Social SkillsPhase 2NCT03824353
Social Intelligence Training in Midlife
A Phase 2 study testing Social Intelligence Training and The Healthy Living Program in people with Social Skills and Social Interaction, run by Arizona State University.
Trial summary
Childhood adversity leads to social difficulties, chronic illness, and early mortality for many, but not all adults: Some are resilient. The investigators will test whether an on-line program focused on enhancing social relationships for people in mid-life can increase the odds that those with a history of a troubled… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Skills, Social Interaction
- What is being tested?
- Social Intelligence Training and The Healthy Living Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2014to 30 Apr 2018
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult living in the US age 40 and older
Who cannot join
- -
About this study
Official title: Does Resilience to Childhood Adversity Improve With Social Intelligence Training
Childhood adversity leads to social difficulties, chronic illness, and early mortality for many, but not all adults: Some are resilient. The investigators will test whether an on-line program focused on enhancing social relationships for people in mid-life can increase the odds that those with a history of a troubled childhood will not suffer a greater loss in mental and physical health than those without those histories. The investigators findings will bring the field significantly closer to the day when low cost interventions can be offered that work to strengthen the capacities of people to overcome the challenges that arise from adverse treatment early in life.
Read the detailed description
It is indisputable that health declines with age, and that the rate of decline is not the same for everyone. Many sources of accelerated risk of illness have been identified in prior research, and among the most reliable predictors of ill health are social stressors, including abusive social relations in childhood. Early life adversity may lead to poorer mental health and physical functioning in midlife through various pathways; among the most likely paths are social in origin, including troubled family relationships, heightened sensitivity to interpersonal stressors, and social isolation. Is it possible to interrupt this cause-effect pairing between early adversity and illness in later life? The investigators examine that question. Specifically, the investigators address whether the individual differences in risk attributable to childhood adversity are reversible through a social intelligence (SI) intervention for an established cohort of community residents who were part of a comprehensive study of biopsychosocial markers of resilience at Mid-Life. The investigators have three primary objectives in this research:
- To examine whether an SI intervention can enhance the capacity for rewarding social relations, especially for individuals with a history of early life adversity.
- To examine evidence for the investigator's hypothesis that intervention-related gains in the quality of social relationship will be responsible for the improvements in psychological, and physical functioning, and influence two bio-markers of health risk and resilience: interleukin 6 (IL-6) and DHEA-S.
- To probe for individual differences in age, gender, history of abuse, personality, and genetic markers of risk that identify participants most responsive to the intervention.
To address these questions, an SI intervention will be delivered to a random-selected half of 220 middle-aged participants: Half with a history of child abuse and half who did not report abuse. The program is an on-line self-instructional series of videos with awareness exercises and behavioral practices designed to enhance fund of knowledge about relationships, increase skills, and enhance motivation to engage socially. In addition to charting social relations with daily diaries, the investigators will assess participants' social, psychological, and physical functioning at pre-test, post-test, three months, and six months following the intervention. The investigators hypothesize that the SI intervention will prompt lasting improvement in the ability to establish, maintain, and benefit from social relations in comparison to controls, which will lead to better psychological and physical functioning. The investigators will examine evidence for the hypothesis that the benefits of the intervention will be largest for individuals who have experienced greater early childhood adversity, as well as probe other individual differences in receptivity to the SI program that will inform future efforts to refine, test and disseminate this innovative program.
- Conditions
- Social Skills, Social Interaction
- Being tested
- Social Intelligence Training, The Healthy Living Program
- Medical subject headings
- Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Intelligence TrainingBehavioural
The social intelligence training 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 social intelligence training is best advanced through interventions that modify key social cognitions regarding social engagement and enhance efficacy expectations regarding performance in social situations.
