State University</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>
      This study is a randomized clinical trial designed to compare an online social intelligence&#xD;
      intervention with an active control condition at improving the emotional, physical, and&#xD;
      social well-being of custodial grandmothers and their adolescent grandchildren,&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators examine the efficacy of an online Social Intelligence Intervention (SII) at&#xD;
      improving the health and well-being of custodial grandmothers (CGMs) and their adolescent&#xD;
      custodial grandchildren (ACG) through mutual enhancement of their social competencies. This&#xD;
      target population is of particular importance because both CGMs and ACG experience&#xD;
      significant early life adversities that lead to hypervigilance of others, mistrust, social&#xD;
      isolation, interpersonal conflict, and the inability to garner warmth and support from family&#xD;
      and friends. Numerous studies have shown that these relational challenges within &quot;risky&#xD;
      families&quot; often lead to life-long interpersonal difficulties that increase the probability of&#xD;
      behavioral and physical health problems. Furthermore, adolescence is a key period for the&#xD;
      development of social competence, which is influenced by supportive caregiving and positive&#xD;
      modeling from female parent figures. However, because the ability of CGMs to carry out this&#xD;
      intergenerational transmission of social skills is challenged, examining joint social&#xD;
      intelligence training for CGM-ACG dyads is valuable for reversing this negative sequela. Yet,&#xD;
      to date, no other investigators have done so. To address this gap, ant an online randomized&#xD;
      clinical trial will be conducted with 340 nationally-recruited CGM-ACG (ages 12-18) dyads&#xD;
      assigned to either the SII or an attention control condition. Data will be obtained at pre-&#xD;
      and post-test, and at 3-, 6-, and 9-month follow-ups via questionnaires completed by phone.&#xD;
      Daily dairies will be collected online from 170 randomly selected dyads, and qualitative&#xD;
      interviews will be conducted with 60 dyads to probe how the SII affected their daily social&#xD;
      competence and social ties. We will obtain quantitative and qualitative measures of key&#xD;
      social cognitive processes, quality of close interpersonal ties, psychological well-being,&#xD;
      and physical health. Administrative medical, criminal, and education records for all 340&#xD;
      dyads will also be obtained for cost-benefit analyses that examine changes in burden on&#xD;
      public systems. These mixed-methods allow rigorous examination of four specific aims: (1) To&#xD;
      investigate if the SII enhances social competencies that, in turn, produce long-term changes&#xD;
      in relationship quality, well-being, and physical health; this includes determining if&#xD;
      increased social competence in one dyad member leads to partner effects in the other; (2) To&#xD;
      examine if cumulative risk, gender, and age moderate SII efficacy; (3) To study qualitatively&#xD;
      how CGM-ACG dyads view the SII as having changed their social competencies and yielded&#xD;
      positive outcomes; and (4) To assess the financial benefits of the SII to participants and&#xD;
      their communities. These aims address a highly significant public health problem that will&#xD;
      inform future efforts to support a wide range of high risk families, like custodial&#xD;
      grandfamilies, who typically have insufficient access to formal support services. This SII is&#xD;
      advantageous because it is inexpensive, delivered online, non-stigmatizing, and capable of&#xD;
      reaching a target population that is geographically disperse and greatly in need of&#xD;
      supportive programming.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 31, 2018</start_date>
  <completion_date type="Anticipated">October 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>Phase 2</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>Longitudinal Randomized Clinical Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Composite Latent Construct &quot;Social Sensitivity&quot;</measure>
    <time_frame>Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention.</time_frame>
    <description>Measured by four standardized instruments self-report scales and daily diary entries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Composite Latent Construct &quot;Openness to Others&quot;</measure>
    <time_frame>Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention</time_frame>
    <description>Measured by two standardized self-report scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Composite Latent Construct &quot;Social Self-Confidence&quot;</measure>
    <time_frame>Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention</time_frame>
    <description>Measured by three standardized self-report instruments</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Composite Latent Construct &quot;Relationships and Social Ties&quot;</measure>
    <time_frame>Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention</time_frame>
    <description>Measures of ambivalence, close relationships, positive family connections, relationships with important groups; and social connections with peers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Physical Health</measure>
    <time_frame>Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention</time_frame>
    <description>Self-reported health status measured by the Sf-12 Survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Composite Latent Construct &quot;Psychological and Emotional Well-Being&quot;</measure>
    <time_frame>Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention</time_frame>
    <description>Separate measures of self-esteem, loneliness, depression, anxiety, introversion-extroversion, affective reactivity, social resilience</description>
  </primary_outcome>
  <other_outcome>
    <measure>Open Ended Interviews</measure>
    <time_frame>Within one month after completing the social intelligence intervention.</time_frame>
    <description>To be created open-ended measure of treatment satisfaction</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">680</enrollment>
  <condition>Emotional Intelligence</condition>
  <condition>Quality of Life</condition>
  <condition>Social Competence</condition>
  <arm_group>
    <arm_group_label>Online Social Intelligence Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Social Intelligence Intervention (SII) is delivered online to both custodial grandmothers and their adolescent grandchild separately. This is the sole active treatment condition within this RCT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control (AC)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The attention control (AC) condition, known as The Healthy Living program provides information about different aspects of health.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online Social Intelligence Training</intervention_name>
    <description>The SII consists of short 5-10 minute sessions organized into 7 modules designed to raise awareness of human nature and social relationships. The approach is based on evidence that SII is best advanced through interventions that modify key social cognitions regarding social engagement and enhance efficacy expectations regarding performance in social situations.</description>
    <arm_group_label>Online Social Intelligence Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control (AC)</intervention_name>
    <description>A placebo condition delivered online to both custodial grandmothers and their adolescent grandchild which presents health-related information only.</description>
    <arm_group_label>Attention Control (AC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grandmothers of any age or race&#xD;
&#xD;
          -  Providing full-time care to an adolescent grandchild between ages 12-18&#xD;
&#xD;
          -  Providing care in their own residence&#xD;
&#xD;
          -  Providing care in total absence of the grandchild's biological parents.&#xD;
&#xD;
          -  The target adolescent custodial grandchild will be of either gender&#xD;
&#xD;
          -  Between ages 12- 18&#xD;
&#xD;
          -  The custodial grandmother has provided full-time care for at least 6 months in total&#xD;
             absence of the biological parents.&#xD;
&#xD;
          -  Understanding of English well enough to comprehend all study materials.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        * Cognitive or behavioral problems that limit the ability of grandmothers and grandchildren&#xD;
        to comprehend the intervention and complete study measures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Grandmothers only will be eligible to participate</gender_description>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory C Smith, EdD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kent State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gregory C Smith, EdD</last_name>
    <phone>330 672-9993</phone>
    <email>gsmith2@kent.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kent State University</name>
      <address>
        <city>Kent</city>
        <state>Ohio</state>
        <zip>44242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gregory C Smith, EdD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kent State University</investigator_affiliation>
    <investigator_full_name>Gregory Smith</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>social intelligence</keyword>
  <keyword>quality of life</keyword>
  <keyword>social competence</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03239977
org study id: GCSmith RCT NIA
nct id: NCT03239977
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a randomized clinical trial designed to compare an online social intelligence
      intervention with an active control condition at improving the emotional, physical, and
      social well-being of custodial grandmothers and their adolescent grandchildren,
The investigators examine the efficacy of an online Social Intelligence Intervention (SII) at
      improving the health and well-being of custodial grandmothers (CGMs) and their adolescent
      custodial grandchildren (ACG) through mutual enhancement of their social competencies. This
      target population is of particular importance because both CGMs and ACG experience
      significant early life adversities that lead to hypervigilance of others, mistrust, social
      isolation, interpersonal conflict, and the inability to garner warmth and support from family
      and friends. Numerous studies have shown that these relational challenges within "risky
      families" often lead to life-long interpersonal difficulties that increase the probability of
      behavioral and physical health problems. Furthermore, adolescence is a key period for the
      development of social competence, which is influenced by supportive caregiving and positive
      modeling from female parent figures. However, because the ability of CGMs to carry out this
      intergenerational transmission of social skills is challenged, examining joint social
      intelligence training for CGM-ACG dyads is valuable for reversing this negative sequela. Yet,
      to date, no other investigators have done so. To address this gap, ant an online randomized
      clinical trial will be conducted with 340 nationally-recruited CGM-ACG (ages 12-18) dyads
      assigned to either the SII or an attention control condition. Data will be obtained at pre-
      and post-test, and at 3-, 6-, and 9-month follow-ups via questionnaires completed by phone.
