<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/NCT03824353</url>
  </required_header>
  <id_info>
    <org_study_id>R01AG048844</org_study_id>
    <nct_id>NCT03824353</nct_id>
  </id_info>
  <brief_title>Social Intelligence Training in Midlife</brief_title>
  <official_title>Does Resilience to Childhood Adversity Improve With Social Intelligence Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Arizona State University</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>
      Childhood adversity leads to social difficulties, chronic illness, and early mortality for&#xD;
      many, but not all adults: Some are resilient. The investigators will test whether an on-line&#xD;
      program focused on enhancing social relationships for people in mid-life can increase the&#xD;
      odds that those with a history of a troubled childhood will not suffer a greater loss in&#xD;
      mental and physical health than those without those histories. The investigators findings&#xD;
      will bring the field significantly closer to the day when low cost interventions can be&#xD;
      offered that work to strengthen the capacities of people to overcome the challenges that&#xD;
      arise from adverse treatment early in life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is indisputable that health declines with age, and that the rate of decline is not the&#xD;
      same for everyone. Many sources of accelerated risk of illness have been identified in prior&#xD;
      research, and among the most reliable predictors of ill health are social stressors,&#xD;
      including abusive social relations in childhood. Early life adversity may lead to poorer&#xD;
      mental health and physical functioning in midlife through various pathways; among the most&#xD;
      likely paths are social in origin, including troubled family relationships, heightened&#xD;
      sensitivity to interpersonal stressors, and social isolation. Is it possible to interrupt&#xD;
      this cause-effect pairing between early adversity and illness in later life? The&#xD;
      investigators examine that question. Specifically, the investigators address whether the&#xD;
      individual differences in risk attributable to childhood adversity are reversible through a&#xD;
      social intelligence (SI) intervention for an established cohort of community residents who&#xD;
      were part of a comprehensive study of biopsychosocial markers of resilience at Mid-Life. The&#xD;
      investigators have three primary objectives in this research:&#xD;
&#xD;
        1. To examine whether an SI intervention can enhance the capacity for rewarding social&#xD;
           relations, especially for individuals with a history of early life adversity.&#xD;
&#xD;
        2. To examine evidence for the investigator's hypothesis that intervention-related gains in&#xD;
           the quality of social relationship will be responsible for the improvements in&#xD;
           psychological, and physical functioning, and influence two bio-markers of health risk&#xD;
           and resilience: interleukin 6 (IL-6) and DHEA-S.&#xD;
&#xD;
        3. To probe for individual differences in age, gender, history of abuse, personality, and&#xD;
           genetic markers of risk that identify participants most responsive to the intervention.&#xD;
&#xD;
      To address these questions, an SI intervention will be delivered to a random-selected half of&#xD;
      220 middle-aged participants: Half with a history of child abuse and half who did not report&#xD;
      abuse. The program is an on-line self-instructional series of videos with awareness exercises&#xD;
      and behavioral practices designed to enhance fund of knowledge about relationships, increase&#xD;
      skills, and enhance motivation to engage socially. In addition to charting social relations&#xD;
      with daily diaries, the investigators will assess participants' social, psychological, and&#xD;
      physical functioning at pre-test, post-test, three months, and six months following the&#xD;
      intervention. The investigators hypothesize that the SI intervention will prompt lasting&#xD;
      improvement in the ability to establish, maintain, and benefit from social relations in&#xD;
      comparison to controls, which will lead to better psychological and physical functioning. The&#xD;
      investigators will examine evidence for the hypothesis that the benefits of the intervention&#xD;
      will be largest for individuals who have experienced greater early childhood adversity, as&#xD;
      well as probe other individual differences in receptivity to the SI program that will inform&#xD;
      future efforts to refine, test and disseminate this innovative program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2014</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in social socio-emotion regulation.</measure>
    <time_frame>Change will be assessed from baseline immeidately post intervention. This will be measured with four separate items that are on the same scale.</time_frame>
    <description>Measured by standardized instruments in daily diary entries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in social intelligence</measure>
    <time_frame>Change will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.</time_frame>
    <description>Measured by a standardized instrument in the self-report questionnaires. We used the Tromso Social Intelligence Scale to assess social intelligence. The scale is comprised of 3 factors (social skills, social information processing, and social awareness). Each scale ranges from 1 to 5.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in social support and strain.</measure>
    <time_frame>Change will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.</time_frame>
    <description>Measured by a standardized instrument in the self-report questionnaires. We used the assessment tool described in Walen and Lachman (2000).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in well-being</measure>
    <time_frame>Change will be assessed from baseline immeidately post intervention. A composite score will be created based on 16 items.</time_frame>
    <description>Measured by standardized instruments in daily diaries</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Social Skills</condition>
  <condition>Social Interaction</condition>
  <arm_group>
    <arm_group_label>Social Intelligence Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The social intelligence training is delivered online to individuals in midlife (ages 40 and older). This is the sole active treatment condition within this RCT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The attention control 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>Social Intelligence Training</intervention_name>
    <description>The social intelligence training 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 social intelligence training 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>Social Intelligence Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Healthy Living Program</intervention_name>
    <description>A placebo condition delivered online which presents health-related information only.</description>
    <arm_group_label>Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult living in the US age 40 and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03824353
org study id: R01AG048844
nct id: NCT03824353
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Childhood adversity leads to social difficulties, chronic illness, and early mortality for
      many, but not all adults: Some are resilient. The investigators will test whether an on-line
      program focused on enhancing social relationships for people in mid-life can increase the
      odds that those with a history of a troubled childhood will not suffer a greater loss in
      mental and physical health than those without those histories. The investigators findings
      will bring the field significantly closer to the day when low cost interventions can be
      offered that work to strengthen the capacities of people to overcome the challenges that
      arise from adverse treatment early in life.
It is indisputable that health declines with age, and that the rate of decline is not the
      same for everyone. Many sources of accelerated risk of illness have been identified in prior
      research, and among the most reliable predictors of ill health are social stressors,
      including abusive social relations in childhood. Early life adversity may lead to poorer
      mental health and physical functioning in midlife through various pathways; among the most
      likely paths are social in origin, including troubled family relationships, heightened
      sensitivity to interpersonal stressors, and social isolation. Is it possible to interrupt
      this cause-effect pairing between early adversity and illness in later life? The
      investigators examine that question. Specifically, the investigators address whether the
      individual differences in risk attributable to childhood adversity are reversible through a
      social intelligence (SI) intervention for an established cohort of community residents who
      were part of a comprehensive study of biopsychosocial markers of resilience at Mid-Life. The
      investigators have three primary objectives in this research:

