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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12606000332527
Date of registration: 04/08/2006
Prospective Registration: No
Primary sponsor: Dr Henry Pollard (Primary Supervisor, Director of Research- Dept Health & Chiropractic Macquarie University)
Public title: An Investigation of Chiropractic NET for Attention Deficit Hyperactivity Disorder in Children.
Scientific title: A Comparative Clinical Investigation to determine whether the addition of Chiropractic Neuro Emotional Technique (NET) to an existing treatment (treatment plan participant is already on as prescribed by their referring specialist eg pharmacologic or psychotherapeutic treatment plan) can improve outcomes (ie; decrease inattention, hyperactivity and impulsivity) as measured by Conners’ Parent Rating Scales-Revised:Long Version (CPRS-R:L) & Conners' Teacher Rating Scales-Revised:Long Version (CTRS-R:L) in children with Attention Deficit Hyperactivity Disorder (ADHD).
Date of first enrolment: 01/07/2006
Target sample size: 93
Recruitment status: Recruiting
URL:  https://anzctr.org.au/ACTRN12606000332527.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Phase 2
Countries of recruitment
Australia
Contacts
Name: Fay Karpouzis   
Address:  PO BOX 2108, ROSE BAY NTH, NSW 2030. Australia
Telephone: +61 418 444427
Email: faykchiro@optusnet.com.au
Affiliation: 
Name: Fay Karpouzis   
Address:  PO BOX 2108, ROSE BAY NTH, NSW 2030 Australia
Telephone: +61 418 444427
Email: faykchiro@optusnet.com.au
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Diagnosis of ADHD made using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (1994 & 2000).Inclusion Criteria will include children with; (a) a diagnosis of ADHD currently undergoing any traditional treatments and/or interventions ie; pharmacological, psychosocial therapy, psychotherapy, special educators, occupational therapy etc or combinations of the above, for a minimum of 2 months, or any children with a diagnosis of ADHD for a min of 2 months who have not undergone any treatment. (b) the following comorbid disorders will not be precluded from participation - Conduct Disorder (CD), Oppositional Defiant Disorder (ODD), Learning Disabilities (LD), and Anxiety Disorders, providing ADHD is the primary diagnosis as per DSM-IV.
Exclusion criteria: Children who have language difficulties, Communication disorders, Autism, Mutism, Asperger’s Syndrome, deafness, mood disorders and any other physical or mental disability that makes participation difficult.

Age minimum: 5 Years
Age maximum: 12 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Mental Health - Other mental health disorders
Attention Deficit Hyperactivity Disorder (ADHD);
Attention Deficit Hyperactivity Disorder (ADHD)
Intervention(s)
2 Experimental GROUPS:- approx 35 participants in each group, will be randomly allocated to (2) Experimental Group 1: ADHD children on existing treatment plan plus NET treatment (3) Experimental group 2: ADHD children on existing treatment plan plus sham NET treatment Experimental groups will be treated 2x/week for 1 month, then 1x/month for 6 months at which time study will conclude. At start time, 1 month & at 7 months CPRS-R:L questionnaires will be issued to parents to complete.
Primary Outcome(s)
Primary outcomes measured are the 3 core features of ADHD (ie; inattention, hyperactivity, and impulsivity) as measured by the Conners’ Parent Rating Scales: Revised-Long Version (CPRS:R-L). Positive outcomes would show a decrease in the CPRS:R-L overall. [At 1 & 7 months.]
Secondary Outcome(s)
A decrease in the subscales of CPRS:R-L in inattention, hyperactivity, and impulsivity.[At 1 & 7 months.]
Secondary ID(s)
Source(s) of Monetary Support
Macquarie University Student Research Fund
Secondary Sponsor(s)
Fay Karpouzis
Ethics review
Status: Approved
Approval date:
Contact:
MACQUARIE UNIVERSITY
Results
Results available:
Date Posted:
Date Completed:
URL:
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