The effectiveness and cost effectiveness of treatment by homeopaths or nutritional therapists in addition to usual care for children with attention deficit hyperactivity disorder (ADHD)
| ISRCTN | ISRCTN17723526 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17723526 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/04/2015
- Registration date
- 27/04/2015
- Last edited
- 26/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Scientific
School of Health and Related Research
Sheffield University
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
 ORCID ID |
0000-0001-5364-6022 |
|---|---|
| Phone | +44 (0)7543 345046 |
| p.fibert@sheffield.ac.uk |
Study information
| Study design | Pragmatic trial using the cohort multiple randomised controlled trial design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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) |
| 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(s) | School of Health and Related Research at Sheffield University, 31/04/2015, ref: 003424, amendment sanctioned 05/08/2015 |
| 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 |
| Primary outcome measure | 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 study start date | 01/09/2015 |
| Overall study end date | 01/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 134 |
| Total final enrolment | 144 |
| 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 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
- England
- United Kingdom
Study participating centre
S1 4DA
United Kingdom
Sponsor information
University/education
Regent Court
30 Regent Street
Sheffield
S1 4DA
England
United Kingdom
| Phone | +44 (0)114 222 5454 |
|---|---|
| d.mcclean@sheffield.ac.uk | |
| Website | http://www.sheffield.ac.uk/ |
"ROR" |
https://ror.org/05krs5044 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/03/2018 | Yes | No | |
| Results article | 01/07/2019 | 26/05/2021 | Yes | No |
Editorial Notes
26/05/2021: Publication reference and total final enrolment added.
08/03/2018: Publication reference added.
