AnxietyNCT02574273

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

A study testing Secret Agent Society (SAS) Program and Waitlist Group / Treatment As Usual in people with Anxiety and Attention Deficit Hyperactivity Disorder (ADHD), run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 \&… Read more about this study

Who is it for?: Ages 8 to 12 years
Conditions the study is for: Anxiety, Attention Deficit Hyperactivity Disorder (ADHD), Autistic Spectrum Disorder (ASD)
What is being tested?: Secret Agent Society (SAS) Program and Waitlist Group / Treatment As Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteUnited States
Study dates: Oct 2015to Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

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 8 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medical College
New York, New York, 10065

Other trials in United States

About this study

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

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.

Read the 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)
Being tested: Secret Agent Society (SAS) Program, Waitlist Group / Treatment As Usual
Medical subject headings: Anxiety Disorders, Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Secret Agent Society (SAS) ProgramBehavioural
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.
Waitlist Group / Treatment As UsualOther
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.

Study groups in NCT02574273
Study group	Role	What they receive
Secret Agent Society (SAS) Program	Active comparator	The Secret Agent Society (SAS) Program is an intervention which 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. Parents will attend weekly parent support training sessions. 3 and 6 month booster sessions are conducted with both parents and children to help families with maintaining the skills that they have learned and to problem-solve new challenges that arise. 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, for both parent and child participants. Receives: Behavioral: Secret Agent Society (SAS) Program
Waitlist Group / Treatment As Usual	Other	Participants may be randomly allocated to the wait list control condition, where participants will receive treatment as usual during the 3 month period when the intervention group will participate in the SAS Program. The wait-list group will then be given the opportunity to participate in the SAS intervention at their treating clinic. 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. Receives: Other: Waitlist Group / Treatment As Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Anxiety Disorders Interview Schedule for DSM-IV-Child Version (ADIS)
Change in anxiety will be measured at these time points.
Measured: 34 weeks. Wk 1, Wk 10, 3-month follow, and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Dec 2018

First posted12 Oct 2015 (estimated)
Study startOct 2015
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe 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: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02574273
Sponsor's protocol ID: 1503015990
Status last verified: Jul 2019
First submitted: 8 Oct 2015
Last updated: 30 Jul 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 24337829
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 2014.
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.
PubMed 18503531
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 schools. Manuscript submitted for publication.
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. Accepted January 2015.
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.
Temkin AB, Beaumont R, Wkya K, Hariton JR, Flye BL, Sheridan E, Miranda A, Vela J, Zendegui E, Schild J, Gasparro S, Loubriel D, Damianides A, Weisman J, Silvestre A, Yadegar M, Catarozoli C, Bennett SM. Secret Agent Society: A Randomized Controlled Trial of a Transdiagnostic Youth Social Skills Group Treatment. Res Child Adolesc Psychopathol. 2022 Sep;50(9):1107-1119. doi: 10.1007/s10802-022-00919-z. Epub 2022 Apr 20.
PubMed 35441908

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Trial of a Social Skills Group Treatment (Secret Agent Society Program) for Youth With Anxiety, ADHD, or Autistic Disorder
ClinicalTrials.gov ID: NCT02574273
Acronym / sponsor ID: 1503015990
Conditions: Anxiety, Attention Deficit Hyperactivity Disorder (ADHD), Autistic Spectrum Disorder (ASD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Study start: Oct 2015
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 12 Oct 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Secret Agent Society (SAS) Program	Active comparator	Behavioral: Secret Agent Society (SAS) ProgramThe Secret Agent Society (SAS) Program is an intervention which 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. Parents will attend weekly parent support training sessions. 3 and 6 month booster sessions are conducted with both parents and children to help families with maintaining the skills that they have learned and to problem-solve new challenges that arise. 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, for both parent and child participants.
Waitlist Group / Treatment As Usual	Other	Other: Waitlist Group / Treatment As UsualParticipants may be randomly allocated to the wait list control condition, where participants will receive treatment as usual during the 3 month period when the intervention group will participate in the SAS Program. The wait-list group will then be given the opportunity to participate in the SAS intervention at their treating clinic. 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.

Who may qualify

Ages: 8 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (3 listed)

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).

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
Secret Agent Society (SAS) ProgramThe 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.	Behavioural	Secret Agent Society (SAS) Program
Waitlist Group / Treatment As UsualThe 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.	Other	Waitlist Group / Treatment As Usual

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Background: PubMed 24337829Butterworth 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.
Results publicationBeaumont, 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 2014.
Results publication: PubMed 18503531Beaumont 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.
Results publicationEinfeld, 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 schools. Manuscript submitted for publication.
Results publicationPearson, R., Sofronoff, K., & Beaumont, R. (2015). Preliminary evaluation of the 'Secret Agent Society' social-emotional skills programme with typically developing children. Manuscript in preparation.
Results publicationSofronoff, 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. Accepted January 2015.
Results publicationTan, 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.
Derived from this study: PubMed 35441908Temkin AB, Beaumont R, Wkya K, Hariton JR, Flye BL, Sheridan E, Miranda A, Vela J, Zendegui E, Schild J, Gasparro S, Loubriel D, Damianides A, Weisman J, Silvestre A, Yadegar M, Catarozoli C, Bennett SM. Secret Agent Society: A Randomized Controlled Trial of a Transdiagnostic Youth Social Skills Group Treatment. Res Child Adolesc Psychopathol. 2022 Sep;50(9):1107-1119. doi: 10.1007/s10802-022-00919-z. Epub 2022 Apr 20.
Individual participant dataSharing planned: No

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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.

Shannon Bennett, PhD principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 3 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 30 Jul 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Anxiety Disorders Interview Schedule for DSM-IV-Child Version (ADIS) (time frame: 34 weeks. Wk 1, Wk 10, 3-month follow, and 6-month follow-up). 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 NCT02574273, which also lists 8 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 30 Jul 2019.