Anxiety problems in autistic children aged 5-12 Mental and Behavioural Disorders
Conditions
Interventions
This is a two-arm, multi-site, randomised controlled non-inferiority trial, with a nested pilot trial, to evaluate the clinical and cost-effectiveness of a brief parent-led cognitive behavioural treat
confirmed autistic) is balanced across the two groups. Participating families will be randomised to either OSI-A with therapist support or to usual treatment within child mental health services to est
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: Child 1. Is aged 5-12 years at the time of parental consent 2. Autism diagnosis or positive screen on autism questionnaire (SCQ) 3. The primary problem is anxiety Parent/Carer: 1. Is the parent/carer of a child who meets the study inclusion criteria 2. Has sufficient English language, or available assistance, to complete measures/ access interventions 3. Has access to the internet (NB. Devices and financial support for data access can be made available). 4. Is willing and able to provide consent. Therapists (for qualitative interviews only) 1. Provides psychological treatment to children in participating services 2. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: Child 1. Has co-morbid conditions that mean therapeutic strategies are clinically inappropriate (diagnosed profound or severe intellectual disability, suicidal intent/ recurrent or potentially life-limiting self-harm), 2. Is identified by social services due to child protection concerns. Parent/carer 1. Has been diagnosed with a profound or severe intellectual disability or severe mental health problem that is likely to interfere with treatment delivery. Therapist There are no exclusion criteria for Therapists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness is measured using the Child Anxiety Impact Scale- Parent Report (CAIS-P) at 48 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical effectiveness is measured using the following child-reported tools at 24 weeks post-randomisation: 1.1. Child Anxiety Impact Scale (CAIS-C) 1.2. Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD) 2. Clinical effectiveness is measured using the following tools at 48 weeks post-randomisation: 2.1. Parent-reported Child Anxiety Impact Scale (CAIS-P) 2.2. Parent-reported Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD -P) 2.3. Parent-reported Outcome Rating Scale (ORS) 2.4. Common comorbid emotional and behavioural problems Strengths and Difficulties Questionnaire (SDQ) 2.5. Child- and parent-reported progress against valued outcomes using bespoke Likert scales 2.6. Parent confidence and skills to apply treatment strategies using bespoke Likert scales 3. Cost-effectiveness is measured using the Child Quality Adjusted Life Years (QALYs) derived from the CHU-9D proxy version, i.e. parent -report on child, at baseline, 24 weeks post-randomisation and 48 weeks post-randomisation | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactCathy Creswell
Outcome results
None listed