The Healthy Living ProgramBehavioural
A placebo condition delivered online which presents health-related information only.
| Study group | Role | What they receive |
|---|---|---|
| Social Intelligence Training | Experimental | The social intelligence training is delivered online to individuals in midlife (ages 40 and older). This is the sole active treatment condition within this RCT. Receives: Behavioral: Social Intelligence Training |
| Attention Control | Placebo comparator | The attention control condition, known as The Healthy Living program provides information about different aspects of health. Receives: Behavioral: The Healthy Living Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in social socio-emotion regulation.
Measured by standardized instruments in daily diary entries
Measured: Change will be assessed from baseline immeidately post intervention. This will be measured with four separate items that are on the same scale.
Change in social intelligence
Measured by a standardized instrument in the self-report questionnaires. We used the Tromso Social Intelligence Scale to assess social intelligence. The scale is comprised of 3 factors (social skills, social information processing, and social awareness). Each scale ranges from 1 to 5.
Measured: Change will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.
Change in social support and strain.
Measured by a standardized instrument in the self-report questionnaires. We used the assessment tool described in Walen and Lachman (2000).
Measured: Change will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.
Change in well-being
Measured by standardized instruments in daily diaries
Measured: Change will be assessed from baseline immeidately post intervention. A composite score will be created based on 16 items.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start30 Sep 2014
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
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 Social SkillsStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824353
- Sponsor's protocol ID
- R01AG048844
- Status last verified
- Jan 2019
- First submitted
- 28 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Castro SA, Infurna FJ, Lemery-Chalfant K, Waldron VR, Zautra E. Are Daily Well-Being and Emotional Reactivity to Stressors Modifiable in Midlife?: Evidence from a Randomized Controlled Trial of an Online Social Intelligence Training Program. Prev Sci. 2023 Jul;24(5):841-851. doi: 10.1007/s11121-023-01492-7. Epub 2023 Mar 4.
PubMed 36870019Castro SA, Infurna FJ, Lemery-Chalfant K, Waldron V, Zautra E. Can an online curriculum improve the daily socio-emotional lives of middle-aged adults exposed to childhood Trauma? Behav Res Ther. 2019 Jul;118:65-76. doi: 10.1016/j.brat.2019.03.012. Epub 2019 Mar 24.
PubMed 30999262
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Resilience to Childhood Adversity Improve With Social Intelligence Training
- ClinicalTrials.gov ID
- NCT03824353
- Acronym / sponsor ID
- R01AG048844
- Conditions
- Social Skills, Social Interaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 31 Jan 2019 (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.
Childhood adversity leads to social difficulties, chronic illness, and early mortality for many, but not all adults: Some are resilient. The investigators will test whether an on-line program focused on enhancing social relationships for people in mid-life can increase the odds that those with a history of a troubled childhood will not suffer a greater loss in mental and physical health than those without those histories. The investigators findings will bring the field significantly closer to the day when low cost interventions can be offered that work to strengthen the capacities of people to overcome the challenges that arise from adverse treatment early in life.
Detailed description
It is indisputable that health declines with age, and that the rate of decline is not the same for everyone. Many sources of accelerated risk of illness have been identified in prior research, and among the most reliable predictors of ill health are social stressors, including abusive social relations in childhood. Early life adversity may lead to poorer mental health and physical functioning in midlife through various pathways; among the most likely paths are social in origin, including troubled family relationships, heightened sensitivity to interpersonal stressors, and social isolation. Is it possible to interrupt this cause-effect pairing between early adversity and illness in later life? The investigators examine that question. Specifically, the investigators address whether the individual differences in risk attributable to childhood adversity are reversible through a social intelligence (SI) intervention for an established cohort of community residents who were part of a comprehensive study of biopsychosocial markers of resilience at Mid-Life. The investigators have three primary objectives in this research:
- To examine whether an SI intervention can enhance the capacity for rewarding social relations, especially for individuals with a history of early life adversity.
