Condition category
Mental and Behavioural Disorders
Date applied
30/04/2018
Date assigned
14/05/2018
Last edited
15/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Anxiety causes difficulties for around 50% of children with autism spectrum disorder (ASD); childhood anxiety is a major risk factor for anxiety in adulthood. Research shows that anxiety can be caused by uncertainty, leading to Intolerance of uncertainty (IU). People who experience IU believe that uncertainty is stressful and upsetting and should be avoided. IU has an important role in the development and maintenance of anxiety and is a barrier to effective anxiety treatment. Despite this, there are no existing therapies that target IU for children with ASD. The aim of this study is to find out whether a parent-based intervention can assist children with ASD to manage uncertain situations more effectively.

Who can participate?
Parents of children aged 6-16 with ASD and anxiety

What does the study involve?
Families are randomly allocated to either receive the uncertainty intervention or attend a parent group. The uncertainty intervention is run by trained NHS therapists. The researchers meet with families individually at the start of the study to gather information about their child's IU and anxiety. Parents receiving the uncertainty intervention attend an eight-week programme alongside other parents. Parents from the intervention groups are asked to identify a target situation that involves uncertainty through which they practise the strategies learned with their child. The researchers meet with the families individually at the end of the programme and a few months later to find out how acceptable and helpful the intervention was.

What are the possible benefits and risks of participating?
People who take part in this study are given an opportunity to contribute to research which will help to improve the understanding of ASD and anxiety. It is thought that the disadvantages or risks of participating in this study are minimal. The questionnaires ask about everyday behaviours so it is not anticipated that this will cause any problems. All travel expenses for attending sessions will be reimbursed. It might be distressing for parents to discuss their child’s feelings and reactions. If this happens, the researchers will be available to support them and to signpost to other local services for help where appropriate.

Where is the study run from?
1. Northumberland, Tyne and Wear NHS Foundation Trust (UK)
2. Northumbria Healthcare NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2018 to December 2019

Who is funding the study?
Autistica (UK)

Who is the main contact?
Dr Jacqui Rodgers
jacqui.rodgers@ncl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jacqui Rodgers

ORCID ID

http://orcid.org/0000-0002-1759-316X

Contact details

Institute of Neuroscience
Sir James Spence Institute
Newcastle University
Royal Victoria Infirmary
Queen Victoria Road
Newcastle
NE1 4LP
United Kingdom
+44 (0)191 282 0676
jacqui.rodgers@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

38104

Study information

Scientific title

Addressing intolerance of uncertainty in children with autism spectrum disorder: an intervention feasibility trial

Acronym

Study hypothesis

Anxiety causes difficulties for around 50% of children with autism spectrum disorder (ASD); childhood anxiety is a major risk factor for anxiety in adulthood. Research shows that anxiety can be caused by uncertainty, leading to Intolerance of uncertainty (IU). People who experience IU believe that uncertainty is stressful and upsetting and should be avoided. IU has an important role in the development and maintenance of anxiety and is a barrier to effective anxiety treatment. Despite this, there are no existing therapies that target IU for children with ASD. During the therapy development study, clinicians and parents worked together to develop a parent-based intervention to assist children with ASD to manage uncertain situations more effectively. The intervention was delivered to parents of young people with ASD in a small group setting. During eight two-hour sessions parents were given strategies to assist their child with uncertainty in everyday situations. Parents learned to identify when their child was showing anxiety related to uncertainty and to practice strategies to enable them to tolerate uncertainty.

Ethics approval

North East – Tyne & Wear South Research Ethics Committee, 17/04/2018, ref: 18/NE/0106

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural

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 use the contact details to request a patient information sheet

Condition

Specialty: Mental Health, Primary sub-specialty: Developmental disorders - Autism; UKCRC code/ Disease: Mental health/ Disorders of psychological development, Mental health/ Neurotic, stress-related and somatoform disorders

Intervention

Sixty parents of children with ASD and anxiety are recruited from NHS services. Randomisation will occur through the online service ‘Sealed Envelope’ (https://www.sealedenvelope.com/). Families will be randomised to the CUES group (intervention group: A) or the Understanding Autism group (enhanced services as usual group: B) and the result recorded. Randomisation will be blocked (using random permuted blocks) to ensure that the groups are balanced. There is a single password for a trial and anyone with the password may carry out new randomisations for that trial. This will be done by the RA (Jane Goodwin), although the chief investigator (Dr Jacqui Rodgers) will have access for monitoring. The randomisation results will be shown on-screen and emailed to both the administrator of the trial and to the randomiser.

