ClinicalTrials.gg
CompletedNCT03824353Updated Feb 1, 2019

Social Intelligence Training in Midlife

A Phase 2 interventional study of Social Intelligence Training and The Healthy Living Program in Social Skills and Social Interaction, sponsored by Arizona State University. Completed. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by Arizona State University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Sep 2014, registered Jan 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
40 Years and older
Sex
All
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Study 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 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:

  1. To examine whether an SI intervention can enhance the capacity for rewarding social relations, especially for individuals with a history of early life adversity.
  2. 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.
  3. 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.

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Conditions studied

  • Social Skills
  • Social Interaction

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In context

Social Skills

35 studies on the registry are indexed under Social Skills; 15 are open to participants now.

This study's enrollment of 240 is above the median of 60 across 31 interventional studies indexed under Social Skills.

Browse Social Skills studies →

Lead sponsor

Arizona State University is the lead sponsor of 235 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult living in the US age 40 and older

Exclusion criteria

Exclusion Criteria:

-

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    Social Intelligence Training

    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.

    Behavioral: Social Intelligence Training

  • Placebo comparator
    Attention Control

    The attention control condition, known as The Healthy Living program provides information about different aspects of health.

    Behavioral: The Healthy Living Program

Interventions

  • BehavioralSocial Intelligence Training

    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.

  • BehavioralThe Healthy Living Program

    A placebo condition delivered online which presents health-related information only.

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What researchers measure

Primary outcomes

  1. Change in social socio-emotion regulation.

    Measured by standardized instruments in daily diary entries

    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.

  2. 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.

    Time frame: Change will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.

  3. 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).

    Time frame: Change will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.

  4. Change in well-being

    Measured by standardized instruments in daily diaries

    Time frame: Change will be assessed from baseline immeidately post intervention. A composite score will be created based on 16 items.

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Study locations

No study locations are listed for this record.

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References and documents

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 36870019 ↗
  • Castro 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 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2014 to primary completion in Apr 2018, 43 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2019
First posted
Jan 31, 2019
StartActual
Sep 30, 2014
Primary completionActual
Apr 30, 2018
CompletionActual
Apr 30, 2018
Last update
Feb 1, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03824353
Responsible party
Sponsor
First posted
Jan 31, 2019
Start date
Sep 30, 2014
Primary completion
Apr 30, 2018
Completion
Apr 30, 2018
Last update
Feb 1, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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