Does the treatment of anxiety in children with ADHD improve outcomes?

ISRCTN ISRCTN59518816
DOI https://doi.org/10.1186/ISRCTN59518816
Secondary identifying numbers N/A
Submission date
10/09/2015
Registration date
29/09/2015
Last edited
10/06/2020
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
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Emma Sciberras
Scientific

Centre for Community Child Health
The Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia

Phone +61 39251 7222
Email emma.sciberras@deakin.edu.au

Study information

Study designSingle-centre randomised controlled trial of a cognitive behavioural treatment versus usual care
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDoes the treatment of anxiety in children with ADHD improve outcomes? A large-scale randomised controlled trial
Study objectivesCognitive behavioural therapy is superior to standard care for the treatment of anxiety in children with ADHD.
Ethics approval(s)The Royal Children's Hospital Human Research Ethics Committee, 09/09/2015, ref: 35164
Health condition(s) or problem(s) studied1. Attention deficit hyperactivity disorder (ADHD)
2. Anxiety
InterventionChildren 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 typeBehavioural
Primary outcome measureParent 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 measuresSecondary 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 study start date29/09/2015
Completion date31/12/2019

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit8 Years
Upper age limit12 Years
SexBoth
Target number of participants228
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment06/10/2015
Date of final enrolment31/12/2018

Locations

Countries of recruitment

  • Australia

Study participating centre

Murdoch Childrens Research Institute (MCRI)
The Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia

Sponsor information

Murdoch Childrens Research Institute (MCRI)
Research organisation

The Royal Children's Hospital
Flemington Rd
Parkville
3052
Australia

Phone +61 3834 16200
Email mcri@mcri.edu.au
Website http://www.mcri.edu.au
ROR logo "ROR" https://ror.org/048fyec77

Funders

Funder type

Research organisation

Murdoch Childrens Research Institute

No information available

Sidney Myer Fund and Myer Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Sidney Myer Fund & The Myer Foundation, Sidney Myer Fund and the Myer Foundation, Myer Foundation and Sidney Myer Fund, Myer Foundation & Sidney Myer Fund's
Location
Australia
The National Health and Medical Research Council

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe results will be published in a peer reviewed journal and also presented at international conferences.
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from emma.sciberras@deakin.edu.au

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 13/11/2019 10/06/2020 Yes No

Editorial Notes

10/06/2020: Publication reference added.
15/01/2019: The intention to publish date has been updated from 31/12/2019 to 31/12/2020.
21/11/2017: The overall trial start date has been updated from 24/09/2015 to 29/09/2015. The recruitment start date has been updated from 24/09/2015 to 06/10/2015.
07/10/2016: The IPD sharing plan has been added.
05/10/2016: The National Health and Medical Research Council (Australia) has been added to the funders list. The additional funding has allowed for the following changes to the outcome measures:
1. A face to face assessment of cognitive functioning at baseline, and
2. A 12 month follow up
In addition, an additional exclusion criterion has been added