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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574273
• Other study ID #: 1503015990
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children are required to be aged between 8 and 12 years at the time of study entry.

• Children must have a diagnosis of an anxiety disorder, Attention Deficit Hyperactivity disorder and/or Autism Spectrum Disorder and whose parents report that they experience social difficulties/are socially excluded by peers. Participants are not eligible to participate in the study if they do not meet any of the listed diagnoses.

• Children must have an IQ of 85 or above (as formally assessed within the past 2 years, or as assessed at the time of study entry by WIAT III Verbal Subtest).

• Children are required to have significant social difficulties as reported by their parents and/or teacher (although they are not required to score within the clinical range on the Spence Social Skills Questionnaire to be included in the study).

• Children and parents must be fluent in English (preferably their first language).

Exclusion Criteria:

• Failure to meet one or more of the Inclusion Criteria listed above.

• Parents indicate at intake that they are unwilling or unable to attend the parent training sessions and to support their child in completing between-session skills practice tasks ('home missions').

• Children who present with extreme levels of anxiety and anger (as determined from intake interviews and questionnaires), and as such, group therapy would be contraindicated at that time (would cause extreme distress to a child and/or s/he would be a physical safety risk to other child group members).

Related Conditions & MeSH terms

• Anxiety
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Autism Spectrum Disorder
• Autistic Disorder
• Autistic Spectrum Disorder (ASD)
• Child Development Disorders, Pervasive
• Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Beaumont R, Sofronoff K. A multi-component social skills intervention for children with Asperger syndrome: the Junior Detective Training Program. J Child Psychol Psychiatry. 2008 Jul;49(7):743-53. doi: 10.1111/j.1469-7610.2008.01920.x. Epub 2008 Jul 1. Er — View Citation

Beaumont, R., Rotolone, C., & Sofronoff, K. (in press). The Secret Agent Society social skills program for children with a high-functioning autism spectrum disorders: A comparison of two brief versions for schools. Psychology in the Schools. Accepted May

Butterworth TW, Hodge MA, Sofronoff K, Beaumont R, Gray KM, Roberts J, Horstead SK, Clarke KS, Howlin P, Taffe JR, Einfeld SL. Validation of the emotion regulation and social skills questionnaire for young people with autism spectrum disorders. J Autism Dev Disord. 2014 Jul;44(7):1535-45. doi: 10.1007/s10803-013-2014-5. — View Citation

Einfeld, S., Sofronoff, K., Gray, K., Roberts, J., Taffe, J., Clark, T., Costley, D., Redoblado Hodge, M.A., Horstead, S., Clarke, K., Beaumont, R., & Howlin, P. (2015). An evaluation of a social skills program for children with autism in specialist schoo

Pearson, R., Sofronoff, K., & Beaumont, R. (2015). Preliminary evaluation of the 'Secret Agent Society' social-emotional skills programme with typically developing children. Manuscript in preparation.

Sofronoff, K., Silva, J., & Beaumont, R. (2014). Parent delivery of the Secret Agent Society social-emotional skills training program for children with high-functioning autism spectrum disorders. Focus on Autism and Other Developmental Disabilities. Accep

Tan, Y.L., Mazzucchelli, T.G., & Beaumont, R. (2015). An evaluation of individually delivered Secret Agent Society social skills program for children with high-functioning autism spectrum disorders: A pilot study. Manuscript submitted for publication.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Disorders Interview Schedule for DSM-IV—Child Version (ADIS)	Change in anxiety will be measured at these time points.	34 weeks. Wk 1, Wk 10, 3-month follow, and 6-month follow-up