Condition category
Mental and Behavioural Disorders
Date applied
10/04/2015
Date assigned
27/04/2015
Last edited
05/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a group of behavioural symptoms that include inattentiveness, hyperactivity and impulsiveness. ADHD has a big impact on the long term health care, education and criminality of diagnosed individuals. Children with a diagnosis of ADHD are at high risk of bad behaviour, such as early criminal behaviour, being disruptive in school and antisocial behaviour. Evidence suggests that while current treatments work well in the short term, they are not improving these long term negative behaviours. ADHD is managed mainly by health services where behavioural therapies and drug treatments are the main options offered. There are also various complementary and alternative medicine (CAM) treatments available to people affected by ADHD. Homeopathy, a 'treatment' based on the use of highly diluted substances, is a CAM sometimes sought by people to treat mental health symptoms, such as those seen in ADHD. Some parents say that using CAM treatments helps manage their children’s symptoms, but there is little evidence to support these claims. Good quality evidence is needed to see whether the CAM treatments parents are trying might actually help children with ADHD. The aim of this study is to see whether treatment by homeopaths or treatment by nutritional therapists have any effect on the symptoms of ADHD when used alongside the usual treatments given to children.

Who can participate?
Children diagnosed with ADHD.

What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 (intervention group) receive treatment by homeopaths. Those in group 2 (intervention group) receive 'treatment by nutritional therapists alongside their usual treatments. Those in group 3 (control group) receive their usual treatments. Parents and teachers of participating children are asked to complete questionnaires relating to the child’s behaviour 6 months after the start of the study.

What are the possible benefits and risks of participating?
There are no benefits or risks associated with this study.

Where is the study run from?
University of Sheffield (UK)

When is the study starting and how long is it expected to run for?
September 2015 to September 2017

Who is funding the study?
The Homeopathy Research Institute (UK)

Who is the main contact?
Mrs P Fibert (scientific)
p.fibert@sheffield.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Philippa Fibert

ORCID ID

http://orcid.org/0000-0001-5364-6022

Contact details

School of Health and Related Research
Sheffield University
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0) 7543 345046
p.fibert@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A pragmatic cohort randomised controlled trial of the clinical and cost effectiveness of treatment by homeopaths or nutritional therapists in addition to usual care, compared to usual care alone, for children with attention deficit hyperactivity disorder (ADHD)

Acronym

Study hypothesis

Current hypothesis as of 05/08/2015:
The aim of this study is to see whether adjunct treatment by homeopaths or nutritional therapists is clinically- and/or cost-effective and acceptable for children with attention deficit hyperactivity disorder (ADHD). We will also assess whether the cohort multiple randomised controlled trial design is feasible to generate evidence about the acceptability, clinical and cost effectiveness of treatment by homeopaths or nutritional therapists for ADHD.

Previous hypothesis:
The aim of this study is to see whether adjunct treatment by homeopaths or polyunsaturated fatty acids is clinically- and/or cost-effective and acceptable for children with attention deficit hyperactivity disorder (ADHD). We will also assess whether the cohort multiple randomised controlled trial design is feasible to generate evidence about the acceptability, clinical and cost effectiveness of treatment by homeopaths or polyunsaturated fatty acids for ADHD.

On 05/08/2015 the following changes were made to the trial record:
1. The public title was changed; the previous public title was 'The effectiveness and cost effectiveness of treatment by homeopaths or polyunsaturated fatty acids in addition to usual care for children with attention deficit hyperactivity disorder (ADHD)'
2. The scientific title was changed; the previous scientific title was 'A pragmatic cohort randomised controlled trial of the clinical and cost effectiveness of treatment by homeopaths or polyunsaturated fatty acids in addition to usual care, compared to usual care alone, for children with attention deficit hyperactivity disorder (ADHD)'

Ethics approval

School of Health and Related Research at Sheffield University, 31/04/2015, ref: 003424, amendment sanctioned 05/08/2015

Study design

Pragmatic trial using the cohort multiple randomised controlled trial design

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 contact details to request a participant information sheet.

Condition

Attention deficit hyperactivity disorder (ADHD)

Intervention

Current interventions as of 05/08/2015:
1. Individualised treatment provided by homeopaths in addition to usual care
2. Individualised treatment by nutritional therapists in addition to usual care
3. Usual care (control)

Previous interventions:
1. Individualised treatment provided by homeopaths in addition to usual care
2. Polyunsaturated fatty acids (EPA omega-3 and GLA omega-6) in addition to usual care
3. Usual care (control)

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Conners' Global Index (CGI) psychopathology questionnaire at 6 months post-baseline (parent/teacher report).

Secondary outcome measures

1. Wellbeing: assessed using Child Health Utility (CHU-9D) index (6 months; parent questionnaire).
2. School performance: classroom disruptiveness; school attendance and school exclusion (6 months; teacher questionnaire).
3. Criminality: contact with the criminal justice system (6 months; parent questionnaire).
4. Emotional lability: 3 questions from CGI (6 months; parent questionnaire).

Overall trial start date

01/09/2015

Overall trial end date

01/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parent reported clinical diagnosis of ADHD
2. CGI T-score of at least 55
3. Age 5-18
4. Able to speak and read English
5. Informed consent (parent and child)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

134

Participant exclusion criteria

1. Children with terminal conditions such as cancer
2. Families where English is not written or spoken
3. Children currently receiving treatment by a homeopath or taking polyunsaturated fatty acids
4. Children with CGI T-score less than 55
5. Children who are vegetarians (PUFA arm)

Recruitment start date

01/09/2015

Recruitment end date

01/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S1 4DA
United Kingdom

Sponsor information

Organisation

University of Sheffield

Sponsor details

University of Sheffield
Regent Court
30 Regent Street
Sheffield
Sheffield
S1 4DA
United Kingdom
+44 (0) 114 222 5454
d.mcclean@sheffield.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

Research organisation

Funder name

The Homeopathy Research Institute

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol is being presented as a poster at the World Federation of ADHD Conference, Glasgow, May 28-31 2015. Feasibility results will be submitted for publication in a peer reviewed ADHD journal (e.g the journal associated with this conference) in 2018. Results will also form a component of PhD thesis submission, due for completion in 2018.

Intention to publish date

01/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes