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

July 29, 2019 updated by: Weill Medical College of Cornell University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Secret Agent Society (SAS) Program
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.
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
34 weeks. Wk 1, Wk 10, 3-month follow, and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shannon Bennett, PhD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1503015990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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