Intolerance of uncertainty in children with autism spectrum disorder: a feasibility trial
| ISRCTN | ISRCTN10139240 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10139240 |
| Secondary identifying numbers | 38104 |
- Submission date
- 30/04/2018
- Registration date
- 14/05/2018
- Last edited
- 06/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 June 2020
Who is funding the study?
Autistica (UK)
Who is the main contact?
Dr Jacqui Rodgers
jacqui.rodgers@ncl.ac.uk
Contact information
Scientific
Institute of Neuroscience
Sir James Spence Institute
Newcastle University
Royal Victoria Infirmary
Queen Victoria Road
Newcastle
NE1 4LP
United Kingdom
 ORCID ID |
0000-0002-1759-316X |
|---|---|
| Phone | +44 (0)191 282 0676 |
| jacqui.rodgers@ncl.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Psychological & Behavioural |
|---|---|
| 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 use the contact details to request a patient information sheet |
| Scientific title | Addressing intolerance of uncertainty in children with autism spectrum disorder: an intervention feasibility trial |
| 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(s) | North East – Tyne & Wear South Research Ethics Committee, 17/04/2018, ref: 18/NE/0106 |
| Condition | Autism spectrum disorder |
| 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 |
| 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 study start date | 03/01/2018 |
| Overall study end date | 30/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Total final enrolment | 53 |
| 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 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 | 21/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Walkergate Park
Benfield Road
Newcastle
NE6 4QD
United Kingdom
Albion Road Clinic
Albion Road
North Shields
NE29 0HG
United Kingdom
Sponsor information
Hospital/treatment centre
St. Nicholas Hospital
Jubilee Road
Gosforth
NEWCASTLE UPON TYNE
NE3 3XT
England
United Kingdom
| Phone | +44 (0)191 246 7222 |
|---|---|
| Lyndsey.Dixon@ntw.nhs.uk | |
"ROR" |
https://ror.org/01ajv0n48 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the small sample size and potentially identifiable nature of the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/06/2019 | 01/07/2019 | Yes | No |
| Results article | 05/07/2022 | 06/07/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/07/2022: Publication reference added.
04/07/2022: IPD sharing statement added.
02/06/2021: The intention to publish date was changed from 30/06/2021 to 30/06/2022.
08/06/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/05/2020 to 30/06/2020.
2. The intention to publish date was changed from 31/05/2021 to 30/06/2021.
08/10/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 16/09/2019 to 21/06/2019.
2. The overall trial end date was changed from 31/05/2020 to 31/05/2020.
3. The total final enrolment number was added.
01/07/2019: Publication reference added.
23/05/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2019 to 16/09/2019.
2. The overall end date was changed from 31/12/2019 to 31/05/2020.
3. The intention to publish date was changed from 31/12/2020 to 31/05/2021.
4. The plain English summary was updated to reflect these changes.
22/03/2019: The condition was updated from "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" to "Autism spectrum disorder".
08/01/2019: The recruitment end date has been updated from 31/12/2018 to 30/04/2019.
15/05/2018: Internal review.
