The Effect of Individualised Homoeopathic Treatment of Autism Spectrum Disorder in Children
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine the effect of individualised homoeopathic treatment of
      children with Autism Spectrum Disorder (ASD).This study is of descriptive case study design,
      with a structured interview and quantitative measurement components taking place over 12
      weeks, with a consultation every 4 weeks. Children aged 3-6 years of age with ASD are invited
      to participate and their parent/guardian is required to be present during each consultation.
      Each consultation will consist of a homoeopathic case taking, conduction of the Childhood
      Autism Rating Scale (CARS) and Autism Treatment Evaluation Checklist (ATEC) measures and a
      brief physical exam. After each consultation, the participant will receive an individualised
      homoeopathic remedy, according to their individual symptoms and characteristics, to take for
      the subsequent 4 weeks. This remedy will be determined using the Mercurius® repertory
      software.
    

Detailed description: 
      The aim of this study is to determine the effect of individualised homoeopathic treatment of
      children with Autism Spectrum Disorder (ASD). A minimum of 10 participants between the ages
      of 3 to 6 years, both male and female, will be recruited. This study is of a descriptive case
      study design, with a structured interview and quantitative measurement components. The data
      collection will take place over 12 weeks at both the University of Johannesburg's Health
      Training Centre and the schools for Autistic children within Gauteng.

      A parent/guardian must be present for all consultations to aid data collection. Week 0 will
      consist of an explanation of the study, the Participant Information and Assent Form and the
      Parent/Guardian Information Form . The Consent Form will be signed by the parent or guardian
      if they wish their child to participate in the study. The child will also be informed on the
      details of the study and have to consent to their participation.

      The participant will be screened using screening checklist, which includes the completion of
      the CARS by the researcher and guardian, to determine their eligibility to take part in the
      research study. If they are eligible to take part in the study, the researcher will conduct a
      case taking, the ATEC and a relevant physical examination (including vital signs). This
      information will serve as a baseline for each participant in the study along with the
      previous information attained from the CARS used in the participant's screening.

      The first interview will consist of a structured interview of approximately 90 minutes
      duration with the parent/guardian, where after the following structured interviews will take
      60 minutes, wherein the participant will be free to move around and interact with their
      environment as naturally as possible.

      The researcher will then establish the participant's individualised homoeopathic remedy
      according to the principles of classical homoeopathy by using the Complete Repertory 2014
      provided in Mercurius® repertory software.The selected remedy will be provided to the
      participant within 24 hours with instruction on how to take it.

      The participant will be consulted with their parent/guardian 3 more times, at weeks 4, 8 and
      12, where on each occasion they will have their case taken, the CARS and the ATEC conducted
      as well as a relevant physical examination. At the interviews on week 4 and 8, each case will
      be re-evaluated and the appropriate individualised homoeopathic remedy dispensed. Each
      participant will receive their individualised homoeopathic remedy in aqua distilla drops to
      be put into the participant's mouth, which will be prescribed with the most suitable
      repetition and potency for the participant, according to laws of homoeopathy that govern
      individualised homoeopathic prescribing. The case taking will assist in determining the
      potency and frequency of the remedy given. No remedy will be dispensed at week 12.

      Data will be analysed by Statkon using non-parametric tests including the Friedman and the
      Wilcoxin post-hoc analyses. A positive outcome of this study will contribute to the
      accessibility of a complementary treatment for ASD as well as denote the requirement for
      further research studies on the subject. The outcome of this study may add to the body of
      knowledge of individualised homoeopathic treatment on ASD.
    

Intervention name(s): Individualised homoeopathic remedy in aqua distilla
Intervention type(s): Other
Intervention description(s): Each participant is to receive an individualised homoeopathic remedy according to their symptoms and characteristic manifestations of their disorder.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Children; Homoeopathy