- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07820020
Effectiveness of a Psychological Intervention to Reduce Social Isolation and Promote Social Connectedness in Young Adults
13 de septiembre de 2026 actualizado por: KEE-HONG CHOI, Korea University
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
80
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jaehee Jung
- Número de teléfono: 821073177521
- Correo electrónico: emqhfkwogml13@gmail.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control de lista de espera
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Experimental: Digital-Assisted Group Social Skills Training
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Korean Version of the Interpersonal Competence Questionnaire (K-ICQ)
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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Social Skills Knowledge Test
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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LINK Skill-Specific Behavior Coding System (LINK-BSC) performance score
Periodo de tiempo: Baseline and post-intervention (at 8 weeks)
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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.
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Baseline and post-intervention (at 8 weeks)
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LINK Skill-Specific Behavior Coding System (LINK-BSC) proficiency score
Periodo de tiempo: Baseline and post-intervention (at 8 weeks)
|
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.
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Baseline and post-intervention (at 8 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Social Performance Rating Scale (SPRS)
Periodo de tiempo: Baseline and post-intervention (at 8 weeks)
|
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.
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Baseline and post-intervention (at 8 weeks)
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Korea University Social Isolation Scale (KUSIS)
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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Lubben Social Network Scale-6 (LSNS-6)
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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Short-form UCLA Loneliness Scale-8
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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Generalized Anxiety Disorder-7 (GAD-7)
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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Korean version of the Social Interaction Anxiety Scale-Social Phobia Scale Short Form (K-SIAS-SPS-SF)
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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Mental Health Continuum-Short Form (MHC-SF)
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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Multidimensional Scale of Perceived Social Support (MSPSS)
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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Broad Autism Phenotype Questionnaire Short Form (BAPQ-SF)
Periodo de tiempo: Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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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.
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Baseline, immediately post-intervention (at 8 weeks), and 1-month follow-up (at 12 weeks)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de septiembre de 2026
Finalización primaria (Estimado)
30 de octubre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
7 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de septiembre de 2026
Publicado por primera vez (Actual)
15 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KUIRB-2026-0388
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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