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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03239977
Other study ID # GCSmith RCT NIA
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 31, 2018
Est. completion date October 31, 2022

Study information

Verified date August 2020
Source Kent State University
Contact Gregory C Smith, EdD
Phone 330 672-9993
Email gsmith2@kent.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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,


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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.
Attention Control (AC)
A placebo condition delivered online to both custodial grandmothers and their adolescent grandchild which presents health-related information only.

Locations

Country Name City State
United States Kent State University Kent Ohio

Sponsors (1)

Lead Sponsor Collaborator
Kent State University

Country where clinical trial is conducted

United States, 

Outcome

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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