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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taming Sneaky Fears Group | Experimental | 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. |
|
| Parent Psychoeducation and Child Socialization Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taming Sneaky Fears | Behavioral | Parents receive coping strategies based on CBT in parent group and children receive coping strategies based on CBT in child group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | The Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV): Parent Version (ADIS-P) 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. | Change from Baseline in CSR of SAD & SM at 6 months after treatment ends. Treatment groups run for 11 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | The Anxiety Disorders Interview Schedule for DSM-IV: Parent Version (ADIS-P) 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suneeta Monga, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Albano, A. M., & Silverman, W. K. (1996). Anxiety Disorders Interview Schedule for DSM-IV-Child Version: Clinician Manual. Psychological Corporation. | ||
| 6639293 | 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. | |
| 18470781 |
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Of the n=93 consented participants, 3 withdrew consent prior to randomization and treatment assignment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Taming Sneaky Fears Group | 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. |
| FG001 | 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 (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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Taming Sneaky Fears Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | The Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV): Parent Version (ADIS-P) 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline in CSR of SAD & SM at 6 months after treatment ends. Treatment groups run for 11 weeks. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Taming Sneaky Fears Group | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suneeta Monga | The Hospital for Sick Children | 416-813-8954 | suneeta.monga@sickkids.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2016 | Aug 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| D009155 | Mutism |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D013064 | Speech Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Parent Psycho-education and Child Socialization | Behavioral | Parents receive psycho-education in parent group and children receive socialization skills in child group. |
|
|
| Change from Baseline in CSR within 4 weeks of treatment end. Treatment groups run for 11 weeks. |
| Change in Children's Global Assessment Scale (CGAS) | The Children's Global Assessment Scale (CGAS) 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. | Change from Baseline on the CGAS within 4 weeks of treatment end. Treatment groups run for 11 weeks. |
| Change in Children's Global Assessment Scale (CGAS) | The Children's Global Assessment Scale (CGAS) 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. | Change from Baseline on the CGAS at 6 months post-treatment end. Treatment groups run for 11 weeks. |
| Selective Mutism Questionnaire (SMQ) | The Selective Mutism Questionnaire (SMQ) 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. | 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). |
| The Preschool Anxiety Scale - Parent Report | The Preschool Anxiety Scale - Parent report (PAS-P) 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. | 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). |
| Background |
| 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. |
| Background | Spence, S. H., & Rapee, R. (1999). Preschool anxiety scale (parent report). Brisbane, Australia: University of Queensland. |
| BG001 | 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 (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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| The Anxiety Disorders Interview Schedule (ADIS), Clinical Severity Rating (ADIS-CSR) | 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. | Mean | Standard Deviation | units on a scale |
|
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.
| OG001 | 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 (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. |
|
|
|
| Secondary | Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | The Anxiety Disorders Interview Schedule for DSM-IV: Parent Version (ADIS-P) 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline in CSR within 4 weeks of treatment end. Treatment groups run for 11 weeks. |
|
|
|
| Secondary | Change in Children's Global Assessment Scale (CGAS) | The Children's Global Assessment Scale (CGAS) 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline on the CGAS within 4 weeks of treatment end. Treatment groups run for 11 weeks. |
|
|
|
| Secondary | Change in Children's Global Assessment Scale (CGAS) | The Children's Global Assessment Scale (CGAS) 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. | Posted | Mean | Standard Error | units on a scale | Change from Baseline on the CGAS at 6 months post-treatment end. Treatment groups run for 11 weeks. |
|
|
|
|
| Secondary | Selective Mutism Questionnaire (SMQ) | The Selective Mutism Questionnaire (SMQ) 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. | Posted | Mean | Standard Deviation | units on a scale | 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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|
| Secondary | The Preschool Anxiety Scale - Parent Report | The Preschool Anxiety Scale - Parent report (PAS-P) 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. | Posted | Mean | Standard Deviation | units on a scale | 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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|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | 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 (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. | 0 | 44 | 0 | 44 | 0 | 44 |
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| D007806 |
| Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
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.
| Superiority |
| 6 month follow-up SMQ |
|
| 6 month follow-up PAS-P Score |
|