NCT03824353

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2014

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

3.6 years

First QC Date

January 28, 2019

Last Update Submit

January 30, 2019

Conditions

Social SkillsSocial Interaction

Outcome Measures

Primary Outcomes (4)

  • Change in social socio-emotion regulation.

    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

    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.

    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

    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.

Study Arms (2)

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.

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.

Behavioral: The Healthy Living Program

Interventions

Social Intelligence TrainingBEHAVIORAL

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.

Social Intelligence Training
The Healthy Living ProgramBEHAVIORAL

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

Attention Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult living in the US age 40 and older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 36870019DERIVED

  • 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.

    PMID: 30999262DERIVED

MeSH Terms

Conditions

Social Skills

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 31, 2019

Study Start

September 30, 2014

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01