Plain English Summary
Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a common disorder that affects behaviour. ADHD can present in a number of ways, but common symptoms include a short attention span, restlessness, hyperactivity and impulsiveness. It has been found that up to half of children with a diagnosis of ADHD also have problems with anxiety. The exact reason for this is unknown, but it may be because the symptoms of ADHD are very disruptive to daily life and can make life a lot more stressful. As well as affecting the children’s quality of life, it has been found that their parents are more likely to suffer from mental health difficulties, such as anxiety and depression. There is a lot of evidence to suggest that anxiety problems in children with ADHD may be underreported, as the symptoms of anxiety can be very similar to the ADHD symptoms. This can mean that many children are not treated, and their anxiety problems can get even worse. There are many ways to treat anxiety; however behavioural treatments such as cognitive behavioural therapy (CBT) may be preferable to medication for the children’s parents. The aim of this study is to find out how effective a CBT programme, designed to help children to cope better with their anxiety, is for children suffering from ADHD.
Who can participate?
Children aged 8 to 12 years with a diagnosis of ADHD, who show signs of anxiety.
What does the study involve?
Participants are randomly allocated into the treatment group, or the usual care group. Those in the treatment group attend 10 sessions with a clinician to learn strategies to help them to manage their feelings of anxiety. Those in the usual care group receive access to usual care for their ADHD, but no extra help with their feelings of anxiety. After five months, the parents and teachers complete questionnaires about the children’s feelings of anxiety and behaviour. The wellbeing and behaviour of the parents are also assessed using questionnaires at this timepoint.
What are the possible benefits and risks of participating?
Benefits of participating may include an improvement in anxiety, which could lead to improvements in the child’s behaviour and wellbeing. There are no risks of participating in the study.
Where is the study run from?
Murdoch Childrens Research Institute (Australia)
When is the study starting and how long is it expected to run for?
September 2015 to December 2019
Who is funding the study?
1. Murdoch Childrens Research Institute (Australia)
2. Sidney Myer Fund and Myer Foundation (Australia)
3. The National Health and Medical Research Council (Australia)
Who is the main contact?
Dr Emma Sciberras
emma.sciberras@deakin.edu.au
Trial website
Contact information
Type
Scientific
Primary contact
Dr Emma Sciberras
ORCID ID
Contact details
Centre for Community Child Health
The Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia
+61 39251 7222
emma.sciberras@deakin.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Does the treatment of anxiety in children with ADHD improve outcomes? A large-scale randomised controlled trial
Acronym
Study hypothesis
Cognitive behavioural therapy is superior to standard care for the treatment of anxiety in children with ADHD.
Ethics approval
The Royal Children's Hospital Human Research Ethics Committee, 09/09/2015, ref: 35164
Study design
Single-centre randomised controlled trial of a cognitive behavioural treatment versus usual care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
1. Attention deficit hyperactivity disorder (ADHD)
2. Anxiety
Intervention
Children in the intervention arm will receive 10 sessions of cognitive behavioural therapy delivered by study trained psychologists, while the control group will continue to access usual care for management of their ADHD.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Parent report of whether the child meets criteria for an anxiety disorder (separation anxiety disorder, social phobia, or generalised anxiety disorder) 5 months post-randomisation measured by the Anxiety Disorders Interview Schedule for Children 5.
Secondary outcome measures
Secondary outcome measures as of 05/10/2016:
1. Anxiety: Parent and child report of child anxiety symptoms as measured by the Spence Child Anxiety Scale and the Child Anxiety Life Interference Scale; teacher report of anxiety symptoms as measured by the School Anxiety Scale (all measured at baseline, 5 and 12 months post randomisation). Parent report of whether the child meets criteria for an anxiety disorder (separation anxiety disorder, social phobia, or generalised anxiety disorder) 12 months post-randomisation measured by the Anxiety Disorders Interview Schedule for Children 5
2. ADHD symptoms as measured by the ADHD Rating Scale IV (parent and teacher report measured at baseline, 5 and 12 months post randomisation)
2. Psychosocial quality of life as measured by the CHU-9D (parent and child report measured at baseline, 5 and 12 months post randomisation)
3. Behaviour as measured by the Strengths and Difficulties Questionnaire (parent and teacher report measured at baseline, 5 and 12 months post randomisation)
4. Executive functioning as measured by the NIH cognitive toolbox (blinded, direct assessment at baseline, 5 and 12 months post randomisation)
5. Parent mental health as measured by the K6 (measured at baseline, 5 and 12 months post randomisation)
6. Parenting behaviours as measured by a series a questions from the Longitudinal Study of Australian Children (measured at baseline, 5 and 12 months post randomisation)
Original secondary outcome measures:
1. Anxiety: Parent and child report of child anxiety symptoms as measured by the Spence Child Anxiety Scale and the Child Anxiety Life Interference Scale; teacher report of anxiety symptoms as measured by the School Anxiety Scale (all measured at baseline and 5 months post randomisation).
2. ADHD symptoms as measured by the ADHD Rating Scale IV (parent and teacher report measured at baseline and 5 months post randomisation)
2. Psychosocial quality of life as measured by the PedsQL 4.0 (parent and child report measured at baseline and 5 months post randomisation)
3. Behaviour as measured by the Strengths and Difficulties Questionnaire (parent and teacher report measured at baseline and 5 months post randomisation)
4. Executive functioning as measured by the NIH cognitive toolbox(blinded, direct assessment at 5 months post randomisation)
5. Parent mental health as measured by the K6 (measured at baseline and 5 months post randomisation)
6. Parenting behaviours as measured by a series a questions from the Longitudinal Study of Australian Children (measured at baseline and 5 months post randomisation)
Overall trial start date
29/09/2015
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 8 - 12 years
2. Caregiver report of ADHD symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for ADHD (child also needs to have been previously diagnosed with ADHD by a paediatrician)
3. Caregiver report of anxiety symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Separation Anxiety Disorder, Generalised Anxiety Disorder, or Social Phobia
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
228
Participant exclusion criteria
1. Receiving specialised treatment for anxiety from a psychologist or psychiatrist. Participants who are taking medication for anxiety can participate provided they are still experiencing significant anxiety symptoms and have been on stable medication for a minimum of six weeks.
2. Major illness or disability.
3. Non-English speaking
Added 05/10/2016:
4. A score of 15 or greater on the Social Communication Questionnaire, a measure of autism symptoms
Recruitment start date
06/10/2015
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Australia
Trial participating centre
Murdoch Childrens Research Institute (MCRI)
The Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia
Sponsor information
Organisation
Murdoch Childrens Research Institute (MCRI)
Sponsor details
The Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia
+61 3834 16200
mcri@mcri.edu.au
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Murdoch Childrens Research Institute
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sidney Myer Fund and Myer Foundation
Alternative name(s)
Sidney Myer Fund & The Myer Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Australia
Funder name
The National Health and Medical Research Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results will be published in a peer reviewed journal and also presented at international conferences.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be available upon request from emma.sciberras@deakin.edu.au
Intention to publish date
31/12/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 protocol in https://doi.org/10.1186/s12888-019-2276-3 (added 10/06/2020)