Social Anxiety DisorderSAD&SMTRMTNCT02554929
Treatment of Social Anxiety Disorder and Selective Mutism
A study testing Taming Sneaky Fears and Parent Psycho-education and Child Socialization in people with Social Anxiety Disorder and Selective Mutism, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Social Anxiety Disorder, Selective Mutism
- What is being tested?
- Taming Sneaky Fears and Parent Psycho-education and Child Socialization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- Taming Sneaky Fears for SAD and/or SM parent and child group CBT treatment, or
- 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.
- Conditions
- Social Anxiety Disorder, Selective Mutism
- Being tested
- Taming Sneaky Fears, Parent Psycho-education and Child Socialization
- Keywords
- Social Anxiety Disorder, Selective Mutism, CBT, preschool anxiety disorders
- Medical subject headings
- Phobia, Social, Mutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taming Sneaky FearsBehavioural
Also called Cognitive Behavioral Therapy (CBT)
Parents receive coping strategies based on CBT in parent group and children receive coping strategies based on CBT in child group.
Parent Psycho-education and Child SocializationBehavioural
Also called Psycho-education and Socialization
Parents receive psycho-education in parent group and children receive socialization skills in child group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Taming Sneaky Fears |
| 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. Receives: Behavioral: Parent Psycho-education and Child Socialization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline in CSR of SAD & SM at 6 months after treatment ends. Treatment groups run for 11 weeks.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suneeta Monga, The Hospital for Sick Children
- Investigators
- Suneeta Monga, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554929
- Sponsor's protocol ID
- 1000050447
- Acronym
- SAD&SMTRMT
- Status last verified
- Oct 2019
- First submitted
- 15 Sep 2015
- Last updated
- 29 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Albano, A. M., & Silverman, W. K. (1996). Anxiety Disorders Interview Schedule for DSM-IV-Child Version: Clinician Manual. Psychological Corporation.
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.
PubMed 6639293Bergman 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.
PubMed 18470781Spence, S. H., & Rapee, R. (1999). Preschool anxiety scale (parent report). Brisbane, Australia: University of Queensland.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02554929
- Acronym / sponsor ID
- SAD&SMTRMT / 1000050447
- Conditions
- Social Anxiety Disorder, Selective Mutism
- Keywords
- Social Anxiety Disorder, Selective Mutism, CBT, preschool anxiety disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Taming Sneaky Fears for SAD and/or SM parent and child group CBT treatment, or
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taming Sneaky Fears Group | Experimental | Behavioral: Taming Sneaky FearsAn 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 | Behavioral: Parent Psycho-education and Child SocializationAn 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taming Sneaky FearsAlso: Cognitive Behavioral Therapy (CBT)Parents receive coping strategies based on CBT in parent group and children receive coping strategies based on CBT in child group. | Behavioural | Taming Sneaky Fears Group |
| Parent Psycho-education and Child SocializationAlso: Psycho-education and SocializationParents receive psycho-education in parent group and children receive socialization skills in child group. | Behavioural | Parent Psychoeducation and Child Socialization Group |
Primary outcome
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 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.
5 secondary outcomes
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.
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.
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.
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).
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAlbano, A. M., & Silverman, W. K. (1996). Anxiety Disorders Interview Schedule for DSM-IV-Child Version: Clinician Manual. Psychological Corporation.
- Background: PubMed 6639293Shaffer 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.
- Background: PubMed 18470781Bergman 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.
- BackgroundSpence, S. H., & Rapee, R. (1999). Preschool anxiety scale (parent report). Brisbane, Australia: University of Queensland.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suneeta Monga, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taming Sneaky Fears and Parent Psycho-education and Child Socialization in people with Social Anxiety Disorder and Selective Mutism, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02554929, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.