Clinical Trial: Treatment of Social Anxiety Disorder and Selective Mutism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of a Group Cognitive Behavioral Therapy Program in the Treatment of Young Children With Social Anxiety Disorder and/or Selective Mutism: A Randomized Controlled T

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.

Detailed Summary:

This study utilizes a repeated measures, longitudinal, randomized controlled trial design to compare the efficacy of two interventions in the treatment of children aged 4 to 7 years with SM and/or SAD. Participants are randomized into either the:

1. Taming Sneaky Fears for SAD and/or SM parent and child group CBT treatment, or
2. the Parent Psycho-education and Child Socialization comparison program.

Both programs run for 10 consecutive weeks (plus one additional introduction week). To control for the nonspecific factors associated with treatment, such as the support, attention and expectation of improvement, parents and children in both treatment protocols receive comparable levels of attention from therapists (i.e., same duration of group sessions and total number of sessions with a therapist) and comparable opportunities for socialization (e.g., for the children: invitation to discuss how the previous week went, snack time, story time; for the parents: discussion of specific topics at each session). However, parents and children in the comparison group are not taught CBT strategies.

Sponsor: The Hospital for Sick Children

Current Primary Outcome: Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) [ Time Frame: Change from Baseline in CSR of SAD & SM at 6 months after treatment ends. Treatment groups run for 11 weeks. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) [ Time Frame: Change from Baseline in CSR within 4 weeks of treatment end. Treatment groups run for 11 weeks. ]
  The Clinical Severity Ratings range from 0 (no symptoms) to 8 (severe symptoms) with a rating of 4 indicating "meets diagnostic level"
• Change in Children's Global Assessment Scale (CGAS) which ranges from 1 (needs constant supervision to 100 (superior functioning) [ Time Frame: Change from Baseline on the CGAS within 4 weeks of treatment end. Treatment groups run for 11 weeks. ]
  The CGAS measures level of general functioning on a 100 point scale - 1 (needs constant supervision) to 100 (superior functioning). Every 10 points global functioning moves to the next category.
• Change in Children's Global Assessment Scale (CGAS) [ Time Frame: Change from Baseline on the CGAS at 6 months post-treatment end. Treatment groups run for 11 weeks. ]
  The CGAS measures level of general functioning on a 100 point scale - 1 (needs constant supervision) to 100 (superior functioning). Every 10 points global functioning moves to the next category.
• Selective Mutism Questionnaire (SMQ) [ Time Frame: Change from Baseline on the SMQ within 4 weeks of treatment completion and at 6 months post-treatment. Treatment groups run for 11 weeks. ]
  The SMQ is a parent report measure of how much a child is speaking at home, at school and in social situations
• Preschool Anxiety Scale (PAS) [ Time Frame: Change from Baseline on the PAS within 4 weeks of treatment end and at 6 months post-treatment end. Treatment groups run for 11 weeks. ]
  The PAS is a parent report of child anxiety symptoms and scores range from 0 to 136

Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: September 15, 2015
Date Started: September 2015
Date Completion: September 2017
Last Updated: April 18, 2016
Last Verified: April 2016