Clinical trial NCT02086864: A Placebo Controlled Study of Homeopathic Treatment of Children and Youth With ADHD
Official title: A Randomized, Double Blind, Placebo Controlled Study of Homeopathic Treatment of Children and Youth With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
ADHD
Homeopathy
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Lotte & John Hecht Memorial Foundation
name: Centre for Addiction and Mental Health
First posted: 2014-03-13
Enrollment: 151
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that presents during childhood, with at least some symptoms causing impairment before the age of seven. It is characterized by developmentally inappropriate levels of inattention and/or hyperactive-impulsive behavior, with significant impairment occurring in at least two settings. It affects approximately 5.2 million children in the United States. Homeopathic treatment has been shown to be a promising intervention for ADHD, however the reasons for that effectiveness is unclear. Specifically, it is unclear whether improvement is due to the homeopathic medicine, the consultative process, or other non-specific effects.

This study has 3 primary objectives: 1. to determine if there are any specific effects of homeopathic medicines in the treatment of ADHD, 2. to determine if there any specific effects the homeopathic consultation alone in the treatment of ADHD, and 3. to determine if there is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD.

This is a three arm study. Participants will be randomized to one of three arms:

Arm 1 (Verum group): a treatment arm where the participant will receive homeopathic consultation plus a homeopathic remedy Arm 2 (Placebo group): a treatment arm where the participant will receive homeopathic consultation plus a placebo remedy Arm 3 (Usual care group): participants will continue with usual care and will not receive homeopathic treatment as part of the study.

Participants enrolled in this study, regardless of which study Arm they are in, may continue with all conventional medications or any other aspect of their current standard of care they are taking as recommended by their usual physician (so long as they are on a stable dose of the conventional ADHD medication for at least 6 weeks prior to beginning the trial). They may also continue to attend regularly scheduled visits with their own health care practitioner(s).

Participants may also start, stop or change the dose of any therapy (including conventional medications) during the study and are asked to report the change to the study team. Thus, the placebo group participants are not different than other participants, except that they will have a homeopathic consultation and a placebo remedy. The use of placebo is specific to homeopathic treatment, to allow for double-blinding, which is recognized to reduce study bias.

Prior to enrolling in the study, those considering participation will undergo a full assessment by a psychiatrist with a specialty in child and youth mental health. This assessment confirms the diagnosis and screens for inclusion/exclusion study criteria. At the same time, the psychiatrist recommends evidence-based therapies to clients including conventional medication. The psychiatrist does not directly treat the client. If medication is recommended and the clients wish to pursue it with their regular physician, they would still be able to enroll in the study if they wanted to, after six weeks of reaching a stable dose.

This study will help our understanding of the treatment process and whether different elements of the intervention have greater or lesser effects.

This study is a follow-up to an open label pilot study of the homeopathic treatment of ADHD using the same study team. Sample size was calculated based on the results of that study.


Eligibility criteria: Inclusion Criteria:

* have a diagnosis of attention deficit hyperactivity disorder (and any of the subtypes of the diagnosis) confirmed by study psychiatrist
* have a minimum baseline score on the Connors 3 scale that is 1.5 standard deviations above the population norm based in the age and sex of the participant as was reported to be most commonly used in ADHD treatment trials
* are between 6 and 16 years of age
* are able to ingest medications in liquid or in lactose/sucrose granule form;
* if currently taking stimulant therapy for ADHD, are on a stable dose for a minimum of 6 weeks prior to beginning the study
* have an estimated I.Q. within the normal range
* have parents/guardians who are able to read and write in English

Exclusion Criteria:

* a diagnosis with an additional mental health disorder including, but not limited to, the following: Conduct Disorder, Autism Spectrum Disorder, Bipolar Disorder, and Major Depressive Disorder
* any significant suicidality
* an addiction to any substance
* taking any other prescription medication aside from a stable dose of ADHD medication
* a history of head injury (with sequelae), seizures, or organ system damage
* pregnant or lactating

Primary outcomes:
measure: Change from baseline in Conners 3 Global Index - Parent
timeFrame: Baseline and weeks 8, 20, 28
Secondary outcomes:
measure: Change from baseline in Conners ADHD Index Probability score
timeFrame: Baseline and weeks 8, 20, 28
measure: Change from baseline in Conners Content Scale for Inattention and Hyperactivity/Impulsivity
timeFrame: Baseline and weeks 8, 20, 28
measure: Change from baseline in Conners DSM-IV-TR Symptom Scale for the ADHD Inattentive and ADHD Hyperactive-Impulsive subtypes
timeFrame: Baseline and weeks 8, 20, 28
measure: Clinical Global Impression-Improvement scale
timeFrame: Week 28
measure: Change from baseline in the Pediatric Quality of Life Inventory
timeFrame: Baseline and weeks 8, 20, 28
measure: Change from baseline in Consultation and Relational Empathy measure
timeFrame: Baseline and weeks 8, 20, 28
measure: Change from baseline in RTI Provider Support Measure
timeFrame: Baseline and weeks 8, 20, 28
measure: Change from baseline in the Resiliency Scales for Children & Adolescents - Mastery sub-scale
timeFrame: Baseline and weeks 8, 20, 28
measure: Change from baseline in Coping Efficacy Scale
timeFrame: Baseline and weeks 8, 20, 28
measure: Change from baseline in Control Beliefs Inventory - Mastery sub-scale
timeFrame: Baseline and weeks 8, 20, 28
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Riverdale Homeopathic Clinic
state: Ontario
Study officials:
affiliation: University of Toronto
name: Heather Boon, PhD
role: PRINCIPAL_INVESTIGATOR
References: