The Secret Agent Society: Operation Regulation intervention - transdiagnostic trial
| ISRCTN | ISRCTN14052478 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14052478 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/05/2017
- Registration date
- 30/05/2017
- Last edited
- 02/10/2024
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Neurodevelopmental disorders (NDD) are impairments of the growth and development of the brain or central nervous system. Youth with NDD often struggle with anxiety, depression or anger as a result of difficulties controlling their emotions. There are a number of cognitive behavioural interventions that are designed to address factors related to anxiety in youth with NDD, 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 NDD build these skills. The Secret Agent Society is a cognitive behavioural 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, including emotion-focused computer games, code cards, in-session games, and parent and teacher handouts, are used to engage youth with NDD in developing skills to help cope with their emotions and better handle day-to-day stress.
Who can participate?
Children between 8 and 13 years of age with a neurodevelopmental disorder (autism spectrum disorder, fetal alcohol spectrum disorder, cerebral palsy, learning disability, or attention deficit hyperactivity disorder). Children need to have at least average language skills, an IQ of 80 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 12 weeks before receiving the 10-week intervention. The intervention is provided individually to the children.
What are the 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 children’s levels of negative emotions and improvement in social skills. Participants may also benefit from the attention and support provided by the therapist through weekly one-on-one therapy sessions. Risks to participating 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 their child’s experience of distressing feelings (e.g., anger, frustration, sadness). Many children with NDD have already completed this 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 child’s 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 study starting and how long is it expected to run for?
September 2016 to March 2023
Who is funding the study?
Canadian Institutes of Health Research (Canada)
Who is the main contact?
Paula Tablon
tablonp@yorku.ca
Contact information
Scientific
4700 Keele Street
250 Behavioural Sciences Building
Toronto
M3J 1P3
Canada
| Phone | +1 (0)416 736 2100 ext. 22987 |
|---|---|
| tablonp@yorku.ca |
Study information
| Study design | Five-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 tablonp@yorku.ca to request a patient information sheet |
| Scientific title | Cognitive behaviour therapy for mental health problems in children with neurodevelopmental disorders: a transdiagnostic approach |
| Study acronym | SAS:OR NDD |
| Study objectives | Treatment group participants will show significant improvements in emotional regulation skills compared to those in the waitlist control group. |
| Ethics approval(s) | Approved 01/09/2016, Research Ethics Board (York University, Toronto, M3J1P3, Canada; +1 (0)4167362100; jonweiss@yorku.ca), ref: e2016-287 |
| Health condition(s) or problem(s) studied | Neurodevelopmental disorders (autism spectrum disorders, fetal alcohol spectrum disorder, cerebral palsy, learning disability, or attention deficit hyperactivity disorder) |
| Intervention | Random assignment will occur after baseline assessment is complete. Once participants are deemed eligible for the study (following in-person screening) they are randomized to treatment immediately or waitlist control condition using a randomly generated list obtained from the following site: https://www.randomizer.org/ 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 will be assigned to the waitlist control condition (asked to wait 12 weeks before receiving the intervention). The program involves ten 1-hour weekly sessions, where the youth and a parent will meet with a therapist for one-on-one therapy. During these sessions, the youth will participate in an assortment of activities including computer games, problem solving tasks, role playing, and working with their parent and therapist. They also will get some brief homework tasks to help generalize what they are learning. The focus of all of these activities is to help build emotion regulation skills. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Child mental health problems: 1.1. Emotional disorders, measured using the Anxiety Disorders Interview Schedule: Child and Parent Interview-4th Edition (ADIS-C/P-IV) 1.3. Child behaviour and emotions, measured using the Behavior Assessment System for Children, Third Edition (BASC-3) 1.2. Child illness severity, global improvement/change and therapeutic response, measured using the Clinical Global Impression–Severity and –Improvement (CGI-Severity, CGI-Improvement) All measures will be collected at the following time points for the treatment immediate group: baseline (Time 1), 12 weeks post baseline (Time 2) and follow-up (12-weeks post Time 2). For the waitlist control group, data will be collected at baseline (Time 1), 12 weeks later (Time 2), post intervention (Time 3) and 12-weeks post intervention (Time 4). With the exception of WRAT-4, which will only be completed at Time 1. |
