The effectiveness of cognitive-behavioral play therapy on anxiety, depression, resilience and Symptoms of mourning in children with prolonged grief Disorder: A single- subject research
The effectiveness of cognitive-behavioral play therapy on anxiety, depression, resilience and Symptoms of mourning in children with prolonged grief Disorder
Design
The clinical trial with two-month follow-up, without blinding, is available for 3 children with prolonged grief disorder of single case study type and AB design.
Settings and conduct
This study is carried out in the office of the Cultural Vice-Chancellor of Ferdowsi University of Mashhad (Dr. Asghari Nikah's room). The sessions are conducted as 12 individual treatment sessions, once a week for 45 minutes. There are 4 questionnaires that clients must fill before intervention, three times during 12 treatment sessions (fourth, eighth and twelfth sessions) and one month and two months after the end of treatment.
Participants/Inclusion and exclusion criteria
The age range is between 7 and 11 years, having lost at least one first-degree relative in the past year and meeting the criteria for prolonged bereavement disorder, according to the DSM-5-TR criteria, and having a conscious and voluntary willingness to participate in the research, the exclusion criteria of having physical diseases and significant mental disorders such as schizophrenia, retardation (diagnosed by an expert) and unwillingness to continue treatment
Intervention groups
cognitive-behavioral play therapy
Main outcome variables
anxiety, depression, resilience and Symptoms of mourning
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221105056404N1
Registration date:2023-02-18, 1401/11/29
Registration timing:retrospective
Last update:2023-02-18, 1401/11/29
Update count:0
Registration date
2023-02-18, 1401/11/29
Registrant information
Name
Atefeh sadat Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3690 9367
Email address
atf.mousavi1995@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral play therapy on anxiety, depression, resilience and Symptoms of mourning in children with prolonged grief Disorder: A single- subject research
Public title
The effect of cognitive behavioral game therapy on long-term bereavement disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 7 and 11 years
Losing at least one first-degree relative within the past year and meeting criteria for prolonged bereavement disorder, according to criteria DSM-5-TR
They had a conscious and voluntary desire to participate in the research
Not receiving psychotherapy and medication before entering the research
Exclusion criteria:
Having significant physical and mental illnesses such as schizophrenia, retardation (with expert diagnosis)
Reluctance to continue treatment
Age
From 7 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
3
Randomization (investigator's opinion)
N/A
Randomization description
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 Semnan Faculty of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Square.
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.SEMUMS.REC.1401.296
Health conditions studied
1
Description of health condition studied
Anxiety, depression, resilience and Symptoms of mourning in children with prolonged grief disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Symptoms of prolonged grief
Timepoint
Before starting the study, the fourth session, the eighth session, the twelfth session, one month after the end of the twelfth session, two months after the end of the twelfth session.
Method of measurement
Spuij et al. Inventory of Prolonged Grief for Children(IPC-G), (2011).
2
Description
Children's depression
Timepoint
Before starting the study, the fourth session, the eighth session, the twelfth session, one month after the end of the twelfth session, two months after the end of the twelfth session.
Method of measurement
Maria Kovacs, Children Depression Inventory (1958)
3
Description
Children's anxiety
Timepoint
Before starting the study, the fourth session, the eighth session, the twelfth session, one month after the end of the twelfth session, two months after the end of the twelfth session.
Before starting the study, the fourth session, the eighth session, the twelfth session, one month after the end of the twelfth session, two months after the end of the twelfth session.
Method of measurement
Surzykiewicz, Konaszewski and Wagneild (2018) Resilience Scale Short Form.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive-behavioral play therapy, 12 individual therapy sessions, (each session for 45 minutes), at the interval of therapy sessions once a week. Executive protocol based on the model taken from the book combining play therapy with cognitive behavior therapy by Athena Dors (2009), the book 101 play therapy techniques written by Heidi, Gerard Kadusen and Shafer Charles E. (1997).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Office of Dr. Asghari Nikah (Cultural Management and Voluntary Activities of Ferdowsi University of
Full name of responsible person
Dr. Seyed Mohsen Asghari Nikah
Street address
Cultural-Social and Student Vice-Chancellor Building, , Danesh Blvd, Ferdowsi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948963
Phone
+98 51 3880 6472
Fax
+98 51 3880 7071
Email
Farhangi@um.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Majid Mirmohammadkhani
Street address
Research and Technology Vice-Chancellor, Central Headquarters of Semnan University of Medical Sciences, Basij Blvd
City
semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8999
Fax
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Sadat Mousavi
Position
Master's student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 14, the first intersection on the left, Tos 39, Tos Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9198856177
Phone
+98 51 3690 9367
Email
atf.mousavi1995@semnan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Sadat Mousavi
Position
Master's student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 14, the first intersection on the left, Tos 39, Tos Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9198856177
Phone
+98 51 3690 9367
Email
atf.mousavi1995@semnan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Sadat Mousavi
Position
Master's student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 14, the first intersection on the left, Tos 39, Tos Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9198856177
Phone
+98 51 3690 9367
Email
atf.mousavi1995@semnan.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
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
Title and more details about the data/document
The general results of the research will be published as a scientific article.
When the data will become available and for how long
The documents and research results will probably be published in 2023-2024.
To whom data/document is available
The complete document of the research will be provided to Semnan Faculty of Psychology. The results of the research will be provided to researchers in the form of articles.
Under which criteria data/document could be used
The results can be used by mentioning the number and type of the community and the research sample as well as the intervention carried out.
From where data/document is obtainable
Faculty of Psychology and Educational Sciences, Semnan University, Center for Information and Scientific Documents of the country (Iran Doc) or send a message to the researcher
What processes are involved for a request to access data/document
Visit Iran Doc or Semnan University library in person or send an email to the researcher one week later (atf.mousavi1995@semnan.ac.ir)