Condition category
Mental and Behavioural Disorders
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
17/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Helen McConachie

ORCID ID

Contact details

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

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 Children’s 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. Children’s Automatic Thoughts Scale (baseline and 3 months)
4. Children’s 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

http://www.ntw.nhs.uk

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

  1. 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.

Additional files

Editorial Notes