Protocol summary

Summary
The purpose of this study is to determine the effect of behavioral education for parents on sleep situation in school-age children with attention deficit hyperactivity disorder who referred to pediatric psychiatric clinic in Rasht. Samples of this study contain 60 children between 6 to 12 years old with ADHD. Inclusion criteria: children who just suffer from ADHD or ADHD and ODD based on DSM IV criteria; taking Ritalin; having sleep problems; absence of other mental disorders; mental disabilities; blindness and deafness and so having IQ above 80 . Data collection instrument is Child Sleep Habits Questionnaire. First Questionnaires are completed by parents and then samples with sleep problems divided into control and test group(30) by Randomized Blocks method; then test group divided in two groups (15) for Behavioral training. Training sessions consisted of 5 sessions in 5 weeks: Three sessions are presence training and two sessions are telephone follow-up. Parents of test group can ask their questions with calling researcher. Immediately and two months after sessions Child Sleep Habits Questionnaire are completed by parents again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013042112990N1
Registration date: 2013-05-14, 1392/02/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-14, 1392/02/24
Registrant information
Name
Minoo Mitra Cherhzad
Name of organization / entity
Guilan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5056
Email address
chehrzad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Research and Technology, Guilan University of Medical Sciences
Expected recruitment start date
2013-05-05, 1392/02/15
Expected recruitment end date
2013-08-06, 1392/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of behavioral education to parents on sleep situation of school-age children.
Public title
Effect of behavioral education to parents on sleep situation of school-age children with attention deficit hyperactivity disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: children who just suffer from ADHD or ADHD and ODD based on DSM IV criteria, taking Ritalin; having sleep problems; absence of other mental disorders; mental disabilities; blindness and deafness and so having IQ above 80.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences and Health Services
Street address
Guilan-Rasht,department of reaserch and technology of Guilan University of Medical Science
City
Rasht
Postal code
33967-41938
Approval date
2013-04-20, 1392/01/31
Ethics committee reference number
2920029703

Health conditions studied

1

Description of health condition studied
Attention Deficit and Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention-Attention deficit:

Primary outcomes

1

Description
Sleep position
Timepoint
Before the training, immediately after training, two months after the completion of the training
Method of measurement
Children sleep habits questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The control group wasn't be educated.
Category
Behavior

2

Description
Behavioral education sessions present for educational group in three presence and two telephone follow-up sessions once a week .
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa educatinal & remedial center
Full name of responsible person
Minoo Mitra Chehrzad
Street address
Nursing And Midwifery Faculty of Shahid Beheshti of Rasht
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technolog of Guilan University Medical Sciences
Full name of responsible person
Sobhani Abdolrasool
Street address
Rasht - Blv of Imam Khomeini - the end of the flying bridge - top of Iran's Radiator Building of Deputy of Research of University
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technolog of Guilan University Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mahboobeh Mehri
Position
Bachelor degree in nursing - Nurse
Other areas of specialty/work
Street address
Shafa educational & remedial Center
City
Rasht
Postal code
Phone
+98 13 1550 9761
Fax
Email
mah.mehri@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Minoo Mitra Chehrzad
Position
Master of Science
Other areas of specialty/work
Street address
Shahid Behesht Nursing And Midwifery Faculty of Rasht
City
Rasht
Postal code
Phone
+98 13 1322 5558
Fax
Email
chehrzad@gums.ac.ir; mchehrzad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mahboobeh Mehri
Position
Bachelor degree in nursing - Nurse
Other areas of specialty/work
Street address
Shafa educational & remidial center
City
Rasht
Postal code
Phone
+98 13 1550 9761
Fax
Email
mah.mehri@ymail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...