Condition category
Mental and Behavioural Disorders
Date applied
12/09/2013
Date assigned
16/10/2013
Last edited
01/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Youth with high functioning autism spectrum disorders (HFASD) often struggle with co-occurring 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, however 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. We will be using a variety of activities and tools, like an emotion focused computer game, cue cards, in session games, and parent and teacher handouts, 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?
The Secret Agent Society: Operation Regulation intervention will be compared to waitlist control. All participants will receive the same treatment (i.e. go through the intervention), however half of the participants will receive the treatment immediately and the other half will be put on a waitlist for 10 weeks before receiving the 10 week intervention. The intervention is provided individually to children.

What are the benefits and risks of participating?
Benefits: 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.
Risks: 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 your 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, however, 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, Toronto (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?
Carly Albaum
calbaum@yorku.ca

Trial website

http://ddmh.lab.yorku.ca/secret-agents-society/

Contact information

Type

Scientific

Primary contact

Ms Carly Albaum

ORCID ID

Contact details

4700 Keele Street
250 Behavioural Sciences Building
Toronto
M3J 1P3
Canada
-
calbaum@yorku.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The Secret Agent Society – Operation Regulation intervention: a randomized controlled trial

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

Regional Ethics Board (REB) approved: Certificate #e2013-229

Study design

Two-year randomized waitlist controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 Children’s 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 Children’s 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 children’s 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 children’s 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 trial start date

01/10/2013

Overall trial end date

01/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age: 8-12 years
2. Diagnosis of High Functioning Autism Spectrum Disorder or Asperger’s syndrome
3. Average language skills

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant exclusion criteria

Participants cannot be involved in another emotion regulation program

Recruitment start date

01/10/2013

Recruitment end date

01/05/2017

Locations

Countries of recruitment

Canada

Trial participating centre

York University
Toronto
M3J 1P3
Canada

Sponsor information

Organisation

York University (Canada)

Sponsor details

c/o Dr. Jonathan Weiss
4700 Keele Street
230 Behavioural Sciences Building
Toronto
M3J 1P3
Canada
-
jonweiss@yorku.ca

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Chair in Autism Spectrum Disorders Treatment and Care Research, funded by the Canadian Institutes of Health Research in partnership with Health Canada, Autism Speaks Canada, NeuroDevNet, the Sinneave Family Foundation, and the Canadian Autism Spectrum Disorders Alliance (#284208)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 01/02/2016 the overall trial end date was changed from 30/09/2015 to 01/09/2017.