Comparison of the Effectiveness of unified protocol children (UP_C) with music therapy as an adjunct treatment of UP_C in Improving Psychological Symptoms in children with emotional disorders.
Comparison of the Effectiveness of unified protocol for Children (UP_C) with Music Therapy as an adjunct Treatment of UP_C in Improving Psychological Symptoms in children with emotional disorders.
Design
Randomized, with a sample size of 90, a clinical trial with a control group.
Settings and conduct
This treatment consists of three groups (two intervention groups and one control group). One group receives UP-C treatment, Another group receives UP-C with music therapy, and the control group that does not receives treatment. This treatment is grouped and each group consists of 30 people. The music content is basically a child's music that is selected after consultation with a number of musicians and psychologist. This study is without blindness. Treatment is done at Farabi Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with emotional disorders; In the age range of six to sixteen years;
Exclusion criteria: Lack of medication during intervention; Not attending all treatment sessions
Intervention groups
Patients are randomly divided into two experimental groups and one control group, and the treatment program will be provided to experimental groups for 15 sessions, and the control group will not receive treatment. one of the experimental groups UP_C and another group UP_C plus music therapy received.
Main outcome variables
Anxiety, depression, stress.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038630N2
Registration date:2018-07-24, 1397/05/02
Registration timing:registered_while_recruiting
Last update:2018-07-24, 1397/05/02
Update count:1
Registration date
2018-07-24, 1397/05/02
Registrant information
Name
Ali Akbar Foroughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 4371
Email address
aliakbar.foroughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of unified protocol children (UP_C) with music therapy as an adjunct treatment of UP_C in Improving Psychological Symptoms in children with emotional disorders.
Public title
Comparison of the Effectiveness of UP_C with music therapy as an adjunct treatment of UP_C
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Students with emotional disorders
The age range is 16-6 years
Exclusion criteria:
Receiving the medication during the intervention
Lack of participation in all treatment sessions
Age
From 6 years old to 16 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
By simple random method individuals are assigned to the control and test groups using sealed envelope
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 kermanshah University of Medical Sciences
Street address
No 6715847141, Shahid Beheshty Ave, In Front Of Imam Ali Hospital, Building No. 2 of Medical University, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.KUMS.REC.1397.178
Health conditions studied
1
Description of health condition studied
Attention deficit-hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
2
Description of health condition studied
Social anxiety disorder of childhood
ICD-10 code
F93.2
ICD-10 code description
Social anxiety disorder of childhood
3
Description of health condition studied
Phobic anxiety disorder of childhood
ICD-10 code
F93.1
ICD-10 code description
Phobic anxiety disorder of childhood
4
Description of health condition studied
Unsocialized conduct disorder
ICD-10 code
F91.1
ICD-10 code description
Unsocialized conduct disorder
Primary outcomes
1
Description
Score in the Aggression Questionnaire
Timepoint
At the beginning of the study, after the end of the intervention and two months after the study
Method of measurement
Bass & perry the aggression Questionnaire
2
Description
Score in the teenage inventory of social skills
Timepoint
At the beginning of the study, after the end of the intervention and two months after the study
Method of measurement
Inderbitzen &, foster The teenage inventory of social skills
3
Description
Depression score in depression, anxiety, stress scale
Timepoint
At the beginning of the study, after the end of the intervention and two months after the study
Method of measurement
Depression, anxiety, stress scale (DASS)
4
Description
Anxiety score in depression, anxiety, stress scale
Timepoint
At the beginning of the study, after the end of the intervention and two months after the study
Method of measurement
Depression, anxiety, stress scale (DASS)
5
Description
Stress score in depression, anxiety, stress scale
Timepoint
At the beginning of the study, after the end of the intervention and two months after the study
Method of measurement
Depression, anxiety, stress scale (DASS)
6
Description
Score in Clinician global impression-severity scale
Timepoint
At the beginning of the study, after the end of the intervention and two months after the study
Method of measurement
Clinician global impression-severity scale (CGI-S)
7
Description
Score in the screen for child anxiety related emotional Disorders (SCARED)
Timepoint
At the beginning of the study, after the end of the intervention and two months after the study
Method of measurement
screen for child anxiety related emotional Disorders (SCARED)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: For fifteen weeks receives unified protocol children (UP-C)
Category
Behavior
2
Description
Second intervention group: For fifteen weeks receives unified protocol children (UP-C) plus music therapy
Category
Behavior
3
Description
Control group: does not receive treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah university of medical sciences
Full name of responsible person
Dr. aliakbar foroughi
Street address
Shahid Shiroudi Blvd - University Street - Nursing Blvd - School of Medicine
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6489
Email
Foroughi1792@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Building No. 2 of Medical University, Shahid Beheshti Blvd, In front of Imam Ali Hospital
City
Kermanshah
Province
Kermanshah
Postal code
4562388887
Phone
+98 83 1826 4447
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Shahram Amiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kermanshah university of medical science, medical school, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671451568
Phone
+98 83 3837 4371
Email
Shahramamiri1371@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Akbar Foroughi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah university of medical science., medical school, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671451568
Phone
+98 83 3837 4371
Email
aliakbar.foroughi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shahram Amiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kermanshah university of medical science., medical school, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
7574169936
Phone
+98 74 3246 3548
Email
shahramamiri1371@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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