The aim of this study is the examine the efficacy of Acceptance and Commitment Therapy and Positive Parenting in improving psychological symptoms in children and parents
Design
clinical trial with 2 treatment groups and a control group, with parallel, Randomized using a simple randomization technique via lottery, on 48 patients
Settings and conduct
The research site is located in a group workshop held in Tehran. After initial evaluation and random assignment to intervention and control groups, interventions will performed in weekly sessions in each group.
Participants/Inclusion and exclusion criteria
children between 5 to 7 years old; Parents between 18 to 50 years old; score of at least 25 in Child Anxiety and Depression Scale; at least a diploma degree in parents
Intervention groups
Group acceptance and commitment based therapy that is performed in 8 sessions. Positive parenting group that is performed in 8 sessions.
Main outcome variables
social skills; Mood problems (including depression and anxiety); Behavioral problems (aggression); Emotional problems (emotion regulation)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230131057286N1
Registration date:2023-02-10, 1401/11/21
Registration timing:prospective
Last update:2023-02-10, 1401/11/21
Update count:0
Registration date
2023-02-10, 1401/11/21
Registrant information
Name
Shahab Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 5548
Email address
shahabmoradie66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-12, 1401/11/23
Expected recruitment end date
2023-02-25, 1401/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Acceptance and Commitment Therapy and Positive Parenting in Improving Psychological Symptoms in children and parents
Public title
The Effectiveness of Acceptance and Commitment Therapy and Positive Parenting in Improving Psychological Symptoms in children and parents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children between 5 to 7 years old
Parents between 18 to 50 years old
score of at least 25 in Child Anxiety and Depression Scale
at least a diploma degree in parents
Exclusion criteria:
Existence of attention deficit hyperactivity disorder in the child
participate in a psychological intervention at the same time
receiving psychological treatment in the last 6 months
Having a history of severe mental disorders (psychosis, delirium, cognitive disorders) or recent drug abuse in the mother
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, people are divided into two intervention groups and one control group by simple randomization and lottery. In this method, each person is given a unique number and written down in a sheet, and his name is hidden, and randomly selected by someone outside the research, they are placed in the first intervention group, the second intervention group, and the control groups.
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 Azad University, Semnan
Street address
University Campus
City
Semnan
Province
Semnan
Postal code
۳۵۱۳۱۳۷۱۱۱
Approval date
2022-09-28, 1401/07/06
Ethics committee reference number
IR.IAU.SEMNAN.REC.1400.024
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
depression
2
Description of health condition studied
Emotional and behavioral problems in children
ICD-10 code
F98.9
ICD-10 code description
Unspecifie
3
Description of health condition studied
children social skills
ICD-10 code
F94.9
ICD-10 code description
Childhood disorder of social functioning, unspecified
4
Description of health condition studied
اضطراب
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
5
Description of health condition studied
emotion regulation
ICD-10 code
ICD-10 code description
6
Description of health condition studied
self-worth
ICD-10 code
ICD-10 code description
7
Description of health condition studied
Self-acceptance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
depression
Timepoint
At the beginning of the study and after the intervention phase (2 months later)
Method of measurement
Child Anxiety and Depression Scale
2
Description
anxiety
Timepoint
At the beginning of the study and after the intervention phase (2 months later)
Method of measurement
Child Anxiety and Depression Scale
3
Description
emotion regulation
Timepoint
At the beginning of the study and after the intervention phase (2 months later)
Method of measurement
Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
4
Description
aggression
Timepoint
At the beginning of the study and after the intervention phase (2 months later)
Method of measurement
مقیاس پرخاشگری کودکان پیش دبستانی
5
Description
social skills
Timepoint
At the beginning of the study and after the intervention phase (2 months later)
Method of measurement
Children's social skills grading system
6
Description
self-acceptance
Timepoint
At the beginning of the study and after the intervention phase (2 months later)
Method of measurement
self-acceptance questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acceptance and commitment therapy
Category
Treatment - Other
2
Description
Intervention group: positive parenting
Category
Treatment - Other
3
Description
Control group:
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kindergartens in Districts 1 to 4 of Tehran
Full name of responsible person
Elaheh Ghorbanikhah
Street address
pasdaran
City
Tehran
Province
Tehran
Postal code
۱۶۶۸۸۳۵۴۸۳
Phone
+98 912 927 3651
Email
eli.ghorbani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
shahab moradi
Street address
university street
City
semnan
Province
Semnan
Postal code
۳۵۱۳۱۳۷۱۱۱
Phone
+98 912 927 3651
Email
eli.ghorbani@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
Proportion provided by this source
100
Public or private sector
Private
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
Elaheh ghorbanikhah
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
university street
City
semnan
Province
Semnan
Postal code
۳۵۱۳۱۳۷۱۱۱
Phone
+98 912 927 3651
Email
eli.ghorbani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahab Moradi
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Campus
City
Semnan
Province
Semnan
Postal code
۳۵۱۳۱۳۷۱۱۱
Phone
+98 21 2293 5548
Fax
Email
shahabmoradie66@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elaheh ghorbanikhah
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
university street
City
semnan
Province
Semnan
Postal code
۳۵۱۳۱۳۷۱۱۱
Phone
+98 912 927 3651
Email
eli.ghorbani@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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After the articles are published, the participants' data will be published in SPSS software after the participants are not identified (using the code).
When the data will become available and for how long
It is possible to access the data after the publication of all relevant articles.
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
In order to analyze the data in review studies or at the request of the journals where the articles were published
From where data/document is obtainable
Request via email to project implementer
What processes are involved for a request to access data/document
Send an email to the project implementer and receive written confirmation via email.