Condition category
Mental and Behavioural Disorders
Date applied
26/05/2017
Date assigned
30/05/2017
Last edited
30/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 September 2021

Who is funding the study?
Canadian Institutes of Health Research (Canada)

Who is the main contact?
Paula Tablon
tablonp@yorku.ca

Trial website

http://ddmh.lab.yorku.ca/secret-agent-society-operation-regulation-transdiagnostic-trial/

Contact information

Type

Scientific

Primary contact

Ms Paula Tablon

ORCID ID

Contact details

4700 Keele Street
250 Behavioural Sciences Building
Toronto
M3J 1P3
Canada
+1 (0)416 736 2100 ext. 22987
tablonp@yorku.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

SAS:OR NDD

Study hypothesis

Treatment group participants will show significant improvements in emotional regulation skills compared to those in the waitlist control group.

Ethics approval

Regional Ethics Board (REB), 08/09/2016, ref: #e2016-287

Study design

Five-year randomized waitlist controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please contact tablonp@yorku.ca to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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

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 trial start date

01/09/2016

Overall trial end date

30/09/2021

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

17/04/2017

Recruitment end date

01/04/2021

Locations

Countries of recruitment

Canada

Trial participating centre

York University
4700 Keele Street
Toronto
M3J 1P3
Canada

Sponsor information

Organisation

York University

Sponsor details

4700 Keele Street
230 Behavioural Sciences Building
Toronto
M3J 1P3
Canada
+1 (0)416 736 2100 ext. 55891
jonweiss@yorku.ca

Sponsor type

University/education

Website

http://asdmentalhealth.ca/

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

09/01/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes