The effect of tele psychologic - based mindful- parenting on anxiety and resilience of mothers of children ages 6-12 with attention deficit hyperactivity disorder (ADHD) during covid-19 outbreak.
This study aims to determine the effect of tele psychologic -based mindful- parenting on anxiety and resilience of mothers of children ages 6-12 with attention deficit hyperactivity disorder (ADHD) during covid-19 outbreak
Design
This study is a randomized clinical trial with two groups (experimental and control) in three phases (per-test, post-test and follow up). Forty children with ADHD diagnosis and their mothers will assign in two groups randomly (mindful parenting and control) The data will be analyzed by spss-21, using One-way ANOVA repeated measure.
Settings and conduct
Children with ADHD diagnosis, Will be referred by the child psychiatrist at Kargarnejad Hospital in Kashan, Iran. Forty children and their mothers who are eligible for inclusion and exclusion are selected. Children and their mothers will assign in two groups randomly. participants of both group fill out Beck Anxiety Inventory; Connor and Diodson resilience inventory scale; as per-test, post-test and two month after intervention as follow- up. The intervention (mindful parenting) will be done for mothers.
Participants/Inclusion and exclusion criteria
Inclusion: Children are having with attention deficit hyperactivity disorder according to a psychiatrist; age 6-12 years; receiving regular pharmacotherapy by risperidone or Ritalin; their mothers are having minimum education level of diploma. Exclusion criteria: Mother or child having intellectual disability, psychosis or major mood disorder; receiving pharmacotherapy unregularly
Intervention groups
The intervention consist of 8 sessions (each session last 90 minutes) of mindful parenting training based on Kabat-Zinn protocol in experimental group. The control group doesn’t receive any psychotherapy. Participants of both group receive pharmacotherapy (risperidone or Ritalin).
Main outcome variables
Main outcome measures variables are Resilience and Anxiety mothers
General information
Reason for update
Acronym
ADHD
IRCT registration information
IRCT registration number:IRCT20210712051858N1
Registration date:2022-01-08, 1400/10/18
Registration timing:retrospective
Last update:2022-01-08, 1400/10/18
Update count:0
Registration date
2022-01-08, 1400/10/18
Registrant information
Name
Bahman Heidarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3445 9038
Email address
heidarianc@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tele psychologic - based mindful- parenting on anxiety and resilience of mothers of children ages 6-12 with attention deficit hyperactivity disorder (ADHD) during covid-19 outbreak.
Public title
The effect of mindful- parenting on anxiety and resilience of mothers have children with attention deficit hyperactivity in covid-19 pandemic.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children are having with attention deficit hyperactivity disorder according to a psychiatrist
The age of children with ADHD is 6-12 years
receiving regular pharmacotherapy by risperidone or Ritalin
their mothers are having minimum education level of diploma
Exclusion criteria:
Mother or child having intellectual disability
psychosis or major mood disorder
Changes in the dose of medication received by the child
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
First, all the files of individuals were examined in terms of entry and exit criteria; Than, each eligible file was assigned a specific number, and using SPSS software, two sets of 20 file number were selected by simple random sampling. One group was considered the intervention group and the other included the control group.
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
Ethics Committee of Kashan University of Medical Sciences
Street address
Kargarnejad Hospital, Qutb Ravandi Blvd., kashan Town
City
kashan
Province
Isfehan
Postal code
8713783981
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.057
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder, Resilience and Anxiety
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type
Primary outcomes
1
Description
Anxiety
Timepoint
per-test, post-test and two month after intervention as follow- up
Method of measurement
Beck Anxiety Inventory (BAI)
2
Description
Resilience
Timepoint
per-test, post-test and two month after intervention as follow- up
Method of measurement
Connor and Diodson resilience inventory scale (RIS_CD)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All the children receive pharmacotherapy with either risperidone or Ritalin. The intervention group receive 8 sessions(1 session each week, each session lasting 90 minutes) of mindful parenting training based on the Kabat-Zinn protocol.
Category
Treatment - Other
2
Description
Control group: All the children receive pharmacotherapy with either risperidone or Ritalin
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kargarnejad hospital
Full name of responsible person
Fatemeh Assarian
Street address
Kashan University of Medical Sciences and Health Services, Kashan, 5Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Email
fa_assar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafsheh
Street address
Kashan University of Medical Sciences and Health Services, Kashan, 5th Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5551 0327
Email
Heidarianc@gmail.com
Grant name
Vice chancellor for research Kashan University of Medical Sciences and Health Services
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research Kashan University of Medical Sciences and Health Services
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
Kashan University of Medical Sciences
Full name of responsible person
Bahman Heidarian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Kashan University of Medical Sciences and Health Services, Kashan, 5th Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 9111
Email
Heidarianc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mahdiyeh Behbahani
Position
Mental Health expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Bushehr University of Medical Sciences and Health Services, Bushehr, Yadegar Imam St., in front of Bahman Cinema
City
Boshehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3424 2246
Email
psy.m.behbahani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Habibollah Rahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Kashan University of Medical Sciences and Health Service, Kashan, 5th Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
rahimi_h@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome or the like, can be shared
When the data will become available and for how long
Unknown date
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data will be available only to researchers working in academic and scientific institutions
From where data/document is obtainable
by Email: Heidarianc@gmail.com
What processes are involved for a request to access data/document
The person must have a letter of introduction from a university or scientific institute.