N/A N=90 Randomized Single-blind Treatment

Treatment of Social Anxiety Disorder and Selective Mutism

Social Anxiety Disorder · Selective Mutism

Bottom Line

View on ClinicalTrials.gov: NCT02554929 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) — -1.26; -1.65; -1.51; -1.24 units on a scale — p=0.002

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Taming Sneaky Fears (Behavioral); Parent Psycho-education and Child Socialization (Behavioral)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: The Hospital for Sick Children
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)	-1.12; -1.46; -1.49; -0.66	—
SECONDARY Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)	-1.12; -1.46; -1.49; -0.66	—
SECONDARY Change in Children's Global Assessment Scale (CGAS)	15.2; 14.3	0.002 sig
SECONDARY Change in Children's Global Assessment Scale (CGAS)	15.2; 14.3	0.002 sig
SECONDARY Selective Mutism Questionnaire (SMQ)	20.0; 19.2; 26.2; 23.4; 30.2; 27.6	—
SECONDARY The Preschool Anxiety Scale - Parent Report	36.7; 39.6; 32.3; 35.8; 26.5; 31.4	—

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.

Eligibility Criteria

Inclusion Criteria

4 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 .
Presence of other anxiety disorders/symptoms is not an exclusion criterion as long as the main concern (primary diagnosis) is SAD and/or SM.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02554929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.