| Secondary outcome measures | Current secondary outcome measures as of 23/07/2019: Child Report Measures: 1. Child emotion regulation, measured using the Children’s Emotion Management Scales (CEMS) 2. Child acceptance and mindfulness, measured using the Child & Adolescent Mindfulness Measure (CAMM) 3. Child social problem-solving, measured using James and the Math Test and Dylan is Being Teased 4. Child emotion regulation, measured using the Computerized Mirror Tracing Performance Task (2013) 5. Direct testing of children's cognitive flexibility using CogState (Set-Shifting Task) and the NIH Toolkit (Dimensional Change Card Sorting (DCCS) Task and the Flanker Test) 6. Child physiological arousal, measured using electrodermal response 7. Child therapeutic alliance, measured using Child Session Rating Scale (CSRS) 8. Child functioning, measured using Child Outcome Rating Scale (CORS) Parent Report Measures: 1. Parents’ expressed emotion, measured using the Five Minute Speech Sample (FMSS) 2. Child emotion regulation, measured using the Emotion Regulation Checklist (ERC) 3. Child emotion regulation and social skills, measured using the Emotion Regulation and Social Skills Questionnaire - Parent (ERSSQ-P) 4. Quality of the parent-child relationship, measured using the Positive Affect Index (PAI) 5. Child adjustment and psychopathology, measured using the Strength and Difficulties Questionnaire (SDQ) 6. Child health-related quality of life, measured using KIDSCREEN 7. Parent distress, measured using the Depression, Anxiety and Stress Scale (DASS-21) 8. Parent physiological arousal, measured using electrodermal response 9. Child emotion dysregulation, measured using the Emotion Dysregulation Inventory (EDI) 10. Child service assessment, measured using the Service Assessment of Children and Adolescents (SACA) 11. Parent functioning, measured using the Outcome Rating Scale (ORS) 12. Parent therapeutic alliance, measured using the Session Rating Scale (SRS) Parent Child Dyad: 1. Parent and child emotion regulation and socialization, measured using the Emotion Discussion Task (EDT) All measures will be collected at the following time points for the treatment immediate group: baseline (Time 1), 12 weeks post baseline (Time 2) and follow-up (12-weeks post Time 2). For the waitlist control group, data will be collected at baseline (Time 1), 12 weeks later (Time 2), post intervention (Time 3) and 12-weeks post intervention (Time 4). With the exception of WRAT-4, which will only be completed at Time 1. Previous secondary outcome measures: Child Report Measures: 1. Child emotion regulation, measured using the Children’s Emotion Management Scales (CEMS) 2. Child acceptance and mindfulness, measured using the Child & Adolescent Mindfulness Measure (CAMM) 3. Child social problem-solving, measured using James and the Math Test and Dylan is Being Teased 4. Child emotion regulation, measured using the Computerized Mirror Tracing Performance Task (2013) Parent Report Measures: 1. Parents’ expressed emotion, measured using the Five Minute Speech Sample (FMSS) 2. Child emotion regulation, measured using the Emotion Regulation Checklist (ERC) 3. Child emotion regulation and social skills, measured using the Emotion Regulation and Social Skills Questionnaire - Parent (ERSSQ-P) 4. Quality of the parent-child relationship, measured using the Positive Affect Index (PAI) 5. Child adjustment and psychopathology, measured using the Strength and Difficulties Questionnaire (SDQ) 6. Child health-related quality of life, measured using KIDSCREEN Parent Child Dyad: 1. Parent and child emotion regulation and socialization, measured using the Emotion Discussion Task (EDT) All measures will be collected at the following time points for the treatment immediate group: baseline (Time 1), 12 weeks post baseline (Time 2) and follow-up (12-weeks post Time 2). For the waitlist control group, data will be collected at baseline (Time 1), 12 weeks later (Time 2), post intervention (Time 3) and 12-weeks post intervention (Time 4). With the exception of WRAT-4, which will only be completed at Time 1. |
| Overall study start date | 01/09/2016 |
| Completion date | 31/03/2023 |
| Reason abandoned (if study stopped) | COVID-19 pandemic |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Age 8-13 years 2. Diagnosis of a neurodevelopmental disorder (autism spectrum disorder, fetal alcohol spectrum disorder, cerebral palsy, learning disability, or attention deficit hyperactivity disorder) 3. FSIQ > 80 (WASI-II; Weschler, 2011) 4. At least one co-occurring anxiety or mood disorder |
| Key exclusion criteria | 1. Participants cannot be involved in another emotion regulation program within a 12-month period of participating in SAS-OR 2. Presence of a psychotic disorder, or aggressive/self-injurious behaviours that pose a safety risk |
| Date of first enrolment | 17/04/2017 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto
M3J 1P3
Canada
Sponsor information
University/education
4700 Keele Street
230 Behavioural Sciences Building
Toronto
M3J 1P3
Canada
| Phone | +1 (0)416 736 2100 ext. 55891 |
|---|---|
| jonweiss@yorku.ca | |
| Website | http://asdmentalhealth.ca/ |
"ROR" |
https://ror.org/05fq50484 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | 01/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
Editorial Notes
02/10/2024: The study was stopped prematurely as a result of the COVID-19 pandemic. Ethics approval details added.
19/04/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2021 to 31/01/2023.
2. The overall trial end date was changed from 26/12/2021 to 31/03/2023.
3. The intention to publish date was changed from 01/07/2022 to 01/07/2023.
04/05/2020: Due to current public health guidance, recruitment for this study has been paused.
23/07/2019: The following changes have been made:
1. The overall trial end date has been changed from 30/09/2021 to 26/12/2021.
2. The intention to publish date has been changed from 09/01/2022 to 01/07/2022.
3. The secondary outcome measures have been changed.
