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

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ClinicalTrials.gov Identifier: NCT02554929
Recruitment Status : Completed
First Posted : September 18, 2015
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Suneeta Monga, The Hospital for Sick Children

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Social Anxiety Disorder
Selective Mutism
Interventions Behavioral: Taming Sneaky Fears
Behavioral: Parent Psycho-education and Child Socialization
Enrollment 93
Recruitment Details This study was conducted at the Hospital for Sick Children (SickKids). Children, aged 4-7 years, were screened to participate in the treatment study by one of the principal investigators (child psychiatrists) at an anxiety disorders clinic in SickKids.
Pre-assignment Details Of the n=93 consented participants, 3 withdrew consent prior to randomization and treatment assignment.
Arm/Group Title Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Hide Arm/Group Description

An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child 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 (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group.

Period Title: Overall Study
Started 46 44
Per Protocol Received Intervention 44 36
Per Protocol Post-Intervention 42 36
Per Protocol 6 Month Follow-up 40 32
Completed 40 32
Not Completed 6 12
Reason Not Completed
Lost to Follow-up             4             4
Withdrawal by Subject             2             8
Arm/Group Title Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group Total
Hide Arm/Group Description

An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child 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 (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group.

Total of all reporting groups
Overall Number of Baseline Participants 46 44 90
Hide Baseline Analysis Population Description
4 to 7 year old children referred for psychiatric assessment of SM and/or social anxiety disorder (SAD) who met diagnostic criteria for SM and/or SAD as a primary diagnosis, as determined by one of the psychiatrists at the site where the study was conducted.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
<=18 years
46
 100.0%
44
 100.0%
90
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 44 participants 90 participants
5.9  (1.0) 5.8  (1.1) 5.9  (1.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
Female
32
  69.6%
31
  70.5%
63
  70.0%
Male
14
  30.4%
13
  29.5%
27
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
Hispanic or Latino
1
   2.2%
2
   4.5%
3
   3.3%
Not Hispanic or Latino
45
  97.8%
42
  95.5%
87
  96.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
12
  26.1%
10
  22.7%
22
  24.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.2%
2
   4.5%
3
   3.3%
White
25
  54.3%
30
  68.2%
55
  61.1%
More than one race
8
  17.4%
2
   4.5%
10
  11.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 46 participants 44 participants 90 participants
46
 100.0%
44
 100.0%
90
 100.0%
The Anxiety Disorders Interview Schedule (ADIS), Clinical Severity Rating (ADIS-CSR)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 46 participants 44 participants 90 participants
SAD ADIS-CSR Score 5.2  (1.7) 5.7  (1.3) 5.5  (1.6)
SM ADIS-CSR Score 4.8  (2.4) 4.3  (2.5) 4.5  (2.5)
[1]
Measure Description: The ADIS-CSR was used to assess SAD and/or SM. This measure has good reliability, is sensitive to treatment effects in child anxiety studies, and has been used in a number of studies on preschoolers and SM treatment. Clinical Severity Rating (ADIS-CSR) uses a 0 to 8 scale to measure clinical severity of diagnosis; a CSR of ≥4 indicates clinically significant symptoms and presence of an anxiety disorder. A trained independent clinician blinded to treatment type and time of assessment completed the CSR.
1.Primary Outcome
Title Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)
Hide Description The Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV): Parent Version (ADIS-P) (Silverman & Albano, 1996) is a semi-structured, clinician-administered, interview of parents used to diagnose anxiety and other related disorders in children and adolescents. Parents were asked to rate for interference or impairment using a 9-point scale ranging from 0 to 8, with 0 being not impaired or not interfering and 8 being significant impairment or interference. A final Clinician Severity Rating (CSR) was then established using the same scale, with a CSR of 4 (moderate degree of impairment) or greater required to establish a diagnosis.
Time Frame Change from Baseline in CSR of SAD & SM at 6 months after treatment ends. Treatment groups run for 11 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Hide Arm/Group Description:

An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child 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 (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group.

Overall Number of Participants Analyzed 46 44
Mean (Standard Error)
Unit of Measure: units on a scale
Change in SAD ADIS-CSR from baseline to 6 months -1.26  (0.35) -1.65  (0.37)
Change in SM ADIS-CSR from baseline to 6 months -1.51  (0.37) -1.24  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Taming Sneaky Fears Group, Parent Psychoeducation and Child Socialization Group
Comments In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.91 to 0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.42
Estimation Comments Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SAD.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Taming Sneaky Fears Group, Parent Psychoeducation and Child Socialization Group
Comments In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.95 to 1.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.62
Estimation Comments Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SM.
2.Secondary Outcome
Title Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)
Hide Description The Anxiety Disorders Interview Schedule for DSM-IV: Parent Version (ADIS-P) (Silverman & Albano, 1996) is a semi-structured, clinician-administered, interview of parents used to diagnose anxiety and other related disorders in children and adolescents. Parents were asked to rate for interference or impairment using a 9-point scale ranging from 0 to 8, with 0 being not impaired or not interfering and 8 being significant impairment or interference. A final Clinician Severity Rating (CSR) was then established using the same scale, with a CSR of 4 (moderate degree of impairment) or greater required to establish a diagnosis.
Time Frame Change from Baseline in CSR within 4 weeks of treatment end. Treatment groups run for 11 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Hide Arm/Group Description:

An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child 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 (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group.

