NCT02554929

Treatment of Social Anxiety Disorder and Selective Mutism

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 Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Social Anxiety Disorder
• Selective Mutism

Interventions

Type	Name	Description
BEHAVIORAL	Taming Sneaky Fears	Parents receive coping strategies based on CBT in parent group and children receive coping strategies based on CBT in child group.
BEHAVIORAL	Parent Psycho-education and Child Socialization	Parents receive psycho-education in parent group and children receive socialization skills in child group.

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-09-18
• Last updated: 2019-10-29
• Results posted: 2019-09-13

Locations

1 site across 1 country: Canada