Condition category
Mental and Behavioural Disorders
Date applied
24/09/2013
Date assigned
02/10/2013
Last edited
08/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A large number of children with attention deficit hyperactivity disorder (ADHD) also have an anxiety disorder (25-50%). Children who have both ADHD and anxiety have poorer quality of life, daily functioning, and social functioning, and their parents have increased mental health difficulties and are more likely to miss work. Even when anxiety is identified in these children, symptoms may be managed using medication rather than behavioural interventions, but behavioural interventions may be more acceptable to parents. This study aims to assess the feasibility and acceptability of a cognitive behavioural treatment (CBT) program aiming to treat anxiety problems in children with ADHD and to explore the impact on child and family outcomes.

Who can participate?
Children aged 8-12 years with ADHD and anxiety who have previously participated in ADHD research at the Murdoch Childrens Research Institute and indicated an interest in future research.

What does the study involve?
Participants will be randomly allocated to a either a treatment group or a usual care group Participants in the treatment group will attend 10 sessions with a clinician where they will learn strategies to manage their anxiety. Participants in the usual care group will be able to access usual care for their ADHD from their paediatrician.

What are the possible benefits and risks of participating?
Participants in the treatment group may have improved anxiety which may lead to improvements in the child’s behaviour and wellbeing. This may also improve parent wellbeing. Participants in the usual care group will not receive any direct benefit from participation. We do not anticipate any risks, side-effects, or discomforts as a result of participation.

Where is the study run from?
The study has been set up by the Murdoch Childrens Research Institute (MCRI) at the Royal Children’s Hospital (Australia).

When is the study starting and how long is it expected to run for?
The study is expected to start in October 2013. Follow-up information will be collected from participants 5 months after they are enrolled in the study.

Who is funding the study?
Murdoch Childrens Research Institute (MCRI), Australia.

Who is the main contact?
Melissa Mulraney
melissa.mulraney@mcri.edu.au

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Sciberras

ORCID ID

Contact details

Royal Children's Hospital
Centre for Community Child Health
Flemington Road
Parkville
3052
Australia
+61 3 9345 6662
emma.sciberras@mcri.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Does the identification and treatment of comorbid anxiety disorders in children with attention deficit hyperactivity disorder (ADHD) improve outcomes: pilot for a large-scale randomised controlled trial

Acronym

Study hypothesis

We hypothesise that the intervention will be a feasible and acceptable treatment for anxiety in children with ADHD.

On 08/05/2014 the anticipated end date was changed from 30/04/2014 to 30/07/2014.

Ethics approval

Royal Children’s Hospital Human Research Ethics Committee, 30/10/2013

Study design

Single-centre randomised controlled 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

Attention-deficit hyperactivity disorder (ADHD) and anxiety

Intervention

Cool Kids Program (intervention group):
The intervention will be administered by a clinical child psychologist and a study-employed research assistant. The research assistant will receive training in the intervention administration by the PI, a clinical child psychologist and will also attend a one day Cool Kids Program training workshop, run by the developers of the program at Macquarie University in Sydney.
Parents and children will be seen for eight weekly hour-long sessions followed by two biweekly hour-long sessions (total of 10 sessions). The Cool Kids Program aims to help families and children to learn about anxiety and worries and to develop the skills to be able to manage child anxiety. Each session will include time with the child alone, time with parents alone and time with the whole family.

Usual care (control group):
Families in the usual care group will be able to access usual care for ADHD from their child’s paediatrician and/or other health services.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Acceptability and feasibility will be measured at 4 months post-randomisation through:
1. Participant uptake of the intervention
2. Intervention session attendance
3. Rates of participant drop-out
4. Parent and child completed evaluation of the treatment program

Secondary outcome measures

Secondary child outcomes will be measured at 4 months post randomisation and include:
1. Anxiety diagnoses (Anxiety Disorders Interview Schedule for DSM-IV – parent report)
2. Anxiety symptoms (Spence Child Anxiety Scale – parent and child report; School Anxiety Scale – teacher report)
3. ADHD symptoms (ADHD Rating Scale IV – parent and teacher report)
4. Overall behaviour (Strengths and Difficulties Questionnaire – parent and teacher report)
5. Quality of life (Pediatric Quality of Life Questionnaire 4.0 – parent report)
6. Sleep problem – none, mild, moderate, severe (parent report)
7. School attendance over the past 3 months (days late, days missed – parent report)

Secondary primary caregiver outcomes will be measured at 4 months post randomisation and include:
1. Mental health symptoms (Depression Anxiety Stress Scale)
2. Work attendance over the past 3 months (days late, days missed)

Overall trial start date

14/10/2013

Overall trial end date

30/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Families of children aged 8-12 years who have previously participated in ADHD research at Murdoch Childrens Research Institute (MCRI) and have indicated an interest in hearing about future research.
2. Participants must live within a 40km radius of the Royal Children’s Hospital and have caregiver report of:
2.1. ADHD symptoms meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD (child also needs to have been previously diagnosed with ADHD by a paediatrician)
2.2. Anxiety symptoms meeting DSM-IV criteria for at least one of the following anxiety disorders: generalised anxiety disorder, separation anxiety disorder, or social phobia
3. 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Receiving specialised treatment for their anxiety from a psychologist or psychiatrist
2. Major illness or disability
3. Non-English speaking

Recruitment start date

14/10/2013

Recruitment end date

30/07/2014

Locations

Countries of recruitment

Australia

Trial participating centre

Royal Children's Hospital
Parkville
3052
Australia

Sponsor information

Organisation

Murdoch Childrens Research Institute (Australia)

Sponsor details

Royal Children's Hospital
Flemington Road
Parkville
3052
Australia
+61 3 8341 6200
mcri@mcri.edu.au

Sponsor type

Research organisation

Website

http://www.mcri.edu.au/

Funders

Funder type

Research organisation

Funder name

Murdoch Childrens Research Institute (MCRI) (Australia) - MCRI Population Health Theme

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

Publication citations

Additional files

Editorial Notes