Clinical trial NCT04782102: SOPHIE: Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents
Official title: SOPHIE: a Randomised Controlled Trial to Investigate the Efficacy of Online-intervention for Prevention and Treatment of Social Anxiety in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Social Anxiety Disorder
Keywords: Prevention
Intervention
Adolescents
Youths
Online-Intervention
Internet-Intervention
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 128
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008)
timeFrame: Baseline assessment compared to assessment at post-intervention (2 months after baseline)
Secondary outcomes:
measure: Current and past mental disorder assessed by the structured diagnostic interview for mental disorders of childhood and adolescence (Kinder-DIPS; Schneider et al., 2017)
timeFrame: Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention);
measure: Change in global functioning assessed by the GF Social (Cornblatt et al., 2007)
timeFrame: Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention)
measure: Change in global functioning assessed by the GF Role Scale (Cornblatt et al., 2007)
timeFrame: Assessed at baseline, at post-intervention (2 months after baseline) and follow-up (5 months after intervention)
measure: Utilisation of help assessed by the Client Sociodemographic and Service Receipt Inventory (CSSRI-EU; Chisholm et al., 2000; Roick et al., 2001)
timeFrame: Assessed at post-intervention (2 months after baseline) and follow-up (5 months after baseline)
measure: Change of fear of negative evaluation and avoidance assessed by the Social Anxiety Scale for Adolescents (SAS-A; La Greca & Lopez,1998)
timeFrame: 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)
measure: Change of generalized anxiety symptoms assessed by the Generalized Anxiety Disorder 7 (GAD-7; Löwe et al., 2008) questionnaire
timeFrame: 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)
measure: Change in depressive symptoms assessed by the Patient Health Questionnaire-9 for Adolescents (PHQ-A; Johnson et al., 2002)
timeFrame: 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)
measure: Change in health-related quality of life assessed by the KIDSCREEN-10 (Ravens-Sieberer et al., 2010)
timeFrame: 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)
measure: Change in self-esteem assessed by the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965)
timeFrame: 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)
measure: Change in social anxiety assessed by the Social Phobia Inventory (SPIN; Connor et al., German Version: Sosic et al., 2008)
timeFrame: 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)
Other outcomes:
measure: Adherence to the Online-Intervention
timeFrame: During the eight-week online-intervention
measure: Adherence to the Online-Intervention
timeFrame: During the eight-week online-intervention
measure: Adherence to the Online-Intervention
timeFrame: During the eight-week online-intervention
measure: Adherence to the Online-Intervention
timeFrame: During the eight-week online-intervention
measure: Negative effects of the online-intervention
timeFrame: Assessed at post-intervention (2 months after baseline)
measure: Satisfaction with the online-intervention assessed by the Zufriedenheit mit der Intervention (ZUF-8; Schmidt et al., 1989) questionnaire
timeFrame: Assessed at post-intervention (2 months after baseline)
measure: Therapeutic alliance assessed by the Working Alliance Inventory for Guided Internet Interventions (WAI-I; Gómez Penedo et al., 2020)
timeFrame: Assessed 2, 4, 6, and 8 weeks after baseline (during the online-intervention every two weeks)
measure: Motivation of adolescent for the online-intervention assessed with the Motivation for Youth's Treatment Scale (MYTS; Breda & Riemer, 2012) youth version
timeFrame: Assessed at baseline and every two week during the eight week online-intervention (after 2, 4, 6, and 8 weeks)
measure: Motivation of parent / guardian for the online-intervention assessed with the Motivation for Youth's Treatment Scale (MYTS; Breda & Riemer, 2012) parent version
timeFrame: Baseline, mid-intervention(after 1 Month), and at post-intervention (after 2 months)
measure: Adolescents' expectation of the online-intervention assessed with the Credibility/Expectancies Questionnaire (CEQ; Devilly & Borkovec, 2000) youth version
timeFrame: Assessed at baseline
measure: Parents' / Guardians' expectation of the online-intervention assessed with the Credibility/Expectancies Questionnaire (CEQ; Devilly & Borkovec, 2000) parent version
timeFrame: Assessed at baseline
measure: Ecological Momentary Assessment (EMA)
timeFrame: 3 times a day during the eight week online-intervention, and three times a day for the two succeeding weeks after the follow-up assessment (5 months after baseline).
measure: Change in parents' / guardians' assessment of their children's social anxieties assessed by the Elternfragebogen zu sozialen Ängsten im Kindes- und Jugendalter (ESAK, van Gemmeren et al., 2008)
timeFrame: 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)
measure: Interview with adolescents in the intervention group on satisfaction with the online intervention
timeFrame: Assessed at post-intervention (2 months after randomization)
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Stefanie J Schmidt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Thomas Berger, Prof. Dr.
role: STUDY_CHAIR
References: