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临床试验/NCT03239977
NCT03239977Unknown2 期

Social Intelligence Training for Custodial Grandmothers and Their Adolescent Grandchildren

Kent State University2 个研究点 分布在 1 个国家目标入组 680 人开始时间: 2018年5月31日最近更新:
适应症

试验速览

阶段
2 期
入组人数
680
试验地点
2
主要终点
Change in Composite Latent Construct "Social Sensitivity"

研究概览

简要总结

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,

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Change in Composite Latent Construct "Social Sensitivity"

时间窗: 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

Change in Composite Latent Construct "Psychological and Emotional Well-Being"

时间窗: 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

Change in Composite Latent Construct "Openness to Others"

时间窗: 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

Change in Composite Latent Construct "Social Self-Confidence"

时间窗: 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

Change in Composite Latent Construct "Relationships and Social Ties"

时间窗: 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.

Change in Physical Health

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory Smith

Professor

Kent State University

研究点 (2)

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