Social Anxiety Disorder Clinical Trial
— SAD&SMTRMTOfficial 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
NCT number | NCT02554929 |
Other study ID # | 1000050447 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | December 2017 |
Verified date | October 2019 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 93 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 7 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
Albano, A. M., & Silverman, W. K. (1996). Anxiety Disorders Interview Schedule for DSM-IV-Child Version: Clinician Manual. Psychological Corporation.
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. — View Citation
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. — View Citation
Spence, S. H., & Rapee, R. (1999). Preschool anxiety scale (parent report). Brisbane, Australia: University of Queensland.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Change from Baseline in CSR of SAD & SM at 6 months after treatment ends. Treatment groups run for 11 weeks. | |
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. | 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. | 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. | 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. | 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). | |
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. | 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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