Effectiveness of a Psychological Intervention to Reduce Social Isolation and Promote Social Connectedness in Young Adults

N/ANot Yet RecruitingNCT07820020

Korea University80 enrolled

Overview

The purpose of this randomized controlled trial is to evaluate the effectiveness of a psychological intervention aimed at reducing social isolation and promoting social connectedness among young adults. Specifically, the study investigates the impact of an 8-week, digitally assisted face-to-face group social skills training program on individuals aged 19 to 34 who experience difficulties in interpersonal relationships and social isolation. Participants will be randomly assigned to either the active intervention group or a waitlist control group. The study aims to determine whether this structured psychosocial intervention improves interpersonal competence and social performance, reduces social isolation, and improves other psychosocial variables. Outcomes will be evaluated at three time points-pre-intervention, post-intervention, and a 1-month follow-up-utilizing a combination of self-report questionnaires and performance-based role-play assessments.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Social Isolation Loneliness Social Skills

Interventions

Digital-Assisted Group Social Skills TrainingBEHAVIORAL

Participants assigned to the active intervention arm receive an 8-week, face-to-face group social skills training program, which involves weekly 120-minute sessions supplemented by a web-based digital platform designed to promote between-session practice and skill generalization.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 34 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 19 to 34 years * South Korean nationality * Interpersonal Competence Questionnaire, 15-item short form (ICQ-15): mean score of 2.87 or lower * Meets either (a) or (b) below: * (a) Lubben Social Network Scale-6 (LSNS-6) total score of less than 12, AND short-form UCLA Loneliness Scale-8 total score of 17 or higher * (b) Korea University Social Isolation Scale (KUSIS) total score of 9 or higher * Confirmation on a non-face-to-face screening interview that the participant's primary difficulty involves interpersonal problems stemming from a lack of social knowledge and skills Exclusion Criteria: * Psychiatric or neurological hospitalization within the past 6 months * Current or past diagnosis of a severe neurological disorder * Cognitive impairment severe enough to hinder the basic communication required for program participation * Suicide attempt within the past 6 months * Severe suicide risk identified during the assessment * History of psychotic symptoms or manic episodes * Severe psychiatric condition or major medical abnormality that would complicate participation * Unable or unwilling to follow the research team's instructions during the application process * Currently participating in individual or group psychotherapy that provides training in other social skills * Participation within the past 5 years in a study on social isolation conducted by an investigator of the present research team, which raises concern for a confounding effect on the study results

Outcomes

Primary Outcomes

Korean Version of the Interpersonal Competence Questionnaire (K-ICQ)

The Korean Version of the Interpersonal Competence Questionnaire (K-ICQ) is a 31-item self-report measure of interpersonal competence. Each item is rated on a 5-point Likert scale from 1 (poor) to 5 (extremely good). The total score sums all items and ranges from 31 to 155. Higher scores indicate greater interpersonal competence, which is a better outcome.

Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)

Social Skills Knowledge Test

The Social Skills Knowledge Test is an investigator-developed knowledge test created to objectively measure acquisition of the social skills content taught in the intervention. It consists of 21 items (multiple-choice and true/false) covering seven domains that correspond to the session curriculum: relationship formation skills, conversation skills I, conversation skills II, assertion skills, conflict management skills, dating skills, and workplace skills, with 3 items per domain. Each item has an unambiguously correct answer and is scored 1 (correct) or 0 (incorrect). The total score is the sum of correct responses and ranges from 0 to 21. Higher scores indicate greater knowledge of social skills, which is a better outcome.

Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)

LINK Skill-Specific Behavior Coding System (LINK-BSC) performance score

The LINK Skill-Specific Behavior Coding System (LINK-BSC) is an investigator-developed observational coding system for the social skills explicitly taught in the intervention. Two structured role-play scenes are coded: an interaction with an unfamiliar peer (9 indicators) and a face-to-face assertion and conflict-management task (9 indicators), 18 indicators in total. Each indicator is coded as 1 (displayed) or 0 (not displayed). The occurrence score is the number of indicators displayed divided by the number of applicable indicators, expressed as a percentage from 0 to 100. Higher scores indicate a broader repertoire of the trained skills, which is a better outcome.

Time frame: Baseline and post-intervention (at 8 weeks)

LINK Skill-Specific Behavior Coding System (LINK-BSC) proficiency score

The LINK Skill-Specific Behavior Coding System (LINK-BSC) is an investigator-developed observational coding system for the social skills explicitly taught in the intervention. Two structured role-play scenes are coded: an interaction with an unfamiliar peer (9 indicators) and a face-to-face assertion and conflict-management task (9 indicators), 18 indicators in total. Each indicator is first coded for occurrence (1 = displayed, 0 = not displayed) and then for proficiency on a 3-point scale from 0 to 2. The proficiency score is the sum of the proficiency ratings across all 18 indicators divided by twice the number of applicable indicators, expressed as a percentage from 0 to 100. Indicators for which no opportunity was provided are excluded from the denominator. Higher scores indicate more proficient use of the trained skills, which is a better outcome.

