Treatment of Social Anxiety Disorder and Selective Mutism (SAD&SMTRMT)

The Hospital for Sick Children

Status: Completed

Conditions: Selective Mutism; Social Anxiety Disorder

Treatments: Behavioral: Taming Sneaky Fears; Behavioral: Parent Psycho-education and Child Socialization

Study type: Interventional

Funder types: Other

Identifiers

NCT02554929

1000050447

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 2 patient groups

Taming Sneaky Fears Group

Experimental group

Description:

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.

Treatment:

Behavioral: Taming Sneaky Fears

Parent Psychoeducation and Child Socialization Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Parent Psycho-education and Child Socialization