Improving sleep and psychological functioning in children and adolescents suffering from ADHD and their parents; an intervention study focusing on parent’s and children’s sleep patterns
the purpose of this study is improving sleep and psychological functioning in children and adolescents suffering from ADHD and their parents. 60 ADHD children with their parents were selected in available method who having inclusion and exclusion criteria of this study. 3 groups were studied including 20 family for trial group, 20 family for control group and 20 intact family. firstly, participants complete the sleep questionnaires and then they were assigned in one of the both treatment or control groups. control group complete the daily log questionnaires for four consecutive weeks; every second week, and treatment group receives specific advice for parents’ and children’s sleep hygiene. At the end of the four-week period, participants again complete the identical series of questionnaires and the three groups were compared in sleep improvement.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202259127N1
Registration date:2012-04-04, 1391/01/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-04, 1391/01/16
Registrant information
Name
Maryam Salmanian
Name of organization / entity
Tehran University of medical sciences, psychiatry and psychology research center
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 3540
Email address
marysal1981@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-10, 1390/12/20
Expected recruitment end date
2012-09-10, 1391/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Improving sleep and psychological functioning in children and adolescents suffering from ADHD and their parents; an intervention study focusing on parent’s and children’s sleep patterns
Public title
Improving sleep and psychological functioning in children and adolescents suffering from ADHD and their parents ; an intervention study focusing on parent’s and children’s sleep patterns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. age range 6 to18 years; 2- having ADHD symptoms based on DSM IV and 3-Pharmaceutical therapy under the supervision of a psychiatrist
Exclusion criterion: having comorbid disorders such as depression, Obsession and etc
Age
From 6 years old to 18 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Teharan, Blvd Keshavarz, The Qods street
City
Tehran
Postal code
Approval date
2012-02-09, 1390/11/20
Ethics committee reference number
16524
Health conditions studied
1
Description of health condition studied
attention deficiency hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Improving sleep
Timepoint
Baseline, 2 month after intervention
Method of measurement
Insomnia Severity Index, International physicalactivity questionnaire, Daily sleep, mood, and activity log, Children’s sleep habits questionnaire – abbreviated form
Secondary outcomes
1
Description
Psychological functions
Timepoint
Baseline, 2 month after intervention
Method of measurement
Hypomania Check-List 32 , Strengths and Difficulties Questionnaire , Mood disorders questionnaire , Depression scale , Kid-screen; parent version
Intervention groups
1
Description
sleep hygiene intervention is just performed for trial group including 20 family with ADHD children; interventions for parents’ and children’s sleep hygiene is performed in two consecutive months; every month.
Category
Rehabilitation
2
Description
sleep hygiene intervention is not performed for intact group including 20 family with normal children. finally,this group is compared with trial and control groups.
Category
N/A
3
Description
sleep hygiene intervention is not performed for control group including 20 family with ADHD children. finally, trial, control and intact group are compared with each other.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry and Psychology Research Center, Roozbeh Hospital
Full name of responsible person
maryam salmanian
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs karimi
Street address
fifth floor, The Qods street, Blvd Keshavarz, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of 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
Tehran University of Medical Sciences, Psychiatry research center
Full name of responsible person
Zahra Keshavarzi
Position
MSc
Other areas of specialty/work
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
pprct@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Psychiatry and Psychology Research Center
Full name of responsible person
Mohammad Reza Mohammadi
Position
MD
Other areas of specialty/work
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN.
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
pprct@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Psychiatry and Psychology Research Center
Full name of responsible person
Maryam Salmanian
Position
MS/Researcher
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 5541 3540
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)