A comparative study of the effectiveness of adding melatonin and sleep hygiene education to the usual treatment (pharmacological and non-pharmacological treatment) in reducing the symptoms of attention deficit hyperactivity disorder in adolescents with attention deficit hyperactivity disorder and sleep phase delay syndrome.
A comparative study of the effectiveness of adding melatonin and sleep hygiene education to the usual treatment (pharmacological and non-pharmacological treatment) in reducing the symptoms of attention deficit hyperactivity disorder in adolescents with attention deficit hyperactivity disorder and sleep phase delay syndrome.
Design
A clinical trial with a randomized control group of 75 patients
Settings and conduct
The study is conducted in psychiatric clinics and on teenagers aged 12 to 18 with attention deficit hyperactivity disorder. Children in two groups will be given medicine and sleep hygiene education. Questionnaires will be filled out before, during, and after the study.
Participants/Inclusion and exclusion criteria
1. Definitive diagnosis of ADHD with DSPS 2. Age range: between 12 and 18 years 3. Informed consent to participate in the research project 4. Having minimum education (reading and writing literacy) parents for sleep training for teenagers 1. Suffering from a chronic disease physical, including diabetes, liver problems, immune system defects, and autoimmune diseases 2. Presence of major psychiatric disorders such as bipolar disorder
3. Taking medicine with side effects of sleep problems such as insomnia or hypersomnia
Intervention groups
Group 1: For each patient, 3 mg of melatonin is added to his routine treatment. This group is treated with melatonin for 5 weeks.
Group 2: This educational program as a psychoeducational program includes 5 sessions of 50 minutes.
Main outcome variables
Reducing symptoms of attention deficit hyperactivity disorder
General information
Reason for update
Acronym
ADHD
IRCT registration information
IRCT registration number:IRCT20211004052670N5
Registration date:2023-11-13, 1402/08/22
Registration timing:prospective
Last update:2023-11-13, 1402/08/22
Update count:0
Registration date
2023-11-13, 1402/08/22
Registrant information
Name
afsaneh karbasi amel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3641 1255
Email address
afsaneh_karbasi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness of adding melatonin and sleep hygiene education to the usual treatment (pharmacological and non-pharmacological treatment) in reducing the symptoms of attention deficit hyperactivity disorder in adolescents with attention deficit hyperactivity disorder and sleep phase delay syndrome.
Public title
Effectiveness of adding melatonin and sleep hygiene education to the usual treatment of attention deficit hyperactivity disorder with sleep phase delay syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of ADHD with DSPS between 12 and 18 years
Informed consent to participate in the research project
Having minimum education (reading and writing literacy) of parents for sleep training for teenagers
Exclusion criteria:
Suffering from chronic physical diseases including diabetes, liver problems, immune system defects and autoimmune diseases
Taking medicine with side effects of sleep problems such as insomnia or hypersomnia
Age
From 12 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The sample in this research consists of 75 adolescents with ADHD and sleep phase delay syndrome with the opinion of a specialist in pediatric psychiatry based on the fifth edition of the Diagnostic and Statistical Manual of Psychiatric Disorders, who are selected by available sampling. Then on 25 leaves letter A, 25 leaves letter B, and 25 leaves letter C are written and each is placed in an envelope. Then each patient is asked to choose one envelope from among the envelopes. According to the selected envelope, the patient will be allocated to one of the three groups. The size of each group is 25 people and the waiting list is also 25 people.
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Ibn Sina Street, Amin Hospital
City
Isfahan
Province
Isfehan
Postal code
8148653141
Approval date
2023-07-12, 1402/04/21
Ethics committee reference number
IR.MUI.MED.REC.1402.166
Health conditions studied
1
Description of health condition studied
Attention Deficit-Hyperactivity Disorder
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Determining the mean scores of Conners Hyperactivity Questionnaire
Timepoint
The questionnaire is administered at the baseline visit (before the intervention), after participating in sleep health education sessions and taking melatonin medicine, and then three months after the intervention is completed for follow-up.
Method of measurement
Conners Hyperactivity Questionnaire
Secondary outcomes
1
Description
Sleep quality score
Timepoint
The questionnaire is administered at the baseline visit (before the intervention), after the training sessions on sleep hygiene and the use of melatonin medication, and three months after the end of the intervention for follow-up.
Method of measurement
Petersburg Sleep Quality Questionnaire
Intervention groups
1
Description
Intervention group 1: For each patient, 3 mg of melatonin is added to his routine treatment. The chemical structure of this drug is similar to serotonin. It has a fast and complete oral absorption and reaches the plasma peak within an hour, so it is used for people with sleep delay problems. In this group, patients are first given a checklist of drug side effects, and the checklist is checked during three visits. This group is treated with melatonin for 5 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: This educational program as a psychoeducational program includes 5 50-minute sessions that are conducted by a psychologist for parents of teenagers in a group and during 5 consecutive days. The first session: In this session, how teenagers are deprived of enough sleep to Parents are explained. The second session: why teenagers are so affected by lack of sleep. In other words, the causes and factors of sleep deprivation are taught to parents in this section. The third session: The consequences of sleep deprivation in teenagers are taught to parents. The fourth and fifth sessions: How can you help teenagers get enough sleep. In these two sessions, parents are taught various effective methods to help teenagers improve their sleep quality and quantity.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Karbasi Amel Afsaneh
Street address
Ibn Sina Street, Amin Hospital
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5051
Email
Afsanehkarbasi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
غلامرضا عسگری
Street address
Hezarjaribi St. Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afsaneh Karbasi Amel
Position
Assistant Professor of Child and Adolescent Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 15, 2nd Floor, Kaj Blind Alley, Mehrdad Alley 3, 2nd Apadana Street
City
Isfahan
Province
Isfehan
Postal code
8166795471
Phone
+98 31 3641 1255
Email
afsaneh_karbasi@med.mui.ac.ir
Web page address
https://isid.research.ac.ir/Afsaneh_KarbasiAmel
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afsaneh Karbasi amel
Position
Assistant Professor of Child and Adolescent Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No.15- KAJ Ave -MEHRDAD Street-APADANA DOVOM Blvd-
City
Isfahan
Province
Isfehan
Postal code
8166795471
Phone
+98 31 3641 1255
Email
afsaneh_karbasi@med.mui.ac.ir
Web page address
https://isid.research.ac.ir/Afsaneh_KarbasiAmel
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afsaneh Karbasi Amel
Position
Assistant Professor of Child and Adolescent Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No.15- KAJ Ave -MEHRDAD Street-APADANA DOVOM Blvd-
City
Isfahan
Province
Isfehan
Postal code
8166795471No.15- KAJ
Phone
+98 31 3641 1255
Email
afsaneh_karbasi@med.mui.ac.ir
Web page address
https://isid.research.ac.ir/Afsaneh_KarbasiAmel
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