School-based Treatment of Social Anxiety With Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder

NCT06489639 | Recruiting DMC

• 1 other identifier: R22123
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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-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:

• 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.

Conditions

Social Anxiety Disorder; Social Anxiety; Adolescent - Emotional Problem

Keywords

social anxiety, adolescents, cognitive behavioural therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Self-reported safety behaviours associated with SAD

  From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up

• Self-reported depressive symptoms

  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

  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

  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

  From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up

Other Outcomes (1)

• Use of healthcare and consulting services during prior six months

  From treatment startpoint to the end of the follow-up period (12 months)

Study Arms (2)

Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD)

EXPERIMENTAL

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 the individual DOCT-SAD sessions.

Behavioral: DOCT-SAD

Standard Counseling (SC)

ACTIVE COMPARATOR

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 are used.

Behavioral: SC

Interventions

DOCT-SAD BEHAVIORAL

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.

Also known as: Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder

Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD)

SC BEHAVIORAL

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, routine professional working methods and procedures available to the SHWS professional delivering the intervention are used.

Also known as: Standard Counseling

Standard Counseling (SC)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Klaus Ranta: lead
• University of Helsinki: collaborator
• Finnish Institute for Health and Welfare: collaborator
• University of Eastern Finland: collaborator

Study Sites (1)

Tampere University

Tampere, Pirkanmaa, 33014, Finland

RECRUITING

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Klaus Ranta, MD, PhD

  Tampere University

  STUDY DIRECTOR

Central Study Contacts

Klaus Ranta, MD, PhD

CONTACT

+358 504418286; klaus.ranta@tuni.fi

Siiri Lampela, MSc

CONTACT

+358 505940399; siiri.lampela@tuni.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: March 20, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 8, 2024

Record last verified: 2024-06

Locations

FI (1)