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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02554929 |
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Date of registration:
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15/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Social Anxiety Disorder and Selective Mutism
SAD&SMTRMT |
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Scientific title:
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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 |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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93 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02554929 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Suneeta Monga, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children |
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Key inclusion & exclusion criteria
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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.
Age minimum:
4 Years
Age maximum:
7 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Selective Mutism
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Social Anxiety Disorder
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Intervention(s)
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Behavioral: Taming Sneaky Fears
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Behavioral: Parent Psycho-education and Child Socialization
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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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.]
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Selective Mutism Questionnaire (SMQ)
[Time Frame: The SMQ was completed by parents at all 3 time-points: 1) Pre-treatment (baseline), 2) Post-treatment, and 3) 6-month follow-up (from baseline date).]
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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.]
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Change in Children's Global Assessment Scale (CGAS)
[Time Frame: Change from Baseline on the CGAS within 4 weeks of treatment end. Treatment groups run for 11 weeks.]
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The Preschool Anxiety Scale - Parent Report
[Time Frame: The PAS-P was completed by parents at all 3 time-points: 1) Pre-treatment (baseline), 2) Post-treatment, and 3) 6-month follow-up (from baseline date).]
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Secondary ID(s)
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1000050447
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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