Treatment of Social Anxiety Disorder and Selective Mutism

NCT ID: NCT02554929

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-12-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Taming Sneaky Fears Group

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.

Group Type: EXPERIMENTAL

Taming Sneaky Fears

Intervention Type: BEHAVIORAL

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

Parent Psychoeducation and Child Socialization Group

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.

Group Type: ACTIVE_COMPARATOR

Parent Psycho-education and Child Socialization

Intervention Type: BEHAVIORAL

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

Interventions

Taming Sneaky Fears

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

Intervention Type: BEHAVIORAL

Parent Psycho-education and Child Socialization

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive Behavioral Therapy (CBT); Psycho-education and Socialization

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Suneeta Monga

Medical Director, Psychiatry Ambulatory Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suneeta Monga, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 6639293 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18470781 (View on PubMed)

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

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1000050447

Identifier Type: -

Identifier Source: org_study_id