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Clinical Trial NCT06489639 (SBT-DOCT-SAD) for Social Anxiety Disorder, Social Anxiety, Adolescent - Emotional Problem is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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School-based Treatment of Social Anxiety With Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (SBT-DOCT-SAD) 156 Randomized Adolescent
Clinical Trial NCT06489639 (SBT-DOCT-SAD) is an interventional study for Social Anxiety Disorder, Social Anxiety, Adolescent - Emotional Problem that is recruiting. It started on March 20, 2023 with plans to enroll 156 participants. Led by Klaus Ranta, it is expected to complete by December 31, 2028. The latest data from ClinicalTrials.gov was last updated on July 8, 2024.
Brief 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-SA...
Show MoreDetailed Description
Aim:
The aim of this randomized controlled trial is to investigate whether a brief, 10-session intervention, the Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD; in Finnish Tosi minä -treeni) is more effective than standard counseling (SC) for alleviating symptoms of social anxiety and to treat Social Anxiety Disorder (SAD) among adolescents identified from School Health and Well-bei...
Show MoreOfficial Title
School-based Treatment of Social Anxiety: A Randomized and Controlled Study Using Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder
Conditions
Social Anxiety DisorderSocial AnxietyAdolescent - Emotional ProblemOther Study IDs
- SBT-DOCT-SAD
- R22123
NCT ID Number
Start Date (Actual)
2023-03-20
Last Update Posted
2024-07-08
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
156
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
social anxiety, adolescents, cognitive behavioural therapy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalDevelopmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD) Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD) is a ten-session, combined group/individual intervention program for treating social anxiety and social anxiety disorder in adolescents. It consists of four individual and six group sessions delivered during a ten-week period. The number of adolescents in each DOCT-SAD group varies between four and six. One or both parents attend two of...Show More | DOCT-SAD Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder is a 10-session, combined individual/group clinical intervention for treating social anxiety in adolescents. It consists of four individual and six group sessions during ten weeks. DOCT-SAD groups are formed for 4-6 adolescnts. One parent or both parents attend two of the individual sessions. |
Active ComparatorStandard Counseling (SC) Standard Counseling (SC) is an intervention consisting of counseling sessions delivered by a school health and welfare (SHWS) professional (i.e., school nurse, school social worker, or school psychologist) to support a student with social anxiety. The defined length of intervention is ten weeks. In SC, routine professional working methods and procedures available to the SHWS professional delivering the intervention a...Show More | SC Standard Counseling (SC) is a intervention consisting of counseling sessions delivered by a school health and welfare (SHWS) professional (i.e., school nurse, school social worker, or school psychologist) to support a student with social anxiety. The defined length of intervention is ten weeks, and number of sessions will be according to what is routinely agreed between the professional and the adolescent. In SC, rou...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
12 Years
Eligible Sexes
All
- age 13-17 years
- diagnosis of DSM-5 SAD (Social Anxiety Disorder)
- SAD is the primary mental health disorder
- motivation of the adolescent and parent to attend DOCT-SAD / SC as described in the study protocol
- good command of the Finnish language.
- intellectual deficit
- presence of primary autism spectrum disorder
- marked psychotic symptoms or psyhotic disorder
- severe eating disorder, depression or primary other anxiety disorder requiring acute treatment which need to be prioritized above treatment of social anxiety
- acute suicidality or suicide risk
- substance use or substance use disorder requiring child protection measures
- presence of contextual/environmental risk factors in the participants surroundings which require child protection measures
Klaus Ranta- 🎓University...
Study Responsible Party
Klaus Ranta, Sponsor-Investigator, Associate Professor, Tampere University
Study Central Contact
Contact: Klaus Ranta, MD, PhD, +358 504418286, [email protected]
Contact: Siiri Lampela, MSc, +358 505940399, [email protected]
1 Study Locations in 1 Countries
Pirkanmaa
Tampere University, Tampere, Pirkanmaa, 33014, Finland
Klaus Ranta, MD, PhD, Contact, +358 504418286, [email protected]
Siiri Lampela, MSc, Contact, +358 505940399, [email protected]
Recruiting