NCT03239977

Brief Summary

This study is a randomized clinical trial designed to compare an online social intelligence intervention with an active control condition at improving the emotional, physical, and social well-being of custodial grandmothers and their adolescent grandchildren,

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
680

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

3.6 years

First QC Date

July 24, 2017

Last Update Submit

August 31, 2020

Conditions

Keywords

social intelligencequality of lifesocial competence

Outcome Measures

Primary Outcomes (6)

  • Change in Composite Latent Construct "Social Sensitivity"

    Measured by four standardized instruments self-report scales and daily diary entries

    Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention.

  • Change in Composite Latent Construct "Openness to Others"

    Measured by two standardized self-report scales

    Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention

  • Change in Composite Latent Construct "Social Self-Confidence"

    Measured by three standardized self-report instruments

    Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention

  • Change in Composite Latent Construct "Relationships and Social Ties"

    Measures of ambivalence, close relationships, positive family connections, relationships with important groups; and social connections with peers.

    Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention

  • Change in Physical Health

    Self-reported health status measured by the Sf-12 Survey

    Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention

  • Change in Composite Latent Construct "Psychological and Emotional Well-Being"

    Separate measures of self-esteem, loneliness, depression, anxiety, introversion-extroversion, affective reactivity, social resilience

    Change will be assessed from baseline immediately post intervention, as well as at 3, 6, and 9 months post intervention

Other Outcomes (1)

  • Open Ended Interviews

    Within one month after completing the social intelligence intervention.

Study Arms (2)

Online Social Intelligence Training

EXPERIMENTAL

The Social Intelligence Intervention (SII) is delivered online to both custodial grandmothers and their adolescent grandchild separately. This is the sole active treatment condition within this RCT.

Behavioral: Online Social Intelligence Training

Attention Control (AC)

PLACEBO COMPARATOR

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

Behavioral: Attention Control (AC)

Interventions

The SII 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 SII is best advanced through interventions that modify key social cognitions regarding social engagement and enhance efficacy expectations regarding performance in social situations.

Online Social Intelligence Training

A placebo condition delivered online to both custodial grandmothers and their adolescent grandchild which presents health-related information only.

Attention Control (AC)

Eligibility Criteria

Age12 Years - 18 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGrandmothers only will be eligible to participate
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Grandmothers of any age or race
  • Providing full-time care to an adolescent grandchild between ages 12-18
  • Providing care in their own residence
  • Providing care in total absence of the grandchild's biological parents.
  • The target adolescent custodial grandchild will be of either gender
  • Between ages 12- 18
  • The custodial grandmother has provided full-time care for at least 6 months in total absence of the biological parents.
  • Understanding of English well enough to comprehend all study materials.

You may not qualify if:

  • \* Cognitive or behavioral problems that limit the ability of grandmothers and grandchildren to comprehend the intervention and complete study measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kent State University

Kent, Ohio, 44242, United States

RECRUITING

Related Publications (2)

  • Infurna FJ, Castro SA, Webster BA, Dolbin-MacNab ML, Smith GC, Crowley DM, Musil C. Does Social Intelligence Training Improve Daily Well-Being and Responsiveness to Daily Negative and Positive Events in Custodial Grandmothers? J Gerontol B Psychol Sci Soc Sci. 2024 Jul 1;79(7):gbae069. doi: 10.1093/geronb/gbae069.

  • Smith GC, Infurna FJ, Dolbin-MacNab M, Webster B, Castro S, Crowley DM, Musil C, Hu L, Hancock GR. A Randomized Clinical Trial of Online Social Intelligence Training With Custodial Grandmothers. Gerontologist. 2024 May 1;64(5):gnad079. doi: 10.1093/geront/gnad079.

MeSH Terms

Conditions

Social Skills

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Gregory C Smith, EdD

    Kent State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory C Smith, EdD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Longitudinal Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2017

First Posted

August 4, 2017

Study Start

May 31, 2018

Primary Completion

December 30, 2021

Study Completion

October 31, 2022

Last Updated

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations