Clinical Trial: The Effect of Individualised Homoeopathic Treatment of Autism Spectrum Disorder in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Individualised Homoeopathic Treatment of Autism Spectrum Disorder in Children

Brief 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 Summary:

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.
Sponsor: University of Johannesburg

Current Primary Outcome: Childhood Autism Rating Scale [ Time Frame: Every 4 weeks for 12 weeks ]

The Childhood Autism Rating Scale will be conducted at weeks 0, 4, 8 and 12.


Original Primary Outcome:

  • Childhood Autism Rating Scale [ Time Frame: Every 4 weeks for 12 weeks ]
    The Childhood Autism Rating Scale will be conducted at weeks 0, 4, 8 and 12.
  • Autism Treatment Evaluation Checklist [ Time Frame: Every 4 weeks for 12 weeks ]
    The Autism Treatment Evaluation Checklist will be conducted at weeks 0, 4, 8 and 12.
  • Case notes [ Time Frame: Every 4 weeks for 12 weeks ]
    Qualitative data collection will be collect by means of case notes which will be taken at weeks 0, 4, 8 and 12.


Current Secondary Outcome:

  • Autism Treatment Evaluation Checklist [ Time Frame: Every 4 weeks for 12 weeks ]
    The Autism Treatment Evaluation Checklist will be conducted at weeks 0, 4, 8 and 12.
  • Case notes [ Time Frame: Every 4 weeks for 12 weeks ]
    Qualitative data collection will be collect by means of case notes which will be taken at weeks 0, 4, 8 and 12.


Original Secondary Outcome:

Information By: University of Johannesburg

Dates:
Date Received: February 9, 2015
Date Started: February 2015
Date Completion:
Last Updated: May 18, 2016
Last Verified: May 2016