Condition category
Mental and Behavioural Disorders
Date applied
08/09/2010
Date assigned
23/12/2010
Last edited
12/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Attention deficit-hyperactivity disorder (ADHD) is the most common childhood onset neurobehavioral disorder and is estimated to affect around 4-12% of 6-12 year olds. ADHD is characterised by developmentally inappropriate hyperactivity, impulsivity, and inattention continuing throughout life. Although there is existing research relating to poorer health and social outcomes for ADHD children, little of this work uses generic quality of life measures, or those which can be converted into utility measures, such as Quality Adjusted Life Years (QALYs). This study aimed to address gaps in the existing knowledge base of quality of life of families who have a child with ADHD, through an observational study of children with ADHD and their families. The results will paint a detailed picture of what life is like for families who live with a child with ADHD, and how this impacts upon the health and well-being of all family members.

Who can participate?
Children aged 6 to 18 with a current diagnosis of ADHD, and their parents/guardians and siblings. Families where there were no children with ADHD were also recruited as the control group.

What does the study involve?
Questionnaires were given to children with ADHD and their families at one time point. There were six questionnaire booklets to be completed by a family, though the number of booklets varied according to the number of family members. There was a booklet for all children to complete, booklets for the main carer to complete about all children, and booklets for both carers to complete. A booklet was also sent to the child with ADHD's teacher and the research nurse completed a booklet from the child with ADHD's clinical notes. In addition, the main carer in 100 of the families recruited also completed a Daily Mood Diary for one week, where a set of 15 questions were asked 10 times a day. Families where there were no children with ADHD were also recruited and completed the questionnaire booklets and the daily diaries; this was the control group.

What are the possible benefits of participating?
There were no direct benefits and there were no risks to the families in taking part in the study as it was an observational study and there was no change to the child with ADHD’s treatment due to the study. However, the results of the study may help research into ADHD and the impact this condition has upon families.

Where is the study run from?
Families were recruited from 15 NHS trusts over the UK, and the trial was run from the University of Sheffield (UK).

When is the study starting and how long is it expected to run for?
Families were recruited between December 2010 and August 2012, and the control group continued to be recruited up to March 2013.

Who is funding the study?
The study was funded by Shire Pharmaceuticals (UK).

Who is the main contact?
Prof John Brazier

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Brazier

ORCID ID

http://orcid.org/0000-0001-8645-4780

Contact details

University of Sheffield
SCHARR
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Type

Public

Additional contact

Ms Katie Briggs

ORCID ID

Contact details

University of Sheffield
SCHARR
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 114 222 6128
c.e.biggs@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8590; Version 1

Study information

Scientific title

Assessing the impact of children with attention-deficit hyperactivity disorder (ADHD) on the health and well-being of their families: an observational cross-sectional study

Acronym

Study hypothesis

This study will fill in a number of important knowledge gaps regarding attention-deficit hyperactivity disorder (ADHD) and its impact on the child and family members. Questionnaires will be given to children with ADHD (6 - 18 years old) and their families. The data from these questionnaires will be expressed in generic health-related quality of life (HRQoL) or utility measures for families where at least one child has ADHD. The use of HRQoL measures in economic evaluation to aid decision making in the NHS is widespread.

In one geographical area the main carer in the family will complete an electronic mood diary for one week and this will be compared with a control group matched by postcode and family size.

Ethics approval

Sheffield Medical Research Ethics Committee (MREC), 26/05/2010, ref: 10/H1308/14

Study design

Multicentre observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Other

Trial type

Quality of life

Patient information sheet

See additional files

Condition

Attention deficit hyperactivity disorder

Intervention

Amended as of 12/01/2010:
This is a cross-sectional study administering questionnaires. There are six booklets to be completed by a family, though the number of booklets will vary according to the number of family members. There is a booklet for all children to complete, booklets for the main carer to complete about all children and booklets for both carers to complete. A booklet will also be sent to the child with ADHD's teacher and the research nurse will complete a booklet from the child with ADHD's medical notes.

The main carer in 100 of the families recruited will also complete a Daily Mood Diary for one week, where a set of 15 questions will be asked 10 times a day.

Follow-up length: 0 months
Study entry: registration only

Initial information at time of registration:
This is a cross-sectional study administering questionnaires. There are six booklets to be completed by a family, though the number of booklets will vary according to the number of family members. There is a booklet for all children to complete, booklets for the main carer to complete about all children and booklets for both carers to complete. A booklet will also be sent to the child with ADHD's teacher and the research nurse will complete a booklet from the child with ADHD's medical notes.

The main carer will also complete a Daily Mood Diary for one week, where a set of 15 questions will be asked 10 times a day.

Follow-up length: 0 months
Study entry: registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Health related quality of life (parents) is measured using the EQ5D at one time point.