      Daily dairies will be collected online from 170 randomly selected dyads, and qualitative
      interviews will be conducted with 60 dyads to probe how the SII affected their daily social
      competence and social ties. We will obtain quantitative and qualitative measures of key
      social cognitive processes, quality of close interpersonal ties, psychological well-being,
      and physical health. Administrative medical, criminal, and education records for all 340
      dyads will also be obtained for cost-benefit analyses that examine changes in burden on
      public systems. These mixed-methods allow rigorous examination of four specific aims: (1) To
      investigate if the SII enhances social competencies that, in turn, produce long-term changes
      in relationship quality, well-being, and physical health; this includes determining if
      increased social competence in one dyad member leads to partner effects in the other; (2) To
      examine if cumulative risk, gender, and age moderate SII efficacy; (3) To study qualitatively
      how CGM-ACG dyads view the SII as having changed their social competencies and yielded
      positive outcomes; and (4) To assess the financial benefits of the SII to participants and
      their communities. These aims address a highly significant public health problem that will
      inform future efforts to support a wide range of high risk families, like custodial
      grandfamilies, who typically have insufficient access to formal support services. This SII is
      advantageous because it is inexpensive, delivered online, non-stigmatizing, and capable of
      reaching a target population that is geographically disperse and greatly in need of
      supportive programming.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Longitudinal Randomized Clinical Trial
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Change in Composite Latent Construct "Social Sensitivity"
time frame: Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention.
description: Measured by four standardized instruments self-report scales and daily diary entries
measure: Change in Composite Latent Construct "Openness to Others"
time frame: Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
description: Measured by two standardized self-report scales
measure: Change in Composite Latent Construct "Social Self-Confidence"
time frame: Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
description: Measured by three standardized self-report instruments
measure: Change in Composite Latent Construct "Relationships and Social Ties"
time frame: Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
description: Measures of ambivalence, close relationships, positive family connections, relationships with important groups; and social connections with peers.
measure: Change in Physical Health
time frame: Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
description: Self-reported health status measured by the Sf-12 Survey
measure: Change in Composite Latent Construct "Psychological and Emotional Well-Being"
time frame: Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
description: Separate measures of self-esteem, loneliness, depression, anxiety, introversion-extroversion, affective reactivity, social resilience
measure: Open Ended Interviews
time frame: Within one month after completing the social intelligence intervention.
description: To be created open-ended measure of treatment satisfaction
arm group label: Online Social Intelligence Training
arm group type: Experimental
description: The Social Intelligence Intervention (SII) is delivered online to both custodial grandmothers and their adolescent grandchild separately. This is the sole active treatment condition within this RCT.
arm group label: Attention Control (AC)
arm group type: Placebo Comparator
description: The attention control (AC) condition, known as The Healthy Living program provides information about different aspects of health.
intervention type: Behavioral
intervention name: Online Social Intelligence Training
description: The SII consists of short 5-10 minute sessions organized into 7 modules designed to raise awareness of human nature and social relationships. The approach is based on evidence that SII is best advanced through interventions that modify key social cognitions regarding social engagement and enhance efficacy expectations regarding performance in social situations.
arm group label: Online Social Intelligence Training
intervention type: Behavioral
intervention name: Attention Control (AC)
description: A placebo condition delivered online to both custodial grandmothers and their adolescent grandchild which presents health-related information only.
arm group label: Attention Control (AC)
criteria: 
gender: All
gender based: Yes
gender description: Grandmothers only will be eligible to participate
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory C Smith, EdD
role: Principal Investigator
affiliation: Kent State University
last name: Gregory C Smith, EdD
phone: 330 672-9993
email: gsmith2@kent.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Kent State University
investigator full name: Gregory Smith
investigator title: Professor
sharing ipd: No