Protocol summary

Summary
Objectives: A Study to Determine the Impact of a Sleep Hygiene Intervention on Sleep Habits in Children with Attention Deficit Hyperactivity Disorder (ADHD) and Comorbid Sleep Disorders Study Design: Clinical trial, Interventional, Not blinded, Randomized. The study Population: Children aged 7 to 13 years who refer to Ali-Asghar Children's Hospital, and Tehran Institute of Psychiatry. Inclusion criteria: Age of 7 to 13 years; having ADHD diagnosis based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-VI-TR) criteria; having at least one sleep disorder formally confirmed by a child psychiatrist. Exclusion criteria: Suffering from an acute or chronic medical illness or mental disorder; and using medications for sleep disorders. Target Sample Size: 62 Participants Study Intervention: Sleep hygiene education In this study we will use Children's Sleep Habits Questionnaire (CSHQ) for data collection. At the baseline Questionnaires will be completed by children's mothers in the both experimental and control groups. Mothers of the children in experimental group will receive a sleep hygiene educational intervention which deliver through a training session and a booklet will follow by two follow up telephone calls were made at the third and fifth weeks after intervention and educational cell phone text messages based on the study purposes. Participants in the control group will receive usual clinical care. The post-test will perform two months after intervention, and then data will be analyzed; 1) To determine the effect of training in experimental group 2) To compare the experimental group with the control group Primary outcome: Improved sleep habits in experimental group 2 months after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016100830212N1
Registration date: 2016-11-29, 1395/09/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-29, 1395/09/09
Registrant information
Name
Hedieh Shahhatami
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 7711 9728
Email address
h.shahhatami@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Faculty of Medical Sciences, Tarbiat Modares University
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-11-20, 1394/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Study to Determine the Impact of a Sleep Hygiene Intervention on Sleep Habits in Children with Attention Deficit Hyperactivity Disorder (ADHD) and Comorbid Sleep Disorders
Public title
The Impact of Good Sleep Hygiene on Sleep Habits in Children with Attention Deficit Hyperactivity Disorder (ADHD)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age of 7 to 13 years; having ADHD diagnosis based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-VI-TR) criteria; having at least one sleep disorder formally confirmed by a child psychiatrist Exclusion criteria: Suffering from an acute or chronic medical illness or mental disorder; and using medications for sleep disorders
Age
From 7 years old to 13 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Medical Sciences, Tarbiat Modares University
Street address
No 14115-111, Jalal Al Ahmad Highway, Tehran
City
Tehran
Postal code
Approval date
2015-05-27, 1394/03/06
Ethics committee reference number
IR.TMU.REC.1394.63

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

2

Description of health condition studied
Sleep Disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders

Primary outcomes

1

Description
Sleep habits
Timepoint
Befor and two months after intervention
Method of measurement
Children Sleep Habits Questionair (CSHQ)

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Control group: Usual clinical care
Category
Behavior

2

Description
Intervention group: Sleep hygiene education and usual clinical care
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Asghar Children's Hospital
Full name of responsible person
Hedieh Shahhatami
Street address
Vahid Dastgerdi St.,Shariati Ave,Tehran,Iran
City
Tehran

2

Recruitment center
Name of recruitment center
Tehran Psychiatric Institute
Full name of responsible person
Hedieh Shahhatami
Street address
ShahiedMansuri St., Niayesh St., Sattarkhan Ave., Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
said mousavian
Street address
No 14115-111, Jalal Al Ahmad Highway, Tehran
City
Tehran
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, Faculty of Medical Sciences, Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Mansoureh Movahedin
Position
Ph.D. of Anatomy
Other areas of specialty/work
Street address
No 14115-111, Jalal Al Ahmad Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 8288 4502
Fax
Email
movahed.m@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farkhondeh Amin Shokravi
Position
Ph.D. of Health education
Other areas of specialty/work
Street address
No 14115-111, Jalal Al Ahmad Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 8288 4506
Fax
Email
aminsh_f@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Hediah Shahhatami
Position
MSc student of Health education
Other areas of specialty/work
Street address
No 14115-111, Jalal Al Ahmad Highway, Tehran
City
Tehran
Postal code
Phone
Fax
Email
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
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