Secondary outcome measures

Secondary outcome measures as of 12/05/2017:
Children:
1. Health related quality of life is measured using the Child Health Utility (CHU-9) questionnaire at at one time point
2. Health related quality of life is measured using the EQ-5D-Y (Youth version) at at one time point
3. Life satisfaction is measured using questions taken from the survey "Understanding Society"at one time point
4. Sibling bullying is measured using questions taken from the survey "Understanding Society" at one time point

Parents:
1. Life satisfaction is measured using questions taken from the survey "Understanding Society" at one time point
2. Marital satisfaction is measured using questions taken from the survey "Understanding Society" at one time point
3. Positive mental health is measured using questions taken from the survey "Understanding Society" at one time point
4. Positive moods is measured using questions taken from the survey "Understanding Society" at one time point
5. Productivity is measured using questions taken from the survey "Understanding Society" at one time point
6. Sleep disruptions are measured using questions taken from the survey "Understanding Society" at one time point
7. ADHD symptoms of the child with ADHD are measured using ADHD rating scale (ADHD RS-IV) at one time point
8. The impact of behavioural symptoms on daily functioning of the child with ADHD are measured using the Strength and Difficulties Question (SDQ) at one time point
9. The impact of behavioural symptoms on daily functioning of the child with ADHD are measured using the WEISS Functional Impairment Scale at one time point
10. ADHD symptoms of the parent are measured using the Adult self-report scale (ASRS v1.1) at one time point

Original secondary outcome measures:
1. For children:
1.1. Child Health Utility (CHU-9)
1.2. EQ-5D-Y (Youth version)
1.3. Life satisfaction
1.4. Sibling bullying

2. For parents:
2.1. Life satisfaction
2.2. Marital satisfaction
2.3. Positive mental health
2.4. Positive moods
2.5. Productivity
2.6. Sleep disruptions

Overall trial start date

01/04/2009

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. A child with a current diagnosis of ADHD aged 6 to 18 years, either sex
2. Siblings must be between 6 and 18 and living at home with the ADHD child
3. Parents/guardians must be living at home with the ADHD child

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1000 families, approx 4000 individuals

Participant exclusion criteria

1. A child with a comorbid diagnosis of conduct disorder
2. The ADHD child is attending the clinic for the first time following their diagnosis

Recruitment start date

01/12/2010

Recruitment end date

30/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medway Maritime Hospital
Residence 13
Gillingham
ME7 5NY
United Kingdom

Trial participating centre

Ashurst Child and Family Centre
Lyndhurst Road Ashurst
Southampton
SO40 7AR
United Kingdom

Trial participating centre

Centre for Child Health
19 Dudhope Terrace
Dundee
DD3 6HH
United Kingdom

Trial participating centre

CAMHS
Benton House Sandyford Road
Newcastle upon Tyne
NE2 1QE
United Kingdom

Trial participating centre

Queen's Medical Centre
Child and Adolescent Psychiatry Department E Floor South Block
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

CAMHS
Derbyshire Mental Health Services NHS Trust The Townhouse 1235 Green Lane
Derby
DE1 1RZ
United Kingdom

Trial participating centre

John Coupland Hospital
Lincolnshire Partnership NHS Foundation Trust CAMHS Morton Centre Ropery Road
Gainsborough
DN21 2TJ
United Kingdom

Trial participating centre

Wolfson Research Institute
Tees Esk & Wear Valleys NHS Foundation Trust Centre for Integrated Healthcare Research University Boulevard Thornaby
Stockton-on-Tees
TS17 6BH
United Kingdom

Trial participating centre

CAMHS
Rotherham Doncaster and South Humber Mental Health NHS Foundation Trust
Rotherham
S65 1DJ
United Kingdom

Trial participating centre

Great North Children's Hospital
Newcastle Upon Tyne Hospitals NHS Foundation Trust CAHMS Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Ryegate Children's Centre
Sheffield Children's NHS Foundation Trust CAMHS Tapton Crescent Road
Sheffield
S10 5DD
United Kingdom

Trial participating centre

Harlow CAMHS
North Essex Partnership NHS Foundation Trust Wych Elm
Harlow
CM20 1QR
United Kingdom

Trial participating centre

Valentine Centre
Leicestershire Partnership NHS Trust CAMHS
Leicester
LE7 7GX
United Kingdom

Trial participating centre

Sustain (CAMHS)
Coventry and Warwickshire NHS Trust Gulson Clinic Gulson Road
Coventry
CV1 2SU
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

Samuel Fox House
Sheffield
S1 4DT
United Kingdom

Sponsor type

University/education

Website

http://www.sheffield.ac.uk/

Funders

Funder type

Industry

Funder name

Shire (Jersey) (UK)

Alternative name(s)

Shire Pharmaceuticals

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Ireland

Results and Publications

Publication and dissemination plan

Other publications regarding the results in relation to parent outcomes and on Part B of the study (daily diaries) are planned.

IPD Sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available as consent was not sought from participants for this. There may be some scope for the sharing of anonymised data, please contact the study lead John Brazier.

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27037707

Publication citations

Editorial Notes

12/05/2017: Publication reference added. In addition, the following changes have been made to the record: 1. The overall trial dates have been updated from 01/03/2010 - 01/03/2012 to 01/04/2009 - 31/12/2012 2. The recruitment dates have been updated from 01/03/2010 - 01/03/2012 to 01/12/2010 - 30/09/2012 3. Katie Briggs, the study manager has been added as a public study contact 4. The participant information sheets have been uploaded 5. The IPD sharing statement, publication and dissemination plan and trial participating centres have been added 6. The outcome measures have been updated to include the timepoints and methods of measurement