Quality of Life Clinical Trial
Official title:
Social Intelligence Training for Custodial Grandmothers and Their Adolescent Grandchildren
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,
Status | Recruiting |
Enrollment | 680 |
Est. completion date | October 31, 2022 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Kent State University | Kent | Ohio |
Lead Sponsor | Collaborator |
---|---|
Kent State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Open Ended Interviews | To be created open-ended measure of treatment satisfaction | Within one month after completing the social intelligence intervention. | |
Primary | Change in Composite Latent Construct "Social Sensitivity" | Measured by four standardized instruments self-report scales and daily diary entries | Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention. | |
Primary | Change in Composite Latent Construct "Openness to Others" | Measured by two standardized self-report scales | Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention | |
Primary | Change in Composite Latent Construct "Social Self-Confidence" | Measured by three standardized self-report instruments | Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention | |
Primary | Change in Composite Latent Construct "Relationships and Social Ties" | Measures of ambivalence, close relationships, positive family connections, relationships with important groups; and social connections with peers. | Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention | |
Primary | Change in Physical Health | Self-reported health status measured by the Sf-12 Survey | Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention | |
Primary | Change in Composite Latent Construct "Psychological and Emotional Well-Being" | Separate measures of self-esteem, loneliness, depression, anxiety, introversion-extroversion, affective reactivity, social resilience | Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention |
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