Treatment of Social Anxiety Disorder and Selective Mutism

NCT02554929 | Completed Results

• 1 other identifier: 1000050447
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the efficacy of a brief, 11-week, manualized Taming Sneaky Fears for Social Anxiety Disorder (SAD) and/or Selective Mutism (SM) child and parent group Cognitive Behavioural Therapy (CBT) treatment protocol. Children 4 to 7 years old (n = 88) meeting criteria for SAD and/or SM, and their parents are recruited from the Psychiatry Outpatient Program and participants will be randomized to either the Taming Sneaky Fears group or a parent psycho-education and child socialization group. Trained clinicians blinded to all measures and treatment assignment will administer pre, post and 6-month follow-up outcome measures. Investigators assess within-the-child and within-the-parent/environment factors that predict treatment outcomes.

Conditions

Social Anxiety Disorder; Selective Mutism

Keywords

Social Anxiety Disorder; Selective Mutism; CBT; preschool anxiety disorders

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)

  The Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV): Parent Version (ADIS-P) is a semi-structured, clinician-administered, interview of parents used to diagnose anxiety and other related disorders in children and adolescents. Parents were asked to rate for interference or impairment using a 9-point scale ranging from 0 to 8, with 0 being not impaired or not interfering and 8 being significant impairment or interference. A final Clinician Severity Rating (CSR) was then established using the same scale, with a CSR of 4 (moderate degree of impairment) or greater required to establish a diagnosis.

  Change from Baseline in CSR of SAD & SM at 6 months after treatment ends. Treatment groups run for 11 weeks.

Secondary Outcomes (5)

• Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)

  Change from Baseline in CSR within 4 weeks of treatment end. Treatment groups run for 11 weeks.

• Change in Children's Global Assessment Scale (CGAS)

  Change from Baseline on the CGAS within 4 weeks of treatment end. Treatment groups run for 11 weeks.

• Change in Children's Global Assessment Scale (CGAS)

  Change from Baseline on the CGAS at 6 months post-treatment end. Treatment groups run for 11 weeks.

• Selective Mutism Questionnaire (SMQ)

  The SMQ was completed by parents at all 3 time-points: 1) Pre-treatment (baseline), 2) Post-treatment, and 3) 6-month follow-up (from baseline date).

• The Preschool Anxiety Scale - Parent Report

  The PAS-P was completed by parents at all 3 time-points: 1) Pre-treatment (baseline), 2) Post-treatment, and 3) 6-month follow-up (from baseline date).

Study Arms (2)

Taming Sneaky Fears Group

EXPERIMENTAL

An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral strategies specifically developed for children 4 to 7 years of age with social anxiety disorder and/or selective mutism. Parent and child groups run separately but concurrently.

Behavioral: Taming Sneaky Fears

Parent Psychoeducation and Child Socialization Group

ACTIVE COMPARATOR

An 11 week (introduction plus 10 week) manualized treatment protocol focusing on parent psychoeducation and child socialization in children 4 to 7 years of age with social anxiety disorder and/or selective mutism. Parent and child groups run separately but concurrently.

Behavioral: Parent Psycho-education and Child Socialization

Interventions

Taming Sneaky Fears BEHAVIORAL

Parents receive coping strategies based on CBT in parent group and children receive coping strategies based on CBT in child group.

Also known as: Cognitive Behavioral Therapy (CBT)

Taming Sneaky Fears Group

Parent Psycho-education and Child Socialization BEHAVIORAL

Parents receive psycho-education in parent group and children receive socialization skills in child group.

Also known as: Psycho-education and Socialization

Parent Psychoeducation and Child Socialization Group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 7 year old children who meet diagnostic criteria for a primary diagnosis of Selective Mutism (SM) and/or Social Anxiety Disorder (SAD) through a clinical and semi-structured diagnostic interview .

You may not qualify if:

• Presence of autism spectrum disorder, brain injury, or significant developmental delays (based on medical history and clinical assessment).
• Children and parents not fluent in English.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (4)

• Albano, A. M., & Silverman, W. K. (1996). Anxiety Disorders Interview Schedule for DSM-IV-Child Version: Clinician Manual. Psychological Corporation.

  BACKGROUND

• Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, Aluwahlia S. A children's global assessment scale (CGAS). Arch Gen Psychiatry. 1983 Nov;40(11):1228-31. doi: 10.1001/archpsyc.1983.01790100074010.

  PMID: 6639293 BACKGROUND

• Bergman RL, Keller ML, Piacentini J, Bergman AJ. The development and psychometric properties of the selective mutism questionnaire. J Clin Child Adolesc Psychol. 2008 Apr;37(2):456-64. doi: 10.1080/15374410801955805.

  PMID: 18470781 BACKGROUND

• Spence, S. H., & Rapee, R. (1999). Preschool anxiety scale (parent report). Brisbane, Australia: University of Queensland.

  BACKGROUND

MeSH Terms

Conditions

Phobia, Social; Mutism

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Suneeta Monga
• Organization: The Hospital for Sick Children

suneeta.monga@sickkids.ca

416-813-8954

Study Officials

• Suneeta Monga, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Psychiatry Ambulatory Services

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 18, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 29, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-10

Locations

CA (1)