The Secret Agent Society Operation Regulation intervention
| ISRCTN | ISRCTN67079741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67079741 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/09/2013
- Registration date
- 16/10/2013
- Last edited
- 11/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Youth with high functioning autism spectrum disorders (HFASD) often struggle with anxiety, depression, or anger as a result of difficulty in regulating their emotions. There are a number of cognitive behavioral interventions that are designed to address factors related to anxiety in youth with HFASD, but few are designed to build emotion regulation skills more broadly. The Secret Agent Society: Operation Regulation adapts the pre-existing and widely available materials from the Secret Agent Society to help children with ASD build these skills. The Secret Agent Society is a cognitive behavioral social skills group intervention for children with ASD that has been shown to be effective in fostering social skills. A variety of activities and tools, like an emotion focused computer game, cue cards, in session games, and parent and teacher handouts, will be used to engage youth with HFASD in developing skills to help them cope with their emotions and to better handle the day-to-day stressors in their lives.
Who can participate?
Children (both male and female) between 8 and 12 years of age with a formal diagnosis of high functioning autism spectrum disorder or Asperger Syndrome. Children need to have at least average language skills, IQ scores of 85 or above, and be interested in working on emotions with a therapist.
What does the study involve?
All participants receive the same treatment (i.e. go through the intervention), but half of the participants are randomly allocated to receive the treatment immediately and the other half are put on a waiting list for 10 weeks before receiving the 10-week intervention. The intervention is provided individually to children.
What are the benefits and risks of participating?
Given that this therapy has been shown to improve social skills and appropriate control of emotional levels in children, participation in the program may result in a reduction of children's levels of negative emotions and improvement in social skills. Participants may also benefit from the attention and support provided by the graduate student therapist through the weekly one-on-one therapy sessions. The risk to parents may include fatigue related to the completion of questionnaires, as well as feelings of discomfort generated by the content of the questions asked, in particular the questions relating to the child's experience of distressing feelings (e.g., anger, frustration, sadness). Many children with ASD have already completed the Secret Agent Society program, and it is well received by parents and youth. The spy watches may result in the temporary transfer of gray marks from the watch sensors to the child's skin surface, but the marks may be easily washed off with some soap and water. These watches have been found to be minimally invasive and rely on small electrical signals to measure the childs electrodermal activity - these electrical signals are not harmful and transmit less than 0.000001 of the power of a static charge one receives when touching a door knob in a dry room.
Where is the study run from?
York University (Canada)
When is the study starting and how long is it expected to run for?
October 2013 to September 2017
Who is funding the study?
The Spectrum of Hope Autism Foundation (Canada) will be funding this study. The principal investigator is support by a Chair in Autism Spectrum Disorders Treatment and Care Research.
Who is the main contact?
Paula Tablon
tablonp@yorku.ca
Contact information
Scientific
4700 Keele Street
250 Behavioural Sciences Building
Toronto
M3J 1P3
Canada
| tablonp@yorku.ca |
Study information
| Study design | Two-year randomized waitlist controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Paula Tablon (tablonp@yorku.ca) to request a patient information sheet |
| Scientific title | The Secret Agent Society Operation Regulation intervention: a randomized controlled trial |
| Study acronym | SAS-OR |
| Study hypothesis | The hypothesis is that those in the treatment group will show significant improvements in emotional regulation skills compared to those in the waitlist control group. |
| Ethics approval(s) | Regional Ethics Board (REB), 20/08/2013, ref: #e2013-229 |
| Condition | Autism Spectrum Disorders |
