School-based Treatment of Social Anxiety With Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder
NCT Number: NCT06489639
Acronym: SBT-DOCT-SAD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Social Anxiety Disorder|Social Anxiety|Adolescent - Emotional Problem
Interventions: BEHAVIORAL: DOCT-SAD|BEHAVIORAL: SC
Sponsor: Klaus Ranta
Collaborators: University of Helsinki|Finnish Institute for Health and Welfare|University of Eastern Finland
Sex: ALL
Age: CHILD
Enrollment: 156
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-20
Completion Date: 2028-12-31
Locations: Tampere University, Tampere, Pirkanmaa, 33014, Finland

Summary:
The goal of this randomized controlled trial is to find out whether the brief, 10-session Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD) is more effective than standard counseling (SC) to treat Social Anxiety Disorder (SAD) among 12 to 17-year-old adolescents with SAD.

Potential participants for the study are identified from school health and well-being services (SHWS). The DOCT-SAD is delivered by method-trained school psychologists working in the SHWS. SC will be provided by non-method-trained SHWS professionals (i.e. school nurses, social workers or school psychologists) according to their routine counselling practice.

The main research questions of the study are:

1. Is DOCT-SAD more effective than SC for alleviating symptoms of social anxiety?
2. Is DOCT-SAD more effective than SC to produce diagnostic remission from primary SAD and alleviating symptom severity associated with SAD?
3. Is DOCT-SAD more effective than SC for alleviating co-occurring depressive symptoms, interference in daily functioning due to worry or fears, and for increasing general well-being, positive mental health, and for improving the quality of life among adolescents with SAD?

Researchers will compare DOCT-SAD with SC to see if DOCT-SAD is effective in the treatment of SAD in adolescents.

Participants will:

* be treated either with DOCT-SAD or SC for 10 weeks.
* be followed up and assessed clinically at six-month and twelve-month follow-up points.

Primary Outcome Measures: Self-reported social anxiety symptoms, Change in self-reported social anxiety symptoms assessed with the Social Phobia Inventory (SPIN), From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up point, and to 12-month follow-up point|Diagnostic status of SAD, Change in the diagnostic status of SAD according DSM-5 criteria, assessed with ADIS-5 interview schedule, From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up point, and to 12-month follow-up point|Clinical severity of SAD symptoms, Change in the clinical severity of SAD symptoms assessed with the CSR scale of the ADIS-5 interview schedule, From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up
Secondary Outcome Measures: Self-reported safety behaviours associated with SAD, Change in self-reported safety behaviours associated with SAD assessed with the Subtle Avoidance Frequency Examination (SAFE), From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up|Self-reported depressive symptoms, Change in self-reported depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9), From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up|Self-reported life interference due to fears and worries, Change in self-reported life inteference due to fears and worries assessed with the Child Anxiety Life Interference Scale (CALIS-C), From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up|Parent-reported life interference due to adolescent's fears and worries, Change in parent-reported life inteference due to adolescent's fears and worries assessed with the Child Anxiety Life Interference Scale for Parents (CALIS-P), From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up|Self-reported general well-being, Change in self-reported general well-being assessed with the Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE), From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up|Self-reported positive mental health, Change in self-reported positive mental health assessed with the Short version of the Warwick-Edinburgh Mental Well-being Scale (SWEMWBS), From treatment startpoint to the end of the follow-up period (12 months)|Self-reported quality of life, Change in self-reported quality of life assessed with the World Health Organization Quality of Life -BREF (WHOQOL-BREF), From treatment startpoint to the end of the follow-up period (12 months)
Other Outcome Measures: Use of healthcare and consulting services during prior six months, Change in adolescent's use of healthcare and consulting services during prior six months reported by the adolescent and parents, assessed with a structured survey form, From treatment startpoint to the end of the follow-up period (12 months)