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

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ClinicalTrials.gov Identifier: NCT02554929
Recruitment Status : Unknown
Verified July 2017 by Suneeta Monga, The Hospital for Sick Children.
Recruitment status was:  Active, not recruiting
First Posted : September 18, 2015
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Suneeta Monga, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Selective Mutism Behavioral: Taming Sneaky Fears Behavioral: Parent Psycho-education and Child Socialization Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Trial
Study Start Date : September 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Cogntive Behavioral Therapy (CBT)

Active Comparator: 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.
Behavioral: Parent Psycho-education and Child Socialization
Parents receive psycho-education in parent group and children receive socialization skills in child group.
Other Name: Psycho-education and Socialization




Primary Outcome Measures :
  1. 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. ]
    The Clinical Severity Ratings range from 0 (no symptoms) to 8 (severe symptoms) with a rating of 4 indicating "meets diagnostic level"


Secondary Outcome Measures :
  1. 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"

  2. 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.

  3. 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.

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554929


Locations
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Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Suneeta Monga, MD The Hospital for Sick Children

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Responsible Party: Suneeta Monga, Medical Director, Psychiatry Ambulatory Services, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02554929     History of Changes
Other Study ID Numbers: 1000050447
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

Keywords provided by Suneeta Monga, The Hospital for Sick Children:
Social Anxiety Disorder
Selective Mutism
CBT
preschool anxiety disorders

Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Phobia, Social
Mutism
Pathologic Processes
Mental Disorders
Phobic Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders