Protocol summary
-
Study aim
-
The evaluation of efficacy of adding acupuncture to Methylphenidate in treatment of attention deficit hyperactivity disorder in children and adolescents
-
Design
-
A randomized, double blinded, sham controlled clinical trial with a parallel group design of 90 patients
-
Settings and conduct
-
This study was conducted on patients with confirmed ADHD referred to Ibn-e-Sina Psychiatric Hospital, Mashhad, Iran between January 2017 and June 2017. Patients were randomly allocated into acupuncture (experimental group) or sham acupuncture (control group). All patients received a standard treatment of 0.3-1 mg/kg of Methylphenidate (Ritalin) in 2 or 3 divided doses. Before the intervention patients were evaluated using home version of ADHD-rating scale (RS) and Continuous Performance Test. Then within 4 weeks the intervention group received acupuncture treatment 3 times a week. Sham acupuncture was used for the control group within the same duration as acupuncture group. The treatment outcomes were measured using home version of ADHD-rating scale (RS) and Continuous Performance Test after 3 weeks. Patients, their parents, child and adolescent psychiatrist and the psychologist who performed before-after tests were not aware of grouping.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: 6 to 18 year old patients with the diagnosis of ADHD by DSM-5 criteria who are on the standard treatment with Methylphenidate or Methylphenidate and Clonidine without any dose change from 2 weeks before the study and during the study
Exclusion criteria: patients with mental retardation, epilepsy, pervasive developmental disorders, schizophrenia, manic episode, mood and anxiety disorders and drug or organic disorder induced hyperactivity
-
Intervention groups
-
Acupuncture (experimental group) and sham acupuncture (control group)
-
Main outcome variables
-
Score of ADHD-rating scale; score of CPT
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2015091121852N1
Registration date:
2016-11-27, 1395/09/07
Registration timing:
prospective
Last update:
2018-03-11, 1396/12/20
Update count:
1
-
Registration date
-
2016-11-27, 1395/09/07
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Mashhad University of Medical Sciences
-
Expected recruitment start date
-
2016-08-22, 1395/06/01
-
Expected recruitment end date
-
2017-03-20, 1395/12/30
-
Actual recruitment start date
-
2016-12-21, 1395/10/01
-
Actual recruitment end date
-
2017-06-20, 1396/03/30
-
Trial completion date
-
empty
-
Scientific title
-
A Study of effect of adding acupuncture to Methylphenidate in treatment of attention deficit hyperactivity disorder(ADHD) in children and adolescents
-
Public title
-
Acupuncture in treatment of attention deficit hyperactivity disorder in children and adolescents
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Written and oral informed consent by parents of participants
Age between 6 to 18 years
The diagnosis of ADHD according to DSM-5 criteria by a child and adolescent psychiatrist
Being on the standard treatment with Methylphenidate or Methylphenidate and Clonidine without any dose changes from 2 weeks before and during the study period
Exclusion criteria:
Patients with mental retardation, epilepsy, pervasive developmental disorders, schizophrenia, manic episode, mood and anxiety disorders and drug or organic disorder induced hyperactivity
Any dose change in the standard drug therapy during the study period
-
Age
-
From 6 years old to 18 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
-
Sample size
-
Target sample size:
90
Actual sample size reached:
90
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Simple randomization by using a random number table
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Randomization was done by a researcher who was not aware of the study protocol and outcomes. Patients and their parents, as well as child and adolescent psychiatrist were not aware of grouping, Moreover, the psychologist, who was the researcher-in-charge of before-after tests, was not aware of interventions. Also, the outcomes of the study were recorded by the psychiatrist who made no other contribution to the study.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2015-06-24, 1394/04/03
-
Ethics committee reference number
-
IR.MUMS.fm.REC.1394.61
Health conditions studied
1
-
Description of health condition studied
-
Attention Deficit Hyperactivity disorder
-
ICD-10 code
-
F90.0
-
ICD-10 code description
-
Disturbance of activity and attention
Primary outcomes
1
-
Description
-
ADHD Rating Scale score
-
Timepoint
-
Before the intervention and 3 weeks after the intervention
-
Method of measurement
-
ADHD Rating Scale-IV questionnaire
2
-
Description
-
Continuous Performance Test score
-
Timepoint
-
Before the intervention and 3 weeks after the intervention
-
Method of measurement
-
Continuous Performance Test
Intervention groups
1
-
Description
-
Patient group will receive acupuncture for 12 sessions(three 40 minute sessions weekly).
-
Category
-
Treatment - Other
2
-
Description
-
Control group will receive sham acupuncture for12 sessions(three 40 minute sessions weekly).In this group special needles are used that do not enter the skin and acupoints are different from the patinent group.
-
Category
-
Treatment - Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Research Affairs of Mashhad University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available