- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03824353
Social Intelligence Training in Midlife
Does Resilience to Childhood Adversity Improve With Social Intelligence Training
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult living in the US age 40 and older
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Placebo Comparator: Attention Control
The attention control condition, known as The Healthy Living program provides information about different aspects of health.
|
A placebo condition delivered online which presents health-related information only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 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
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 will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.
|
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 will be assessed from baseline immeidately post intervention, as well as at 3, and 6 month post intervention.
|
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
|
Change will be assessed from baseline immeidately post intervention. A composite score will be created based on 16 items.
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01AG048844 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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