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Social Intelligence Training in Midlife

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ClinicalTrials.gov Identifier: NCT03824353
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Arizona State University

Brief 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.

Condition or disease Intervention/treatment Phase
Social Skills Social Interaction Behavioral: Social Intelligence Training Behavioral: The Healthy Living Program Phase 2

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Resilience to Childhood Adversity Improve With Social Intelligence Training
Actual Study Start Date : September 30, 2014
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

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.
Behavioral: Social 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.

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




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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).

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult living in the US age 40 and older

Exclusion Criteria:

-

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT03824353    
Other Study ID Numbers: R01AG048844 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No