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Social Intelligence Training for Custodial Grandfamilies

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ClinicalTrials.gov Identifier: NCT03239977
Recruitment Status : Recruiting
First Posted : August 4, 2017
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Gregory Smith, Kent State University

Brief Summary:
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,

Condition or disease Intervention/treatment Phase
Emotional Intelligence Quality of Life Social Competence Behavioral: Online Social Intelligence Training Behavioral: Attention Control (AC) Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Longitudinal Randomized Clinical Trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Social Intelligence Training for Custodial Grandmothers and Their Adolescent Grandchildren
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : October 31, 2022

Arm Intervention/treatment
Experimental: Online Social Intelligence Training
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.
Behavioral: Online Social Intelligence Training
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.

Placebo Comparator: Attention Control (AC)
The attention control (AC) condition, known as The Healthy Living program provides information about different aspects of health.
Behavioral: Attention Control (AC)
A placebo condition delivered online to both custodial grandmothers and their adolescent grandchild which presents health-related information only.




Primary Outcome Measures :
  1. 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. ]
    Measured by four standardized instruments self-report scales and daily diary entries

  2. 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 ]
    Measured by two standardized self-report scales

  3. 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 ]
    Measured by three standardized self-report instruments

  4. 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 ]
    Measures of ambivalence, close relationships, positive family connections, relationships with important groups; and social connections with peers.

  5. 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 ]
    Self-reported health status measured by the Sf-12 Survey

  6. 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 ]
    Separate measures of self-esteem, loneliness, depression, anxiety, introversion-extroversion, affective reactivity, social resilience


Other Outcome Measures:
  1. Open Ended Interviews [ Time Frame: Within one month after completing the social intelligence intervention. ]
    To be created open-ended measure of treatment satisfaction



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Grandmothers only will be eligible to participate
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Grandmothers of any age or race
  • Providing full-time care to an adolescent grandchild between ages 12-18
  • Providing care in their own residence
  • Providing care in total absence of the grandchild's biological parents.
  • The target adolescent custodial grandchild will be of either gender
  • Between ages 12- 18
  • The custodial grandmother has provided full-time care for at least 6 months in total absence of the biological parents.
  • Understanding of English well enough to comprehend all study materials.

Exclusion Criteria:

* Cognitive or behavioral problems that limit the ability of grandmothers and grandchildren to comprehend the intervention and complete study measures


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239977


Contacts
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Contact: Gregory C Smith, EdD 330 672-9993 gsmith2@kent.edu

Locations
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United States, Ohio
Kent State University Recruiting
Kent, Ohio, United States, 44242
Contact: Gregory C Smith, EdD         
Sponsors and Collaborators
Kent State University
Investigators
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Principal Investigator: Gregory C Smith, EdD Kent State University
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Responsible Party: Gregory Smith, Professor, Kent State University
ClinicalTrials.gov Identifier: NCT03239977    
Other Study ID Numbers: GCSmith RCT NIA
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gregory Smith, Kent State University:
social intelligence
quality of life
social competence