NCT02574273

Pilot Trial of a Social Skills Group Treatment (Secret Agent Society Program)

Pilot Trial of a Social Skills Group Treatment (Secret Agent Society Program) for Youth With Anxiety, ADHD, or Autistic Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Several independent evaluations have supported the effectiveness of the Secret Agent Society (SAS) Program in improving the social-emotional functioning of children with Autism Spectrum Disorders (ASD) in clinic- (Beaumont \& Sofronoff, 2008; Tan, Mazzucchelli \& Beaumont, submitted), school-(Beaumont, Rotolone \& Sofronoff, in press; Einfeld et al., submitted) and remote Skype/telephone-assisted delivery contexts (Sofronoff, Silva \& Beaumont, in press).The present study aims to extend on the above literature by conducting a 6-month randomized controlled trial evaluating the effectiveness, utility and acceptability (including cultural acceptability) of the Secret Agent Society (SAS) social-emotional skills training program. Specifically, the study aims to evaluate the effectiveness of the SAS Program for 8-12 year-old children with social difficulties in the context of a range of diagnosed mental health conditions and/or developmental disorders, including anxiety disorders, ADHD, and Autism Spectrum Disorder.

Detailed description

Several independent evaluations have supported the effectiveness of the Secret Agent Society (SAS) Program in improving the social-emotional functioning of children with Autism Spectrum Disorders (ASD) in clinic, school and remote Skype/telephone-assisted delivery contexts. Results from a pilot University clinic evaluation of the program for children with social-emotional difficulties but without ASD has also yielded positive findings, showing comparable treatment effects to those achieved for children with ASD in terms of improved social-emotional functioning. Within the USA, results from a two-year Buffalo School District implementation project and delivery of the program through USC University Center for Excellence in Developmental Disabilities (UCEDD Children's Hospital Los Angeles) have provided further support for the effectiveness and cross-cultural appropriateness of the intervention with children who have a range of mental health challenges. The present study aims to extend on the above literature by conducting a 6-month randomized controlled trial evaluating the effectiveness, utility and acceptability (including cultural acceptability) of the Secret Agent Society (SAS) social-emotional skills training program. Specifically, the study aims to evaluate the effectiveness of the SAS Program for 8-12 year-old children with social difficulties in the context of a range of diagnosed mental health conditions and/or developmental disorders, including anxiety disorders, ADHD, and Autism Spectrum Disorder. Outcome variables will include measures of child social functioning and mental health outcomes related to their primary diagnoses (e.g. anxiety, disruptive behaviour, etc).

Conditions

• Anxiety
• Attention Deficit Hyperactivity Disorder (ADHD)
• Autistic Spectrum Disorder (ASD)

Interventions

Type	Name	Description
BEHAVIORAL	Secret Agent Society (SAS) Program	The Secret Agent Society (SAS) intervention involves subjects participating in 9 weekly two-hour therapy groups ('Club meetings') with 3 to 6 other children. The SAS intervention includes a number of components to help children apply the skills that they learn in the session to home.
OTHER	Waitlist Group / Treatment As Usual	The wait list control condition includes the treatment participants are already receiving (which may include but is not limited to: individual therapy, group therapy, and/or medication management). Therefore, the wait list control condition consists of treatment which is individually tailored for each participant. Parent and child assessments will be completed at pre and post treatment (Wk 1 and Wk 10) and at 3-month and 6-month follow-up booster visits. The wait-list group will then be given the opportunity to participate in the SAS intervention at their treating clinic.

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-10-12
• Last updated: 2019-07-30

Locations

1 site across 1 country: United States