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Completed

NCT Number: NCT02554929

Treatment of Social Anxiety Disorder and Selective Mutism

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.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Communication Disorders Language Disorders Mental Disorders Mutism Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Phobia, Social Phobic Disorders Selective Mutism Signs and Symptoms Speech Disorders

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Cognitive Behavioral Therapy (CBT)

Parent Psycho-education and Child Socialization

Behavioral

Parents receive psycho-education in parent group and children receive socialization skills in child group.

Other names: Psycho-education and Socialization

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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 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.

  5. 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).

    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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study 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

Acronym: SAD&SMTRMT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2015
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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