School-based Treatment of Social Anxiety With Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorKlaus Ranta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
DOCT-SAD
BehavioralDevelopmentally 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.
SC
BehavioralStandard 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, routine professional working methods and procedures available to the SHWS professional delivering the intervention are used.
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD)Experimental treatment 1 intervention
Group B: Standard Counseling (SC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Self-reported social anxiety symptoms
Change in self-reported social anxiety symptoms assessed with the Social Phobia Inventory (SPIN)
Time frame
From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up point, and to 12-month follow-up point2
Diagnostic status of SAD
Change in the diagnostic status of SAD according DSM-5 criteria, assessed with ADIS-5 interview schedule
Time frame
From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up point, and to 12-month follow-up point3
Clinical severity of SAD symptoms
Change in the clinical severity of SAD symptoms assessed with the CSR scale of the ADIS-5 interview schedule
Time frame
From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-upSecondary outcomes
1
Self-reported safety behaviours associated with SAD
Change in self-reported safety behaviours associated with SAD assessed with the Subtle Avoidance Frequency Examination (SAFE)
Time frame
From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up2
Self-reported depressive symptoms
Change in self-reported depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9)
Time frame
From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up3
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)
Time frame
From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up4
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)
Time frame
From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-upOther outcomes
1
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
Time frame
From treatment startpoint to the end of the follow-up period (12 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Klaus Ranta
Lead sponsor
Tampere University
Sponsor institution
University of Helsinki
Collaborator
Finnish Institute for Health and Welfare
Collaborator
University of Eastern Finland
Collaborator
Source ClinicalTrials.gov