Time frame: Baseline and post-intervention (at 8 weeks)

Secondary Outcomes

Social Performance Rating Scale (SPRS)

The Social Performance Rating Scale (SPRS) is an observer-rated measure of the molecular verbal and nonverbal quality of social performance during structured role-plays. Two scored role-play scenes are administered - an interaction with an unfamiliar peer (approximately 3 minutes) and a face-to-face assertion and conflict-management task (approximately 4 minutes) - preceded by an unscored 1-minute practice scene. In each scored scene, trained raters blinded to group allocation and assessment time point rate five domains: gaze, vocal quality, length of speech, discomfort, and conversational flow. Each domain is rated on a 5-point scale from 1 (very poor) to 5 (very good), with the discomfort item reverse-scored so that higher values indicate less discomfort. Each scene score ranges from 5 to 25, and the total score across the two scored scenes ranges from 10 to 50. Higher scores indicate more appropriate and positive social performance, which is a better outcome.

Time frame: Baseline and post-intervention (at 8 weeks)

Korea University Social Isolation Scale (KUSIS)

The Korea University Social Isolation Scale (KUSIS) is a 9-item self-report measure of social isolation risk. Respondents rate their state over the past month, excluding people they currently live with. Each item is rated on a 4-point scale from 0 (never) to 3 (very much). The total score sums all items and ranges from 0 to 27, with a cut-off of 9 or higher indicating risk of social isolation. Higher scores indicate greater social isolation, which is a worse outcome.

Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)

Lubben Social Network Scale-6 (LSNS-6)

The Lubben Social Network Scale-6 (LSNS-6) is a 6-item self-report measure of social network size and engagement; three items concern family and relatives, and three concern friends and other acquaintances. Each item is rated on a 6-point scale from 0 (none) to 5 (nine or more people). The total score sums all items and ranges from 0 to 30. Higher scores indicate a larger and more engaged social network, which is a better outcome.

Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)

Short-form UCLA Loneliness Scale-8

The short-form UCLA Loneliness Scale-8 (ULS-8) is an 8-item self-report measure of loneliness abbreviated from the 20-item UCLA Loneliness Scale. Each item is rated on a 4-point scale from 1 (never) to 4 (always); two positively worded items are reverse-scored. The total score is the sum of all items and ranges from 8 to 32. Higher scores indicate greater loneliness, which is a worse outcome.

Central Contacts

Jaehee Jung

CONTACT

821073177521 emqhfkwogml13@gmail.com

Data from ClinicalTrials.gov

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Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)

Patient Health Questionnaire-9 (PHQ-9)

The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depressive symptoms over the preceding two weeks, based on the DSM-IV diagnostic criteria for major depressive disorder. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of all items and ranges from 0 to 27. Higher scores indicate more severe depressive symptoms, which is a worse outcome.

Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)

Generalized Anxiety Disorder-7 (GAD-7)

The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of the core symptoms of generalized anxiety disorder over the preceding two weeks. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of all items and ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms, which is a worse outcome.

Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)

Korean version of the Social Interaction Anxiety Scale-Social Phobia Scale Short Form (K-SIAS-SPS-SF)

The Korean version of the Social Interaction Anxiety Scale-Social Phobia Scale Short Form (K-SIAS-SPS-SF) is a single 14-item self-report measure of social anxiety. Its items were derived by exploratory factor analysis of the pooled 40-item set of the Social Interaction Anxiety Scale and the Social Phobia Scale, and the resulting instrument is administered and scored as one scale comprising three correlated factors: social interaction anxiety (5 items), fear of overt evaluation (6 items), and fear of attracting attention (3 items). Each item is rated on a 5-point scale from 0 (not at all characteristic of me) to 4 (extremely characteristic of me). A single total score is obtained by summing all 14 items and ranges from 0 to 56, with a total score of 22 or higher indicating probable social anxiety disorder. Higher scores indicate greater social anxiety, which is a worse outcome.

Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)

Mental Health Continuum-Short Form (MHC-SF)

The Mental Health Continuum-Short Form (MHC-SF) is a 14-item self-report measure of positive mental health over the past month, comprising three subscales: emotional well-being (3 items), social well-being (5 items), and psychological well-being (6 items). Each item is rated on a 6-point frequency scale from 0 (never) to 5 (every day). The total score sums all items and ranges from 0 to 70. Higher scores indicate greater well-being, which is a better outcome.

Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)

Multidimensional Scale of Perceived Social Support (MSPSS)

The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report measure of perceived social support from three sources: significant other, family, and friends, with 4 items per source. Each item is rated on a 7-point Likert scale from 1 (very strongly disagree) to 7 (very strongly agree). The total score sums all items and ranges from 12 to 84. Higher scores indicate greater perceived social support, which is a better outcome.

Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)

Broad Autism Phenotype Questionnaire Short Form (BAPQ-SF)

The Broad Autism Phenotype Questionnaire Short Form (BAPQ-SF) is a 14-item self-report measure that assesses core features of the autism spectrum as a continuous dimension in the general population. Each item is rated on a 6-point frequency scale from 1 (very rarely) to 6 (very often), and positively worded items are reverse-scored so that higher values reflect more pronounced traits. The total score sums all items and ranges from 14 to 84. Higher scores indicate more pronounced broad autism phenotype traits, which is a worse outcome.

Time frame: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)