Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000332527
Ethics application status
Approved
Date submitted
31/07/2006
Date registered
4/08/2006
Date last updated
2/12/2008
Type of registration
Retrospectively registered

Titles & IDs
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).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD) 1301 0
Condition category
Condition code
Mental Health 1392 1392 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1023 0
Treatment: Other
Comparator / control treatment
(1) Control group approx 35 participants; ADHD children on existing treatment plan
Control group
Active

Outcomes
Primary outcome [1] 1896 0
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.
Timepoint [1] 1896 0
At 1 & 7 months.
Secondary outcome [1] 3355 0
A decrease in the subscales of CPRS:R-L in inattention, hyperactivity, and impulsivity.
Timepoint [1] 3355 0
At 1 & 7 months.

Eligibility
Key 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.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Via random number generator method
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Placebo group receiving sham treatment
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
93
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1323 0
2109

Funding & Sponsors
Funding source category [1] 1525 0
University
Name [1] 1525 0
Macquarie University Student Research Fund
Country [1] 1525 0
Australia
Funding source category [2] 1526 0
Self funded/Unfunded
Name [2] 1526 0
Country [2] 1526 0
Primary sponsor type
Individual
Name
Dr Henry Pollard (Primary Supervisor, Director of Research- Dept Health & Chiropractic Macquarie University)
Address
Department of Health & Chiropractic
Macquarie University Sydney 2109 NSW
Country
Australia
Secondary sponsor category [1] 1340 0
Individual
Name [1] 1340 0
Fay Karpouzis
Address [1] 1340 0
Department of Health & Chiropractic
Macquarie University Sydney 2109 NSW
Country [1] 1340 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2948 0
MACQUARIE UNIVERSITY
Ethics committee address [1] 2948 0
Ethics committee country [1] 2948 0
Australia
Date submitted for ethics approval [1] 2948 0
Approval date [1] 2948 0
26/08/2005
Ethics approval number [1] 2948 0
HE26AUG2005-M04261

Summary
Brief summary
GENERAL AIM: -To determine whether the addition of a Chiropractic (NET) intervention to a pre-existing treatment can improve the outcomes of children with clinically diagnosed ADHD. SPECIFIC AIMS: -To determine whether chiropractic (NET) treatment in addition to a pre-existing treatment is more effective than that pre-existing treatment alone in children with ADHD. -To determine the responses of the above in the short term (1 month) and long term (7 months). NULL HYPOTHESIS: -That the addition of Chiropractic (NET) intervention has no effect on the clinical outcomes of children with clinically diagnosed ADHD. THE CLINICAL OUTCOMES BEING INVESTIGATED ARE: (1) Decrease in CPRS-R:L & CTRS-R:L (2) Decrease in subscales of CPRS-R:L & CTRS-R:L eg decrease in inattention, impulsivity, hyperactivity. Those who will be blinded in the study are the participants and their parents, the assessor and the data analyst.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36118 0
Address 36118 0
Country 36118 0
Phone 36118 0
Fax 36118 0
Email 36118 0
Contact person for public queries
Name 10212 0
Fay Karpouzis
Address 10212 0
PO BOX 2108, ROSE BAY NTH, NSW 2030
Country 10212 0
Australia
Phone 10212 0
+61 418 444427
Fax 10212 0
+61 2 93882005
Email 10212 0
faykchiro@optusnet.com.au
Contact person for scientific queries
Name 1140 0
Fay Karpouzis
Address 1140 0
PO BOX 2108, ROSE BAY NTH, NSW 2030.
Country 1140 0
Australia
Phone 1140 0
+61 418 444427
Fax 1140 0
+61 2 93882005
Email 1140 0
faykchiro@optusnet.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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