Protocol summary

Study aim
Determining Investigating the effectiveness of parental cognitive hypnotherapy on impulsivity, aggression and improving the parent-child relationship
Design
A parallel-group randomized controlled clinical trial on 30 mothers with children. Randomized block method was used for randomization.
Settings and conduct
This study is conducted in educational schools in Tehran. Mothers with children with behavioral problems are included in the study. Mothers will be randomly divided into two groups of 15 people. The experimental group will receive cognitive hypnotherapy intervention. The control group will not be affected by any intervention and will only follow the usual care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: confirming the diagnosis of parental impulsivity or aggression, reporting problems in relation to the child, and the age range of 25 to 45 years for mothers and 8 to 10 years for children. Exclusion criteria: Not participating regularly in hypnotherapy sessions, having severe mental disorders and separation of parents or relocation.
Intervention groups
The intervention group includes mothers and children who participate in 8 90-minute group sessions of cognitive hypnotherapy based on Aladdin's (2007) protocol. These sessions include mental relaxation techniques, hypnotherapy inductions and cognitive exercises to improve impulse control and reduce aggression. Also, the focus is on strengthening healthy parent-child communication and increasing self-awareness. The control group received no intervention and only continued standard care.
Main outcome variables
Impulsivity, aggression, improvement of parent-child relationship

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240905062955N1
Registration date: 2024-09-14, 1403/06/24
Registration timing: prospective

Last update: 2024-09-14, 1403/06/24
Update count: 0
Registration date
2024-09-14, 1403/06/24
Registrant information
Name
Setayesh Moradi
Name of organization / entity
Islamic Azad University, Semnan branch
Country
Iran (Islamic Republic of)
Phone
+98 21 5622 9143
Email address
as.m7.moradisetayesh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-06, 1403/07/15
Expected recruitment end date
2024-11-05, 1403/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of parental cognitive hypnotherapy on impulsivity, aggression and improving the parent-child relationship
Public title
Investigating the effectiveness of parental cognitive hypnotherapy on impulsivity, aggression and improving the parent-child relationship
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirming the diagnosis of parents' impulsivity or aggression based on standard questionnaires Report problems with the child, such as lack of effective communication or frequent conflicts The age range is 25 to 45 years for mothers and 8 to 10 years for children. Parents should be willing to attend regular hypnotherapy sessions At the time of entering the research, parents should not use drugs that affect hypnotherapy (such as sedatives or anti-anxiety drugs). Parents must be in good physical health and no chronic illness prevents them from participating in the meetings.
Exclusion criteria:
Parents who do not want to participate regularly in hypnotherapy sessions or do not participate in research sessions. Starting to take sedatives, anti-anxiety drugs or other drugs that affect the results of hypnotherapy. In the event of events such as separation of parents or relocation that can affect the parent-child relationship. If the parents have serious psychiatric problems such as severe depression, bipolar disorder, or psychotic disorders that prevent continued hypnotherapy treatment.
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, randomization method is used to assign samples to intervention and control groups. First, each participant receives a unique ID. These IDs are randomly written on cards and the cards are thrown into a large container. Then, the cards are shuffled and taken out in turn. Each ID is randomly assigned to different groups. To determine the intervention and control groups, the set of cards is divided into two groups and each group is randomly assigned to one of the groups. This process ensures that the allocation of participants to groups is done without prejudice and randomly, which reduces the possibility of bias in the research results.
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 Semnan Azad University
Street address
Islamic Azad University, University Town, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2024-07-01, 1403/04/11
Ethics committee reference number
IR.IAU.SEMNAN.REC.1403.074

Health conditions studied

1

Description of health condition studied
Parent-child relationships
ICD-10 code
Z62
ICD-10 code description
Problems related to upbringing

Primary outcomes

1

Description
Aggression
Timepoint
Before starting the intervention (pre-test) and after completing 8 intervention sessions (post-test)
Method of measurement
Shahim Aggression Questionnaire (2016)

2

Description
Impulsivity
Timepoint
Before starting the intervention (pre-test) and after completing 8 intervention sessions (post-test)
Method of measurement
Hirschfield et al.'s impulsivity scale (1965)

3

Description
Parent-child relationship
Timepoint
Before starting the intervention (pre-test) and after completing 8 intervention sessions (post-test)
Method of measurement
Pianta Parent-Child Relationship Questionnaire (1994)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this research, cognitive hypnotherapy intervention based on Aladdin's protocol (2007) will be implemented in 8 sessions of one and a half hours, twice a week for one month, as a group for mothers and their children. Each session includes mental relaxation techniques and hypnotherapy inductions, along with cognitive exercises to improve impulse control and reduce aggression. Also, the focus is on strengthening healthy parent-child communication and increasing self-awareness. Home exercises are provided between sessions to consolidate learning. The main goal of this intervention is to reduce impulsivity and aggression and improve the parent-child relationship.strengthening healthy parent-child communication and increasing self-awareness. Home exercises are provided between sessions to consolidate learning. The main goal of this intervention is to reduce impulsivity and aggression and improve the parent-child relationship.
Category
Behavior

2

Description
Control group: It usually receives no intervention and serves as a comparison group. In other words, the control group only received usual and standard care and did not benefit from the CPRT cognitive program.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
General Department of Education in Tehran
Full name of responsible person
Masoume Masoumian
Street address
Shahid Sarparast St., West Taleghani St., Palestine Square.
City
Tehran
Province
Tehran
Postal code
1416622455
Phone
+98 21 8896 1175
Email
tehran@medu.ir
Web page address
https://tehran.medu.gov.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Shahab Moradi
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
shahabmoradi66@gmail.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, Semnan branch
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, Semnan branch
Full name of responsible person
Setayesh Moradi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 3, 3rd floor, Shamshad 1 Alley, Sharifi Blvd, Hasanabad Fashafoye, Shahrari.
City
Shahrari
Province
Tehran
Postal code
1833136977
Phone
+98 21 5622 9143
Email
as.m7.moradisetayesh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Daood Nodehi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Email
davud.nodehi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Setayesh Moradi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 3, 3rd floor, Shamshad 1 Alley, Sharifi Blvd, Hasanabad Fashafoye, Shahrari.
City
Shahrari
Province
Tehran
Postal code
1833136977
Phone
+98 21 5622 9143
Email
as.m7.moradisetayesh@gmail.com

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The stages of the clinical study, such as the number of participants, the criteria for entering and exiting the research project, the sampling method, the treatment protocol, and the results of the study will be described in the thesis and article.
When the data will become available and for how long
The data can be made available one month after the results are published.
To whom data/document is available
Study data and documentation will be available to researchers and researchers working in accredited academic and scientific institutions. These people can access the data by submitting a request and after reviewing and approving the request. In addition, researchers who are working in the industry related to the research topic can also apply to receive data and documentation, provided that their request is approved. The purpose of these restrictions is to ensure the responsible and ethical use of research data and documentation.
Under which criteria data/document could be used
In order to study or conduct research by mentioning the source.
From where data/document is obtainable
If you need data, contact as.m7.moradisetayesh@gmail.com.
What processes are involved for a request to access data/document
After receiving the request and reviewing it by the main researcher, the data will be sent to the requester within a week, along with a letter of commitment stating that the data will not be published without the name of the main researcher and that the privacy and confidentiality of the research participants will be preserved.
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