The effectiveness of cognitive emotion regulation training in reducing impulsivity and addiction in children of addicts
Design
This clinical trial study will have two groups of intervention and control. The number of samples in each group will be 12 persons. Simple randomization will be done using a random number table and individually. Scores of cognitive regulation of emotion, the tendency to addiction, and impulsivity will be recorded after the end of the intervention period.
Settings and conduct
The psychiatric clinic of Islamic Azad University, Zanjan branch will be the place of experiment. In this experiment, the intervention group will receive cognitive regulation training for 3 months. Allocation concealment of the samples will be using closed envelopes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having a drug-addicted parent
High score of addiction
The low score of impulsivity
Parental satisfaction
Exclusion criteria:
Taking drugs for mental illness
Intervention groups
The sample size of this group will be 12 people. In this group, cognitive regulation training based on the protocol of cognitive regulation and emotion will be held for 10 sessions, once a week for three months.
Main outcome variables
The cognitive regulation of emotion score
The tendency to addiction score
The impulsivity score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210204050236N1
Registration date:2021-02-13, 1399/11/25
Registration timing:prospective
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
Leila Ali Hossein Maslak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 3421
Email address
maslakleila04@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Emotion cognitive regulation Training in Impulsivity and Attitude toward Addiction among Children of the addict
Public title
Emotion cognitive regulation Training in Impulsivity and Attitude toward Addiction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a drug addicted parent
High score of addiction
Low score of impulsivity
Parental satisfaction
Exclusion criteria:
Taking drugs for mental illness
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
1) Simple randomization was performed using a random number table and individually. Random even numbers were considered for the intervention group and odd numbers for the control group. Random numbers were also selected by individuals. Thus, each person selected a number from the table of random numbers. If this number was even, he would be in the intervention group, and if the selected random number was an odd number, he would be in the control group.
2) allocation concealment with using closed envelopes
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Zanjan Branch
Street address
Shahid Mansoori St., Moallem St., Etemadiyah
City
Zanjan
Province
Zanjan
Postal code
58145-45156
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.IAU.REC.1396.61
Health conditions studied
1
Description of health condition studied
Impulsivity
ICD-10 code
R45.87
ICD-10 code description
Impulsiveness
2
Description of health condition studied
Drug addiction
ICD-10 code
F19.20
ICD-10 code description
Other psychoactive substance dependence, uncomplicated
Primary outcomes
1
Description
Cognitive regulation of excitement
Timepoint
Before the start and end of the training course
Method of measurement
Based on the Gross's model
2
Description
Tendency to addiction
Timepoint
Before the start and end of the training course
Method of measurement
Based on a standard questionnaire
3
Description
Impulsivity
Timepoint
Before the start and end of the training course
Method of measurement
Based on the Bart's impulsivity questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The sample size of this group will be 12 people. In this group, cognitive regulation training based on the Gross's (2007) protocol of cognitive regulation and emotion will be held for 10 sessions, once a week for three months. The program of ten sessions will be as follows: Pre-tests and expressing the necessity of using emotion regulation in life, defining and recognizing types of emotions, training ways to increase positive experiences, ways to reduce negative emotions, identify wrong assessments and their effects on emotional states, identify the extent and method of using the inhibition strategy and examine its emotional consequences, conscious attention to the current emotion, training to re-evaluate and express positive and negative emotions, training to evaluate emotions and pay attention to the consequences of each emotion, change negative emotions, the summary educational content of past sessions and post-test implementation.
Category
Prevention
2
Description
Control group: The sample size of this group will be 12 people. There was no intervention in this group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychotherapy Clinic of Islamic Azad University, Zanjan Branch
Full name of responsible person
Leila Ali Hossein Maslak
Street address
Shahid Mansoori St., Moallem St., Etemadiyah
City
Zanjan
Province
Zanjan
Postal code
58145-45156
Phone
+98 24 3342 1001
Email
maslakleila04@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahdi Rahnema
Street address
Shahid Mansoori St., Moallem St., Etemadiyah
City
Zanjan
Province
Zanjan
Postal code
58145-45156
Phone
+98 24 3347 0293
Email
meh_rahnema@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Qamar Kiani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Mansoori St., Moallem St., Etemadiyah
City
Zanjan
Province
Zanjan
Postal code
58145-45156
Phone
+98 24 3347 0293
Email
Shaker1339@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Qamar Kiani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Mansoori St., Moallem St., Etemadiyah
City
Zanjan
Province
Zanjan
Postal code
58145-45156
Phone
+98 24 3347 0293
Email
Shaker1339@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Leila Ali Hossein Maslak
Position
Expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Mansoori St., Moallem St., Etemadiyah
City
Zanjan
Province
Zanjan
Postal code
58145-45156
Phone
+98 24 3342 1001
Email
maslakleila04@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main variables can be shared.
When the data will become available and for how long
Two years after the publication of the results.
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
The data will only be sent for new analysis.
From where data/document is obtainable
Leila Ali Hossein Maslak
What processes are involved for a request to access data/document
Send a request email to the person in charge of the experiment