| Intervention | Half of the children will be assigned to the treatment condition immediately (provided with the emotion regulation training program immediately after the initial assessments), and the other half of the will be assigned to the waitlist control condition (asked to wait 10 weeks before receiving the intervention). Random number generated lists have been developed for males and females separately, given the higher ratio of males in the ASD population. Random assignment will occur after baseline assessment is complete. The program involves 10 weekly 1-hour visits to the university where the parent and child will meet with a trained therapist for one-on-one therapy. During these sessions, the child will get to do an assortment of activities and play games computer games, problem solving tasks, role playing, and working with the therapist and parent. Post intervention assessments will be carried out following the 10th session of treatment. Ten weeks post intervention, children and parents will be invited back to the university for a follow-up assessment. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measures as of 01/02/2016: Parent and child reports of emotion regulation skills, as measured by: 1. The parent reported: 1.1. Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997) 1.2. Emotion Regulation and Social Skills Questionnaire - Parent (ERSSQ-P; Beaumont & Sofronoff, 2008) 2. The child reported: 2.1. Emotion Regulation Questionnaire Child (ERQ-C; Gullone, Eleonora, & Taffe, 2011) 2.2. The Childrens Emotion Management Scales (CEM; Zeman, Shipman, & Penza-Clyve, 2001; Zeman, Cassano, Suveg, & Shipman, 2010), All primary parent and child measures will be collected at the following time points for the treatment Immediate group: baseline (Time 1), post intervention (Time 2) and follow-up (10 weeks post intervention). For the waitlist control group, data will be collected at baseline (Time 1), 10 weeks later (Time 2), post intervention (Time 3) and 10-weeks post intervention (Time 4). Previous primary outcome measures: Parent and child reports of emotion regulation skills, as measured by: 1. The parent reported: 1.1. Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997) 1.2. Emotion Regulation and Social Skills Questionnaire - Parent (ERSSQ-P; Beaumont & Sofronoff, 2008) 2. The child reported: 2.1. Emotion Regulation Questionnaire Child (ERQ-C; Gullone, Eleonora, & Taffe, 2011) 2.2. The Childrens Emotion Management Scales (CEM; Zeman, Shipman, & Penza-Clyve, 2001; Zeman, Cassano, Suveg, & Shipman, 2010), 3. A parent-child Child Emotional Reactivity and Emotional Regulation Strategies Task (Melnick & Hinshaw, 2000). All primary parent and child measures will be collected at the following time points: Baseline (Time 1), 10-weeks post Baseline (Time 2), 20-weeks post Baseline (Time 3) |
| Secondary outcome measures | Current secondary outcome measures as of 01/02/2016: 1. Parent reports of child psychopathology (BASC-2; Reynolds & Kamphaus, 2006) and social skills 2. Parenting competence and psychopathology 3. Direct testing of childrens cognitive flexibility (Emotional Stroop Task: Smith & Waterman, 2003; and CogState-Set Shifting Task) 4. Physiological arousal (electrodermal response) 5. Social-emotional awareness (CogState-Social Emotional Task) 6. Problem solving in social situations (James and the Math Test: Atwood, 2004; and Dylan is Being Teased: Atwood, 2004) All secondary parent and child measures will be collected at the following time points for the treatment Immediate group: baseline (Time 1), post intervention (Time 2) and follow-up (10 weeks post intervention). For the Waitlist control group, data will be collected at baseline (Time 1), 10 weeks later (Time 2), post intervention (Time 3) and 10-weeks post intervention (Time 4). Previous secondary outcome measures: 1. Parent reports of child psychopathology (BASC-2; Reynolds & Kamphaus, 2006) and social skills 2. Parenting competence and psychopathology 3. Direct testing of childrens cognitive flexibility (Emotional Stroop Task: Smith & Waterman, 2003; and CogState-Set Shifting Task) 4. Physiological arousal (electrodermal response) 5. Social-emotional awareness (CogState-Social Emotional Task) 6. Problem solving in social situations (James and the Math Test: Atwood, 2004; and Dylan is Being Teased: Atwood, 2004) All secondary parent and child measures will be collected at the following time points: Baseline (Time 1), 10-weeks post Baseline (Time 2), 20-weeks post Baseline (Time 3) |
| Overall study start date | 01/10/2013 |
| Overall study end date | 17/02/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 68 |
| Participant inclusion criteria | 1. Age: 8-12 years 2. Diagnosis of High Functioning Autism Spectrum Disorder or Aspergers syndrome 3. Average language skills |
| Participant exclusion criteria | Participants cannot be involved in another emotion regulation program |
| Recruitment start date | 01/10/2013 |
| Recruitment end date | 14/04/2016 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto
M3J 1P3
Canada
Sponsor information
University/education
c/o Dr Jonathan Weiss
4700 Keele Street
230 Behavioural Sciences Building
Toronto
M3J 1P3
Canada
| jonweiss@yorku.ca | |
"ROR" |
https://ror.org/05fq50484 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/04/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2018 | Yes | No |
Editorial Notes
11/05/2018: Internal review.
26/04/2018: Publication reference added.
26/05/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/05/2017 to 14/04/2016.
2. The overall trial end date was changed from 01/09/2017 to 17/02/2017.
3. The target number of participants was changed from 40 to 68.
01/02/2016: The overall trial end date was changed from 30/09/2015 to 01/09/2017.