Overall Number of Participants Analyzed 46 44
Mean (Standard Error)
Unit of Measure: units on a scale
Change in SAD ADIS-CSR baseline to 4-weeks -1.12  (0.34) -1.46  (0.37)
Change in SM ADIS-CSR baseline to 4-weeks -1.49  (0.37) -0.66  (0.40)
3.Secondary Outcome
Title Change in Children's Global Assessment Scale (CGAS)
Hide Description The Children’s Global Assessment Scale (CGAS; Shaffer et al., 1983) is a clinician rating of overall adaptive functioning during the previous month for children and adolescents between 4 to 16 years of age. CGAS scores are rated on a 100-point scale, with 1 being the most impaired and 100 being least impaired, and descriptors for each 10-point interval such that each 10-point interval defines a range of children’s functioning in all areas of their life. CGAS scores were secondary outcome measures. The Change in Children's Global Assessment Scale (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.
Time Frame Change from Baseline on the CGAS within 4 weeks of treatment end. Treatment groups run for 11 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Hide Arm/Group Description:

An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child 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 (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group.

Overall Number of Participants Analyzed 46 44
Mean (Standard Error)
Unit of Measure: units on a scale
12.8  (2.4) 11.1  (2.5)
4.Secondary Outcome
Title Change in Children's Global Assessment Scale (CGAS)
Hide Description The Children’s Global Assessment Scale (CGAS; Shaffer et al., 1983) is a clinician rating of overall adaptive functioning during the previous month for children and adolescents between 4 to 16 years of age. CGAS scores are rated on a 100-point scale, with 1 being the most impaired and 100 being least impaired, and descriptors for each 10-point interval such that each 10-point interval defines a range of children’s functioning in all areas of their life. CGAS scores were secondary outcome measures. The Change in Children's Global Assessment Scale (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.
Time Frame Change from Baseline on the CGAS at 6 months post-treatment end. Treatment groups run for 11 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Hide Arm/Group Description:

An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child 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 (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group.

Overall Number of Participants Analyzed 46 44
Mean (Standard Error)
Unit of Measure: units on a scale
15.2  (2.5) 14.3  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Taming Sneaky Fears Group, Parent Psychoeducation and Child Socialization Group
Comments In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.89
Confidence Interval (2-Sided) 95%
-4.28 to 8.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.14
Estimation Comments The estimated value of the estimation parameter corresponds to the difference between change in CGAS scores for participants in the CBT arm, in comparison to those in the socialization arm, from pre-treatment to 6-month follow-up.
5.Secondary Outcome
Title Selective Mutism Questionnaire (SMQ)
Hide Description The Selective Mutism Questionnaire (SMQ; Bergman et al., 2008) is a 17-item parent questionnaire that assesses the degree and frequency of speech in 3-to-11-year-old children and provides a proxy measure of selective mutism severity. Parents report on their child’s behavior with regards to speaking in the previous two weeks across three broad domains (or subscales): at school (five items), at home/with family (five items), and in social situations (seven items). Parents rate items using a three-point scale that ranges from 0 = never to 3 = always. Lower total scores on the Selective Mutism Questionnaire suggest less speech.
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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Hide Arm/Group Description:

An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child 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 (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment SMQ 20.0  (9.6) 19.2  (9.5)
Post-treatment SMQ 26.2  (9.6) 23.4  (9.5)
6 month follow-up SMQ 30.2  (11.9) 27.6  (10.1)
6.Secondary Outcome
Title The Preschool Anxiety Scale – Parent Report
Hide Description The Preschool Anxiety Scale – Parent report (PAS-P; Spence & Rapee, 1999) is a 29-item parent-report questionnaire for use with 3- to 6-year-old children. Parents report on their child's anxiety symptoms in different scenarios. Parents rate items on a 5-point Likert scale.
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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Hide Arm/Group Description:

An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child 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 (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group.

Overall Number of Participants Analyzed 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-treatment PAS-P Score 36.7  (20.2) 39.6  (16.3)
Post-treatment PAS-P Score 32.3  (16) 35.8  (13.4)
6 month follow-up PAS-P Score 26.5  (16) 31.4  (17.5)
Time Frame Adverse events were assessed from September 2015 – December 2017, from treatment start date, to 6 months following administration. Adverse events were collected through self-report and participants were encouraged to share any concerns. However, given that this was a psychotherapy trial, no participants reported any adverse events.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Hide Arm/Group Description

An 11 week (introduction plus 10 week) manualized treatment protocol utilizing cognitive behavioral therapy (CBT) strategies specifically developed for children 4 to 7 years of age with social anxiety disorder (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Taming Sneaky Fears: Parents received coping strategies based on CBT in parent group and children received coping strategies based on CBT in child 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 (SAD) and/or selective mutism (SM). Parent and child groups were conducted separately but concurrently.

Parent Psycho-education and Child Socialization: Parents received psycho-education in parent group and children received socialization skills in child group.

All-Cause Mortality
Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/44 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/44 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Taming Sneaky Fears Group Parent Psychoeducation and Child Socialization Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/44 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Suneeta Monga
Organization: The Hospital for Sick Children
Phone: 416-813-8954
EMail: suneeta.monga@sickkids.ca
Layout table for additonal information
Responsible Party: Suneeta Monga, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02554929     History of Changes
Other Study ID Numbers: 1000050447
First Submitted: September 15, 2015
First Posted: September 18, 2015
Results First Submitted: August 9, 2019
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019