The uncertainty intervention group will be run by trained NHS therapists. The trialists will meet with families individually at the start to gather information about their child's IU and anxiety. Parents receiving the intervention will attend the eight-week programme alongside other parents. Parents from the intervention groups are asked to identify a target situation that involves uncertainty through which they will practise the strategies learned with their child. The trialists will meet with the families individually at the end of the programme and a few months later to find out how acceptable and helpful the intervention was. The follow ups take place immediately post-treatment (or equivalent for Understanding Autism group), at 12 weeks and 26 weeks post-treatment (or equivalent).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Intolerance of uncertainty is measured using target behaviour rating of target situations at baseline, immediately post treatment (or equivalent for Understanding Autism), 12 weeks and 26 weeks post treatment

Secondary outcome measures

1. Children’s intolerance of uncertainty (parent and child reported) is measured using the Intolerance of Uncertainty Scale (IUS – P &C, Walker, 2009) at baseline, immediately post treatment (or equivalent for Understanding Autism), 12 weeks and 26 weeks post treatment
2. Children’s anxiety is measured using the Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher et al., 1997) at baseline, immediately post treatment (or equivalent for Understanding Autism), 12 weeks and 26 weeks post treatment
3. Children’s anxiety (parent and child reported) is measured using the Anxiety Scale for Children - ASD (ASC-ASD, Rodgers et al., 2016) at baseline, immediately post treatment (or equivalent for Understanding Autism), 12 weeks and 26 weeks post treatment
4. Children’s activities and participation are measured using the Children’s Assessment of Participation and Enjoyment (CAPE, King et al., 2004) at baseline, immediately post treatment (or equivalent for Understanding Autism), 12 weeks and 26 weeks post treatment
5. Parents’ self-efficacy is measured using the Parent Self-efficacy scale (Sofronoff & Farbotko, 2002) at baseline, immediately post treatment (or equivalent for Understanding Autism), 12 weeks and 26 weeks post treatment
6. Parents’ own intolerance of uncertainty is measured using the Intolerance of Uncertainty Scale (IUS-12; Carleton, 2012) at baseline, immediately post treatment (or equivalent for Understanding Autism), 12 weeks and 26 weeks post treatment
7. Parents’ mental wellbeing is measured using the Depression, Anxiety and Stress Scale (DASS, Lovibond & Lovibond, 1995) at baseline, immediately post treatment (or equivalent for Understanding Autism), 12 weeks and 26 weeks post treatment
8. Treatment expectancy is measured using the Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000) at baseline, immediately post treatment (or equivalent for Understanding Autism), 12 weeks and 26 weeks post treatment

Overall trial start date

03/01/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Parents of autistic children who:
1.1. Are aged 6-16 years
1.2. Experience some anxiety
1.3. Do not have intellectual disability OR have mild to moderate intellectual disability
1.4. Have sufficient language ability to complete appropriate outcome measures (with assistance if required)
2. Parents/carers have sufficient spoken and written English to provide written informed consent, complete assessments and participate in the intervention

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Children who experience severe and complex anxiety disorder
2. Children with severe intellectual disability
3. Children with complex health conditions
4. Parents with significant mental health difficulties

Recruitment start date

15/05/2018

Recruitment end date

31/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Complex Neurodevelopmental Disorders Service (CNDS)
Northumberland, Tyne and Wear NHS Foundation Trust Walkergate Park Benfield Road
Newcastle
NE6 4QD
United Kingdom

Trial participating centre

Child and Adolescent Mental Health service (CAMHS)
Northumbria Healthcare NHS Foundation Trust Albion Road Clinic Albion Road
North Shields
NE29 0HG
United Kingdom

Sponsor information

Organisation

Northumberland, Tyne and Wear NHS Foundation Trust

Sponsor details

St. Nicholas Hospital
Jubilee Road
Gosforth
NEWCASTLE UPON TYNE
NE3 3XT
United Kingdom
+44 (0)191 246 7222
Lyndsey.Dixon@ntw.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Autistica; Grant Codes: 7520

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A protocol paper is under preparation and will be available once completed. The trialists plan to publish the results in a high-impact peer reviewed journal.

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

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/05/2018: Internal review.