The main objective: Effectiveness of Unified Protocol for Transdiagnostic Treatment (UP-C) in Children with Anxiety Disorders. Specific Objectives: Comparison of the effectiveness of UP-C and CBT on children's anxiety symptoms, children's emotion regulation, cognitive reassessment and emotional suppression in children with anxiety disorders.
Design
Randomized clinical trial (RCT) study.This research method is a pre-test, post-test, and follow-up with two experimental and control groups. Participants will be randomly assigned to two experimental and control groups.
Settings and conduct
The research site is the clinic of Iran University of Medical Sciences. After a diagnostic interview with the participants in the research and providing the necessary ethical explanations and obtaining informed consent from the child and parent of the participants enter the research. They will be randomly divided into two groups of 15 experimental and control. The experimental group receive individual sessions based on UP-C and the control group receive individual sessions of CBT. In the pre and post-test stage, participants answer the questionnaires. The questionnaires will be completed again after a three-month follow-up period.
Participants/Inclusion and exclusion criteria
Children between the ages of 8 and 12 who receive a diagnosis of anxiety disorder based on a KSADS-PL diagnostic interview and who do not take psychiatric medication to treat anxiety disorders can be included in the study.
Intervention groups
The experimental group receive Barlow unified protocol for transdiagnostic treatment (15 sessions)و and the control group receive usual treatment, that is children's cognitive behavioral therapy (16 sessions).
Main outcome variables
Symptoms and Signs of Anxiety Disorders in children, Cognitive Reassessment, Emotion Regulation, Emotional Suppression
General information
Reason for update
Acronym
UP-C
IRCT registration information
IRCT registration number:IRCT20210723051963N1
Registration date:2021-11-06, 1400/08/15
Registration timing:prospective
Last update:2021-11-06, 1400/08/15
Update count:0
Registration date
2021-11-06, 1400/08/15
Registrant information
Name
Pantea Ahadian Fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1616
Email address
pantea.ahadian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Unified Protocol for Transdiagnostic Treatment in Children with Anxiety Disorders
Public title
Effectiveness of Unified Protocol for Transdiagnostic Treatment in Children with Anxiety Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 8 and 12
Receive a diagnosis of anxiety disorder based on a KSADS-PL diagnostic interview
Do not take psychiatric medication to treat anxiety disorders
Exclusion criteria:
Co-occurrence of depressive disorder based on KSADS-PL diagnostic interview.
Existence of developmental neurological disorders such as autism spectrum disorder and mental retardation based on parental report and KSADS-PL diagnostic interview.
History of receiving psychotherapy for anxiety disorders in the last 2 years
Existence of serious suicidal ideation in KSADS-PL5 diagnostic interview.
Diagnosis or history of bipolar disorder or psychosis based on KSADS-PL diagnostic interview.
Diagnosis of externalized disorders (coping disorders, conduct and attention deficit hyperactivity disorder) based on KSADS-PL diagnostic interview.
Get a diagnosis or previous history of reading disorders
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Among the children referred to the clinic of Tehran Psychiatric Institute, children 8 to 12 years old who will be interviewed with K-SADS-PL semi-structured interview with complaints of anxiety symptoms and those children who receive a diagnosis of anxiety disorders and considering the inclusion and exclusion criteria, enter into research after obtaining informed consent. These children based on restricted randomization are divided into experimental and control groups.
Restricted randomization can be used when the researchers wish that all study groups have the same sample size. In this research, the random allocation rule of the restricted randomization method will be used. The random allocation rule is the simplest method of restricted randomization. In this method, a large block is used for the total sample size, so that at the end of the study, the balance in the number of people assigned to each group is observed. To do this, the researchers first determine the total sample size, then randomly assign a set of them to the experimental group and assign the remainder to the control group. For example, in this study, with a sample size of 30 people, 15 people for the intervention group and 15 people for the control group, a lottery bowl is placed and then the names are removed from the container randomly and replaced.
Blinding (investigator's opinion)
Single blinded
Blinding description
statistical analysis is blind to the research process so that data analysis can be done without bias.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
No 1, Mansouri Ave, Niayesh St, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613111
Approval date
2021-03-16, 1399/12/26
Ethics committee reference number
IR.IUMS.REC.1399.1433
Health conditions studied
1
Description of health condition studied
Social phobias
ICD-10 code
F40.1
ICD-10 code description
Social phobias
2
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
3
Description of health condition studied
Specific (isolated) phobias
ICD-10 code
F40.2
ICD-10 code description
Specific (isolated) phobias
4
Description of health condition studied
Separation anxiety disorder of childhood
ICD-10 code
F93.0
ICD-10 code description
Separation anxiety disorder of childhood
5
Description of health condition studied
Panic disorder
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety] without agoraphobia
6
Description of health condition studied
Agoraphobia
ICD-10 code
F40.0
ICD-10 code description
Agoraphobia
Primary outcomes
1
Description
Anxiety Symptoms in Children
Timepoint
Beginning of study, end of study, follow-up after three months
Method of measurement
Screen for Child Anxiety Related Disorders & Kiddie Schedule for Affective Disorders and Schizophrenia and
2
Description
Emotion Regulation
Timepoint
Beginning of study, end of study, follow-up after three months
Method of measurement
Emotion Regulation Questionnaire for Children and Adolescents & Children's Emotional Management Scales
3
Description
cognitive reappraisal
Timepoint
Beginning of study, end of study, follow-up after three months
Method of measurement
Emotion Regulation Questionnaire for Children and Adolescents
4
Description
expressive suppression
Timepoint
Beginning of study, end of study, follow-up after three months
Method of measurement
Emotion Regulation Questionnaire for Children and Adolescents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Unified Protocol for Transdiagnostic Treatment in Children (UP-C)