Skip to content

The Secret Agent Society: Operation Regulation intervention - transdiagnostic trial

Cognitive behaviour therapy for mental health problems in children with neurodevelopmental disorders: a transdiagnostic approach

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14052478
Enrollment
100
Registered
2017-05-30
Start date
2017-04-17
Completion date
Unknown
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodevelopmental disorders (autism spectrum disorders, fetal alcohol spectrum disorder, cerebral palsy, learning disability, or attention deficit hyperactivity disorder) Mental and Behavioural Disorders

Interventions

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

Sponsors

York University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026