Selective Mutism, Social Anxiety Disorder
Conditions
Keywords
Social Anxiety Disorder, Selective Mutism, CBT, preschool anxiety disorders
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.
Interventions
BEHAVIORALTaming Sneaky Fears
Parents receive coping strategies based on CBT in parent group and children receive coping strategies based on CBT in child group.
BEHAVIORALParent Psycho-education and Child Socialization
Parents receive psycho-education in parent group and children receive socialization skills in child group.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | Change from Baseline in CSR of SAD & SM at 6 months after treatment ends. Treatment groups run for 11 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | Change from Baseline in CSR within 4 weeks of treatment end. Treatment groups run for 11 weeks. | 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. |
| Change in Children's Global Assessment Scale (CGAS) | Change from Baseline on the CGAS within 4 weeks of treatment end. Treatment groups run for 11 weeks. | 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. |
| Selective Mutism Questionnaire (SMQ) | 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 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 Preschool Anxiety Scale - Parent Report | 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). | 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. |
Countries
Canada
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| 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. | 44 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 8 |
Baseline characteristics
| Characteristic | Taming Sneaky Fears Group | Parent Psychoeducation and Child Socialization Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 46 Participants | 44 Participants | 90 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.9 years STANDARD_DEVIATION 1 | 5.8 years STANDARD_DEVIATION 1.1 | 5.9 years STANDARD_DEVIATION 1.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 42 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 10 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 30 Participants | 55 Participants |
| Region of Enrollment Canada | 46 Participants | 44 Participants | 90 Participants |
| Sex: Female, Male Female | 32 Participants | 31 Participants | 63 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 27 Participants |
| The Anxiety Disorders Interview Schedule (ADIS), Clinical Severity Rating (ADIS-CSR) SAD ADIS-CSR Score | 5.2 units on a scale STANDARD_DEVIATION 1.7 | 5.7 units on a scale STANDARD_DEVIATION 1.3 | 5.5 units on a scale STANDARD_DEVIATION 1.6 |
| The Anxiety Disorders Interview Schedule (ADIS), Clinical Severity Rating (ADIS-CSR) SM ADIS-CSR Score | 4.8 units on a scale STANDARD_DEVIATION 2.4 | 4.3 units on a scale STANDARD_DEVIATION 2.5 | 4.5 units on a scale STANDARD_DEVIATION 2.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 44 |
| other Total, other adverse events | 0 / 46 | 0 / 44 |
| serious Total, serious adverse events | 0 / 46 | 0 / 44 |
Outcome results
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.
Time frame: Change from Baseline in CSR of SAD & SM at 6 months after treatment ends. Treatment groups run for 11 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taming Sneaky Fears Group | Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | Change in SAD ADIS-CSR from baseline to 6 months | -1.26 units on a scale | Standard Error 0.35 |
| Taming Sneaky Fears Group | Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | Change in SM ADIS-CSR from baseline to 6 months | -1.51 units on a scale | Standard Error 0.37 |
| Parent Psychoeducation and Child Socialization Group | Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | Change in SAD ADIS-CSR from baseline to 6 months | -1.65 units on a scale | Standard Error 0.37 |
| Parent Psychoeducation and Child Socialization Group | Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | Change in SM ADIS-CSR from baseline to 6 months | -1.24 units on a scale | Standard Error 0.4 |
Comparison: 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.p-value: 0.00295% CI: [-0.91, 0.74]Mixed Models Analysis
Comparison: 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.p-value: 0.00295% CI: [-0.95, 1.48]Mixed Models Analysis
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.
Time frame: Change from Baseline on the CGAS within 4 weeks of treatment end. Treatment groups run for 11 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taming Sneaky Fears Group | Change in Children's Global Assessment Scale (CGAS) | 12.8 units on a scale | Standard Error 2.4 |
| Parent Psychoeducation and Child Socialization Group | Change in Children's Global Assessment Scale (CGAS) | 11.1 units on a scale | Standard Error 2.5 |
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.
Time frame: Change from Baseline on the CGAS at 6 months post-treatment end. Treatment groups run for 11 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taming Sneaky Fears Group | Change in Children's Global Assessment Scale (CGAS) | 15.2 units on a scale | Standard Error 2.5 |
| Parent Psychoeducation and Child Socialization Group | Change in Children's Global Assessment Scale (CGAS) | 14.3 units on a scale | Standard Error 2.6 |
Comparison: 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.p-value: 0.00295% CI: [-4.28, 8.08]Mixed Models Analysis
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.
Time frame: Change from Baseline in CSR within 4 weeks of treatment end. Treatment groups run for 11 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taming Sneaky Fears Group | Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | Change in SAD ADIS-CSR baseline to 4-weeks | -1.12 units on a scale | Standard Error 0.34 |
| Taming Sneaky Fears Group | Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | Change in SM ADIS-CSR baseline to 4-weeks | -1.49 units on a scale | Standard Error 0.37 |
| Parent Psychoeducation and Child Socialization Group | Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | Change in SAD ADIS-CSR baseline to 4-weeks | -1.46 units on a scale | Standard Error 0.37 |
| Parent Psychoeducation and Child Socialization Group | Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P) | Change in SM ADIS-CSR baseline to 4-weeks | -0.66 units on a scale | Standard Error 0.4 |
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.
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taming Sneaky Fears Group | Selective Mutism Questionnaire (SMQ) | Pre-treatment SMQ | 20.0 units on a scale | Standard Deviation 9.6 |
| Taming Sneaky Fears Group | Selective Mutism Questionnaire (SMQ) | Post-treatment SMQ | 26.2 units on a scale | Standard Deviation 9.6 |
| Taming Sneaky Fears Group | Selective Mutism Questionnaire (SMQ) | 6 month follow-up SMQ | 30.2 units on a scale | Standard Deviation 11.9 |
| Parent Psychoeducation and Child Socialization Group | Selective Mutism Questionnaire (SMQ) | Pre-treatment SMQ | 19.2 units on a scale | Standard Deviation 9.5 |
| Parent Psychoeducation and Child Socialization Group | Selective Mutism Questionnaire (SMQ) | Post-treatment SMQ | 23.4 units on a scale | Standard Deviation 9.5 |
| Parent Psychoeducation and Child Socialization Group | Selective Mutism Questionnaire (SMQ) | 6 month follow-up SMQ | 27.6 units on a scale | Standard Deviation 10.1 |
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.
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taming Sneaky Fears Group | The Preschool Anxiety Scale - Parent Report | Pre-treatment PAS-P Score | 36.7 units on a scale | Standard Deviation 20.2 |
| Taming Sneaky Fears Group | The Preschool Anxiety Scale - Parent Report | Post-treatment PAS-P Score | 32.3 units on a scale | Standard Deviation 16 |
| Taming Sneaky Fears Group | The Preschool Anxiety Scale - Parent Report | 6 month follow-up PAS-P Score | 26.5 units on a scale | Standard Deviation 16 |
| Parent Psychoeducation and Child Socialization Group | The Preschool Anxiety Scale - Parent Report | Pre-treatment PAS-P Score | 39.6 units on a scale | Standard Deviation 16.3 |
| Parent Psychoeducation and Child Socialization Group | The Preschool Anxiety Scale - Parent Report | Post-treatment PAS-P Score | 35.8 units on a scale | Standard Deviation 13.4 |
| Parent Psychoeducation and Child Socialization Group | The Preschool Anxiety Scale - Parent Report | 6 month follow-up PAS-P Score | 31.4 units on a scale | Standard Deviation 17.5 |