- To examine evidence for the investigator's hypothesis that intervention-related gains in the quality of social relationship will be responsible for the improvements in psychological, and physical functioning, and influence two bio-markers of health risk and resilience: interleukin 6 (IL-6) and DHEA-S.
- To probe for individual differences in age, gender, history of abuse, personality, and genetic markers of risk that identify participants most responsive to the intervention.
To address these questions, an SI intervention will be delivered to a random-selected half of 220 middle-aged participants: Half with a history of child abuse and half who did not report abuse. The program is an on-line self-instructional series of videos with awareness exercises and behavioral practices designed to enhance fund of knowledge about relationships, increase skills, and enhance motivation to engage socially. In addition to charting social relations with daily diaries, the investigators will assess participants' social, psychological, and physical functioning at pre-test, post-test, three months, and six months following the intervention. The investigators hypothesize that the SI intervention will prompt lasting improvement in the ability to establish, maintain, and benefit from social relations in comparison to controls, which will lead to better psychological and physical functioning. The investigators will examine evidence for the hypothesis that the benefits of the intervention will be largest for individuals who have experienced greater early childhood adversity, as well as probe other individual differences in receptivity to the SI program that will inform future efforts to refine, test and disseminate this innovative program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Intelligence Training | Experimental | Behavioral: Social Intelligence TrainingThe social intelligence training is delivered online to individuals in midlife (ages 40 and older). This is the sole active treatment condition within this RCT. |
| Attention Control | Placebo comparator | Behavioral: The Healthy Living ProgramThe attention control condition, known as The Healthy Living program provides information about different aspects of health. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult living in the US age 40 and older
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Social Intelligence TrainingThe social intelligence training 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 social intelligence training is best advanced through interventions that modify key social cognitions regarding social engagement and enhance efficacy expectations regarding performance in social situations. | Behavioural | Social Intelligence Training |
| The Healthy Living ProgramA placebo condition delivered online which presents health-related information only. | Behavioural | Attention Control |
Primary outcome
Change in social socio-emotion regulation.
Time frame: Change will be assessed from baseline immeidately post intervention. This will be measured with four separate items that are on the same scale.
Measured by standardized instruments in daily diary entries
Change in social intelligence
Time frame: Change will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.
Measured by a standardized instrument in the self-report questionnaires. We used the Tromso Social Intelligence Scale to assess social intelligence. The scale is comprised of 3 factors (social skills, social information processing, and social awareness). Each scale ranges from 1 to 5.
Change in social support and strain.
Time frame: Change will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.
Measured by a standardized instrument in the self-report questionnaires. We used the assessment tool described in Walen and Lachman (2000).
Change in well-being
Time frame: Change will be assessed from baseline immeidately post intervention. A composite score will be created based on 16 items.
Measured by standardized instruments in daily diaries
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Derived from this study: PubMed 36870019Castro SA, Infurna FJ, Lemery-Chalfant K, Waldron VR, Zautra E. Are Daily Well-Being and Emotional Reactivity to Stressors Modifiable in Midlife?: Evidence from a Randomized Controlled Trial of an Online Social Intelligence Training Program. Prev Sci. 2023 Jul;24(5):841-851. doi: 10.1007/s11121-023-01492-7. Epub 2023 Mar 4.
- Derived from this study: PubMed 30999262Castro SA, Infurna FJ, Lemery-Chalfant K, Waldron V, Zautra E. Can an online curriculum improve the daily socio-emotional lives of middle-aged adults exposed to childhood Trauma? Behav Res Ther. 2019 Jul;118:65-76. doi: 10.1016/j.brat.2019.03.012. Epub 2019 Mar 24.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Social Intelligence Training and The Healthy Living Program in people with Social Skills and Social Interaction, run by Arizona State University.
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 1 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: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in social socio-emotion regulation. (time frame: Change will be assessed from baseline immeidately post intervention. This will be measured with four separate items that are on the same scale.). The study lists 4 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 NCT03824353, 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 1 Feb 2019.