        1. To examine whether an SI intervention can enhance the capacity for rewarding social
           relations, especially for individuals with a history of early life adversity.

        2. To examine evidence for the investigator's hypothesis that intervention-related gains in
           the quality of social relationship will be responsible for the improvements in
           psychological, and physical functioning, and influence two bio-markers of health risk
           and resilience: interleukin 6 (IL-6) and DHEA-S.

        3. To probe for individual differences in age, gender, history of abuse, personality, and
           genetic markers of risk that identify participants most responsive to the intervention.

      To address these questions, an SI intervention will be delivered to a random-selected half of
      220 middle-aged participants: Half with a history of child abuse and half who did not report
      abuse. The program is an on-line self-instructional series of videos with awareness exercises
      and behavioral practices designed to enhance fund of knowledge about relationships, increase
      skills, and enhance motivation to engage socially. In addition to charting social relations
      with daily diaries, the investigators will assess participants' social, psychological, and
      physical functioning at pre-test, post-test, three months, and six months following the
      intervention. The investigators hypothesize that the SI intervention will prompt lasting
      improvement in the ability to establish, maintain, and benefit from social relations in
      comparison to controls, which will lead to better psychological and physical functioning. The
      investigators will examine evidence for the hypothesis that the benefits of the intervention
      will be largest for individuals who have experienced greater early childhood adversity, as
      well as probe other individual differences in receptivity to the SI program that will inform
      future efforts to refine, test and disseminate this innovative program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in social socio-emotion regulation.
time frame: Change will be assessed from baseline immeidately post intervention. This will be measured with four separate items that are on the same scale.
description: Measured by standardized instruments in daily diary entries
measure: Change in social intelligence
time frame: Change will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.
description: Measured by a standardized instrument in the self-report questionnaires. We used the Tromso Social Intelligence Scale to assess social intelligence. The scale is comprised of 3 factors (social skills, social information processing, and social awareness). Each scale ranges from 1 to 5.
measure: Change in social support and strain.
time frame: Change will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.
description: Measured by a standardized instrument in the self-report questionnaires. We used the assessment tool described in Walen and Lachman (2000).
measure: Change in well-being
time frame: Change will be assessed from baseline immeidately post intervention. A composite score will be created based on 16 items.
description: Measured by standardized instruments in daily diaries
arm group label: Social Intelligence Training
arm group type: Experimental
description: The social intelligence training is delivered online to individuals in midlife (ages 40 and older). This is the sole active treatment condition within this RCT.
arm group label: Attention Control
arm group type: Placebo Comparator
description: The attention control condition, known as The Healthy Living program provides information about different aspects of health.
intervention type: Behavioral
intervention name: Social Intelligence Training
description: The social intelligence training 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 social intelligence training 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: Social Intelligence Training
intervention type: Behavioral
intervention name: The Healthy Living Program
description: A placebo condition delivered online which presents health-related information only.
arm group label: Attention Control
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: Undecided