SOPHIE: Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents

Study Overview
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Brief Summary
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This study's aim is to investigate the efficacy of the online-intervention SOPHIE. SOPHIE is an online-intervention for adolescents with social anxiety. In Switzerland, Germany, Austria and Liechtenstein, about one in 15 adolescents suffers from social anxiety. The SOPHIE intervention aims to help these adolescents to better understand and cope with their social anxiety symptoms and to feel more comfortable in social situations. The investigators intend to include 248 adolescents in the study. Stratified by subclinical and clinical level of social anxiety, participants will be randomly assigned to the SOPHIE group or the control group receiving care-as-usual. Both groups will complete online questionnaires and will be interviewed via telephone several times during the study. This allows to compare the two groups regarding their efficacy of the SOPHIE programme in terms of changes in social anxiety over time.

Official Title
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SOPHIE: a Randomised Controlled Trial to Investigate the Efficacy of Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents

Conditions
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Social Anxiety, Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: SOPHIE Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 11;00 (11 years and 0 months) and 17;11 (17 years and 11 months) Good written and spoken German language skills Access to an Internet connection and a device to use the intervention (tablet, smartphone, PC) and to collect the EMA data (smartphone) Subclinical values on the SPIN (value: 16-23; Loscalzo et al., 2018) or criteria for social anxiety disorder according to Kinder-DIPS (Schneider et al., 2017) Written consent of the adolescent (if at least 14 years old) or the parents or guardian (if adolescent under 14 years old) and assent of adolescent under 14 years old Exclusion Criteria: Known diagnosis of autism spectrum disorder Current suicidal ideation (collected via PHQ-A Item 9) Lack of knowledge of the German language in spoken and written form Past diagnosis of social anxiety according to the DSM-5 criteria assessed by the Kinder-DIPS (Schneider et al., 2017) in participants with current subclinical anxiety

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOPHIE Intervention<br>SOPHIE is an online-intervention aiming to reduce social anxiety in adolescents. SOPHIE has 8 modules, one module per week, which lasts about 60 minutes. SOPHIE includes elements of evidence-based psychotherapeutic interventions to reduce social anxiety and of an existing online-intervention for adults with social anxiety adopted to the needs of adolescents. The intervention consists of psychoeducation (how social anxieties arise), application examples (e.g. setting up a personal anxiety cycle or anxiety pyramid, imagination exercise: journey to a safe place), and contains weekly tasks for which regular repetition in everyday life is important (e.g. progressive muscle relaxation, observing anxiety in everyday life, exposures in various situations). At the end of each module, a short quiz allows participants to recall and consolidate what they have learned. The content is presented in video inputs, short explanatory texts, application tasks and quizzes. | Behavioral: SOPHIE Intervention<br>* SOPHIE is an online-intervention aiming to reduce social anxiety in adolescents. SOPHIE has 8 modules, one module per week, which lasts about 60 minutes. SOPHIE includes elements of evidence-based psychotherapeutic interventions to reduce social anxiety and of an existing online-intervention for adults with social anxiety adopted to the needs of adolescents. The intervention consists of psychoeducation (how social anxieties arise), application examples (e.g. setting up a personal anxiety cycle or anxiety pyramid, imagination exercise: journey to a safe place), and contains weekly tasks for which regular repetition in everyday life is important (e.g. progressive muscle relaxation, observing anxiety in everyday life, exposures in various situations). At the end of each module, a short quiz allows participants to recall and consolidate what they have learned. The content is presented in video inputs, short explanatory texts, application tasks and quizzes.<br>|
| No Intervention: Care-as-usual<br>Care-As-Usual: all other kinds of interventions are allowed and will be recorded using the Client Sociodemographic and Service Receipt Inventory (Chisholm et al., 2000; Roick et al., 2001) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008) | Measure of social anxiety, total score ranging from 0 - 68 (representing the sum of each of the 17 individual items). Lower scores represent less social anxiety and a more favourable outcome. | Baseline assessment compared to assessment at post-intervention (2 months after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current and past mental disorder assessed by the structured diagnostic interview for mental disorders of childhood and adolescence (Kinder-DIPS; Schneider et al., 2017) | At Baseline, the entire Kinder-DIPS will be assessed. At post and follow-up, only the sections for social anxiety and comorbid diagnoses met at baseline are assessed. | Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention); | 
| Change in global functioning assessed by the GF Social (Cornblatt et al., 2007) | Structured interview assessing the level of functioning in social areas of life (friends & family) ranging from 1 to 10, higher scores indicate a better level of functioning | Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention) | 
| Change in global functioning assessed by the GF Role Scale (Cornblatt et al., 2007) | Structured interview assessing the level of functioning in school / work ranging from 1 to 10, higher scores indicate a better level of functioning | Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention) | 
| Utilisation of help assessed by the Client Sociodemographic and Service Receipt Inventory (CSSRI-EU; Chisholm et al., 2000; Roick et al., 2001) | Structured interview assessing the additional use of psychological, medical and other formal and informal services and sources of help (e.g. at school, friends) | Assessed at post-intervention (2 months after baseline) and follow-up (5 months after baseline) | 
| Change of fear of negative evaluation and avoidance assessed by the Social Anxiety Scale for Adolescents (SAS-A; La Greca & Lopez,1998) | Total score ranging from 18 - 90 (representing the sum of each of the 18 individual items). Lower scores represent less fear of negative evaluation and avoidance and a more favourable outcome. | Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline) | 
| Change of generalized anxiety symptoms assessed by the Generalized Anxiety Disorder 7 (GAD-7; Löwe et al., 2008) questionnaire | Total score ranging from 7 - 35 (representing the sum of each of the 7 individual items). Lower scores represent less anxiety and a more favourable outcome. | Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline) | 
| Change in depressive symptoms assessed by the Patient Health Questionnaire-9 for Adolescents (PHQ-A; Johnson et al., 2002) | Total score ranging from 0 - 27 (representing the sum of each of the 9 individual items). Lower scores represent less depressive symptoms and a more favourable outcome. | Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline) | 
| Change in health-related quality of life assessed by the KIDSCREEN-10 (Ravens-Sieberer et al., 2010) | Total score ranging from 11 - 55 (representing the sum of each of the 11 individual items). Higher scores represent a higher quality of life and a more favourable outcome. | Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline) | 
| Change in self-esteem assessed by the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965) | Total score ranging from 0 - 30 (representing the sum of each of the 10 individual items). Higher scores represent a higher self-esteem and a more favourable outcome. | Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline) | 
| Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008) | Measure of social anxiety, total score ranging from 0 - 68 (representing the sum of each of the 17 individual items). Lower scores represent less social anxiety and a more favourable outcome. | Assessed at baseline, at mid-treatment (1 month after baseline), at post-intervention (2 months after baseline), and at follow-up (5 months after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Intervention, Adolescents, Youths, Online-Intervention, Internet-Intervention