Emotional IntelligencePhase 2NCT03239977
Social Intelligence Training for Custodial Grandfamilies
A Phase 2 study testing Online Social Intelligence Training in people with Emotional Intelligence and Quality of Life, run by Kent State University at 1 site in United States.
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, Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Intelligence, Quality of Life, Social Competence
- What is being tested?
- Online Social Intelligence Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 680 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2018to 31 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Cognitive or behavioral problems that limit the ability of grandmothers and grandchildren to comprehend the intervention and complete study measures
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kent State University
Kent, Ohio, 44242
Gregory C Smith, EdD
About this study
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,
Read the 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.
- Conditions
- Emotional Intelligence, Quality of Life, Social Competence
- Being tested
- Online Social Intelligence Training, Attention Control (AC)
- Keywords
- social intelligence, quality of life, social competence
- Medical subject headings
- Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Social Intelligence TrainingBehavioural
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)Behavioural
A placebo condition delivered online to both custodial grandmothers and their adolescent grandchild which presents health-related information only.
| Study group | Role | What they receive |
|---|---|---|
| Online Social Intelligence Training | Experimental | 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. Receives: Behavioral: Online Social Intelligence Training |
| Attention Control (AC) | Placebo comparator | The attention control (AC) condition, known as The Healthy Living program provides information about different aspects of health. Receives: Behavioral: Attention Control (AC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Latent Construct "Social Sensitivity"
Measured by four standardized instruments self-report scales and daily diary entries
Measured: 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"
Measured by two standardized self-report scales
Measured: 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"
Measured by three standardized self-report instruments
Measured: 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"
Measures of ambivalence, close relationships, positive family connections, relationships with important groups; and social connections with peers.
Measured: Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
Change in Physical Health
Self-reported health status measured by the Sf-12 Survey
Measured: 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"
Separate measures of self-esteem, loneliness, depression, anxiety, introversion-extroversion, affective reactivity, social resilience
Measured: Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start31 May 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emotional IntelligenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Smith, Kent State University
- Investigators
- Gregory C Smith, EdD, Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239977
- Sponsor's protocol ID
- GCSmith RCT NIA
- Status last verified
- Aug 2020
- First submitted
- 24 Jul 2017
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Infurna FJ, Castro SA, Webster BA, Dolbin-MacNab ML, Smith GC, Crowley DM, Musil C. Does Social Intelligence Training Improve Daily Well-Being and Responsiveness to Daily Negative and Positive Events in Custodial Grandmothers? J Gerontol B Psychol Sci Soc Sci. 2024 Jul 1;79(7):gbae069. doi: 10.1093/geronb/gbae069.
PubMed 38695191Smith GC, Infurna FJ, Dolbin-MacNab M, Webster B, Castro S, Crowley DM, Musil C, Hu L, Hancock GR. A Randomized Clinical Trial of Online Social Intelligence Training With Custodial Grandmothers. Gerontologist. 2024 May 1;64(5):gnad079. doi: 10.1093/geront/gnad079.
PubMed 37354201
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Intelligence Training for Custodial Grandmothers and Their Adolescent Grandchildren
- ClinicalTrials.gov ID
- NCT03239977
- Acronym / sponsor ID
- GCSmith RCT NIA
- Conditions
- Emotional Intelligence, Quality of Life, Social Competence
- Keywords
- social intelligence, quality of life, social competence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Longitudinal Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Online Social Intelligence Training | Experimental | Behavioral: Online Social Intelligence TrainingThe 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. |
| Attention Control (AC) | Placebo comparator | Behavioral: Attention Control (AC)The attention control (AC) condition, known as The Healthy Living program provides information about different aspects of health. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Cognitive or behavioral problems that limit the ability of grandmothers and grandchildren to comprehend the intervention and complete study measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Social Intelligence TrainingThe 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. | Behavioural | Online Social Intelligence Training |
| Attention Control (AC)A placebo condition delivered online to both custodial grandmothers and their adolescent grandchild which presents health-related information only. | Behavioural | Attention Control (AC) |
Primary outcome
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 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 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 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 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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 38695191Infurna FJ, Castro SA, Webster BA, Dolbin-MacNab ML, Smith GC, Crowley DM, Musil C. Does Social Intelligence Training Improve Daily Well-Being and Responsiveness to Daily Negative and Positive Events in Custodial Grandmothers? J Gerontol B Psychol Sci Soc Sci. 2024 Jul 1;79(7):gbae069. doi: 10.1093/geronb/gbae069.
- Derived from this study: PubMed 37354201Smith GC, Infurna FJ, Dolbin-MacNab M, Webster B, Castro S, Crowley DM, Musil C, Hu L, Hancock GR. A Randomized Clinical Trial of Online Social Intelligence Training With Custodial Grandmothers. Gerontologist. 2024 May 1;64(5):gnad079. doi: 10.1093/geront/gnad079.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory C Smith, EdD principal investigator
Kent State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Online Social Intelligence Training in people with Emotional Intelligence and Quality of Life, run by Kent State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregory C Smith, EdD (330 672-9993, gsmith2@kent.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03239977, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.