Effective Therapy for Anxiety in Young People with Autism Spectrum Disorder
| ISRCTN | ISRCTN11219568 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11219568 |
| Secondary identifying numbers | 6868 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 17/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Helen McConachie
Scientific
Scientific
Institute of Health and Society
Newcastle University
Sir James Spence Institute 3rd Floor
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Study information
| Study design | Single centre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effective therapy for anxiety in young people with autism spectrum disorder: a pilot randomised treatment trial |
| Study acronym | BAT (Beating Anxiety Together) |
| Study objectives | The main objective is to establish the acceptability, local suitability and likely variability in outcomes of an adapted group cognitive behavioural therapy (CBT) approach for young people with autism spectrum disorder (ASD) and anxiety disorder. Young people are randomly allocated to intervention or to waiting list control. It is hypothesised that there will be a greater reduction in levels of anxiety in the intervention group compared with control, and that a greater proportion will no longer meet criteria for an anxiety disorder after treatment. |
| Ethics approval(s) | South Yorkshire Research Ethics committee approved on the 21/07/2009 (ref: 09/H1310/44) |
| Health condition(s) or problem(s) studied | Topic: Mental Health Research Network; Subtopic: Anxiety, Autism spectrum disorders; Disease: Anxiety, Autism spectrum disorders |
| Intervention | Rehearsal pilot trial of a brief group treatment adapted for children with ASD. Cognitive behaviour therapy has been adapted to the cognitive profile of young people with ASD in a 7 session format published as 'Exploring Feelings', developed and evaluated in Australia. The focus of the group is to develop skills in young people to stop the build-up of anxiety which typically takes a remitting/relapsing course. Parallel group sessions for parents train them in skills to support their child. Follow-up length: 12 months Study entry: single randomisation only |
| Intervention type | Other |
| Primary outcome measure | 1. Anxiety disorders measured with the Anxiety Disorders Interview Schedule (baseline and 3 months) 2. Level of anxiety measured with Spence Childrens Anxiety Scale (parent, child) (baseline, 3, 6, 9 and 12 months) |
| Secondary outcome measures | 1. Parent management strategies measured by the Child Development Questionnaire - ASD adaptation (baseline and 3 months) 2. Parent anxiety measured by the Depression Anxiety and Stress Scales (baseline and 3 months) 3. Childrens Automatic Thoughts Scale (baseline and 3 months) 4. Childrens Assessment of Participation and Enjoyment (baseline, 3 and 12 months) |
| Overall study start date | 09/10/2009 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 9 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 36; UK sample size: 36 |
| Key inclusion criteria | 1. Children aged 9 - 13 years old, boys and girls 2. Diagnosis of autism, ASD or Asperger syndrome 3. Ability in the average range (Full Scale Intelligence Quotient [FSIQ] greater than 70) 4. Sufficient spoken English to take part in assessments 5. Meeting criteria for anxiety disorder (as assessed by research team) 6. Parent/carer and young person willing to attend group CBT |
| Key exclusion criteria | Children with severe conduct or attention problems, or oppositional behaviour, because of likely disruption to the group process. |
| Date of first enrolment | 09/10/2009 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Health and Society
Newcastle Upon Tyne
NE1 4LP
United Kingdom
NE1 4LP
United Kingdom
Sponsor information
Northumberland, Tyne and Wear NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
St Nicholas Hospital
Jubilee Road
Gosforth
Newcastle Upon Tyne
NE3 3XT
England
United Kingdom
| ali.zaatar@ntw.nhs.uk | |
| Website | http://www.ntw.nhs.uk |
"ROR" |
https://ror.org/01ajv0n48 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2014 | Yes | No |
