Secret Agent Society (a virtual small group cognitive behaviour program for autistic children during the pandemic) proof of concept study
| ISRCTN | ISRCTN98068608 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98068608 |
| Secondary identifying numbers | e2020-080 |
- Submission date
- 07/09/2023
- Registration date
- 15/09/2023
- Last edited
- 31/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Emotion regulation, social challenges, and mental health problems are concerns that impact the wellbeing of children with autism. Outside of the COVID-19 pandemic, 40-70% are estimated to have significant emotional and behavioural problems, such as anxiety, depression, or anger (Simonoff et al., 2008). Supports can include using adapted behavioural interventions including The Secret Agent Society: Small Group Program (SAS:SG; Beaumont, 2016) in controlled settings. However, there is a limited understanding of how effective evidence-based programs focused on emotion regulation and social skills are under real world, ecologically valid conditions where autistic children and youth receive most of their services, especially within the context of a pandemic.
Who can participate in the study?
Autistic children between the ages of 8-12 years and their caregivers. Children should be verbally able and do not have a history of self-injurious behaviour. Children should have noted challenges in emotion regulation and social skills.
What does the study involve?
Children and their caregivers will be invited to participate in a 10-week socioemotional-focused program called the Secret Agent Society Small Group (SAS:SG) program. All families will be enrolled in the program and there are no control groups. The program will be led by SAS:SG therapist and delivery virtually. Children and caregivers will participate in separate groups (60-90 mins each) on a weekly basis. Parents will be asked to complete online questionnaires before and after the 10-week program program, and 3-months after finishing the program. Parents will also be asked to participate in focus groups to talk about their family's experience participating in the program.
What are the possible benefits and risks of participating?
Given that this therapy has been shown to improve social skills and emotion regulation in children, participation in the program may result in a reduction of your child’s levels of negative emotions and improve in their social skills. Participants may also benefit from the support provided by the clinical team through the sessions. Risks to the participate may include fatigue related to the completion of questionnaires, as well as feelings of discomfort generated by the content of the questions asked, for instance, questions relating to their child’s experience of distressing feelings (e.g., anger, worry, sadness).
Where is the study run from?
York University, Toronto, Ontario, Canada.
When is the study starting and how long is it expected to run for?
December 2019 to December 2021
Who is funding the study?
Kids Brain Health Network (Canada).
Who is the main contact?
Dr. Vivian Lee,vivian.lee4@carleton.ca
Contact information
Principal Investigator
1125 Colonel By Drive.
Carleton University-Loeb B505
Ottawa
K1S 5B6
Canada
 ORCID ID |
0000-0002-8686-6264 |
|---|---|
| Phone | +1 6478088115 |
| vivian.lee4@carleton.ca |
Study information
| Study design | Multicentre interventional feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Internet/virtual |
| Study type | Other, Treatment, Efficacy |
| Scientific title | Utility of a virtual small group cognitive behaviour program for autistic children during the pandemic: evidence from a community-based implementation study |
| Study acronym | CSAS |
| Study hypothesis | The study was conducted to explore the feasibility and clinical utility of implementing the Secret Agent Society: Small Group Program for autistic children as delivered by Canadian community-based autism services and programs during the pandemic. |
| Ethics approval(s) |
Approved 16/03/2020, York University Office of Research Ethics (4700 Keele Street. 309 York Lanes, Toronto, M3J1P3, Canada; +1 416-736-5914; ore@yorku.ca), ref: e2020-080 |
| Condition | Improving emotion regulation and social skills in children with autism |
| Intervention | Participants are recruited by community-based autism service providers. There is no randomization and all participants receive the intervention. All participants (children and their caregivers) are enrolled in a 10-week virtually delivered socioemotional behavioural intervention called the Secret Agent Society Small Group (SAS:SG) program and receive a 3-month follow-up session. Child and parent groups meet separately once a week for 60-90 minutes on a virtual platform. All groups are led by trained SAS:SG therapists. |
| Intervention type | Behavioural |
| Primary outcome measure | Child emotion regulation and social skills are measured using parent-report online questionnaires at baseline, post-intervention, and 3-months post-intervention. |
| Secondary outcome measures | 1. Program satisfaction measured using parent-report online questionnaires post-intervention, and 3-months post-intervention 2. Intervention acceptability measured using parent-report online questionnaires post-intervention, and 3-months post-intervention. |
| Overall study start date | 01/12/2019 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient, Carer |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 96 |
| Total final enrolment | 88 |
| Participant inclusion criteria | 1. Official autism diagnosis by a healthcare professional 2. Between 8-12 years old 3. Verbally able to participate 4. Family had access to technology (e.g., high speed internet, technology) at home 5. Parent was available to participate in weekly parent groups |
| Participant exclusion criteria | 1. No intellectual disability 2. No history of self-harm behaviours |
| Recruitment start date | 01/09/2020 |
| Recruitment end date | 09/01/2021 |
Locations
Countries of recruitment
- Canada
Study participating centres
Aurora
L4G 1W9
Canada
Toronto
M4S 3A8
Canada
Oshawa
L1G 4X8
Canada
Burlington
L7P 0T3
Canada
Hamilton
L8L 0A4
Canada
Whitby
L1N 6A9
Canada
Toronto
M5S 2C2
Canada
Sponsor information
Research organisation
Simon Fraser University
Discovery 2 - Room 204
8900 Nelson Way
Burnaby
V5A 4W9
Canada
| Phone | +1 778-782-7283 |
|---|---|
| admin@kidsbrainhealth.ca | |
| Website | https://kidsbrainhealth.ca/ |
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Réseau pour la santé du cerveau des enfants, KBHN
- Location
- Canada
Results and Publications
| Intention to publish date | 01/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in high-impact journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the stipulations outlined in or data sharing agreements with each of the community-based providers, and the fact that participants did not consent to having their de-identified data shared outside of the research team. Due to the potentially identifiable data the dataset will not be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/05/2024 | 31/05/2024 | Yes | No |
Editorial Notes
31/05/2024: Publication reference added.
11/09/2023: Trial's existence confirmed by York University.
