Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6868
Study information
Scientific title
Effective therapy for anxiety in young people with autism spectrum disorder: a pilot randomised treatment trial
Acronym
BAT (Beating Anxiety Together)
Study hypothesis
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
South Yorkshire Research Ethics committee approved on the 21/07/2009 (ref: 09/H1310/44)
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
09/10/2009
Overall trial end date
30/09/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned sample size: 36; UK sample size: 36
Participant exclusion criteria
Children with severe conduct or attention problems, or oppositional behaviour, because of likely disruption to the group process.
Recruitment start date
09/10/2009
Recruitment end date
30/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Health and Society
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
Northumberland, Tyne and Wear NHS Trust (UK)
Sponsor details
St Nicholas Hospital
Jubilee Road
Gosforth
Newcastle Upon Tyne
NE3 3XT
United Kingdom
ali.zaatar@ntw.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
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
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24101715
Publication citations
-
Results
McConachie H, McLaughlin E, Grahame V, Taylor H, Honey E, Tavernor L, Rodgers J, Freeston M, Hemm C, Steen N, Le Couteur A, Group therapy for anxiety in children with autism spectrum disorder., Autism, 2013, 18, 6, 723-732, doi: 10.1177/1362361313488839.