- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03239977
Social Intelligence Training for Custodial Grandfamilies
August 31, 2020 updated by: Gregory Smith, Kent State University
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,
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
680
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gregory C Smith, EdD
- Phone Number: 330 672-9993
- Email: gsmith2@kent.edu
Study Locations
-
-
Ohio
-
Kent, Ohio, United States, 44242
- Recruiting
- Kent State University
-
Contact:
- Gregory C Smith, EdD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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.
|
A placebo condition delivered online to both custodial grandmothers and their adolescent grandchild which presents health-related information only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention.
|
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
|
Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
|
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
|
Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
|
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.
|
Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
|
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
|
Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
|
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
|
Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Open Ended Interviews
Time Frame: Within one month after completing the social intelligence intervention.
|
To be created open-ended measure of treatment satisfaction
|
Within one month after completing the social intelligence intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gregory C Smith, EdD, Kent State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 31, 2018
Primary Completion (ANTICIPATED)
December 30, 2021
Study Completion (ANTICIPATED)
October 31, 2022
Study Registration Dates
First Submitted
July 24, 2017
First Submitted That Met QC Criteria
August 1, 2017
First Posted (ACTUAL)
August 4, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 2, 2020
Last Update Submitted That Met QC Criteria
August 31, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- GCSmith RCT NIA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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