This is a 3 months randomized waiting-list controlled clinical trial comparing the efficacy of social skills training for treating nail biting behavior in children. The children will be allocated into either treatment group or waiting list group. Outcome is measured through assessment of length of nails.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303043930N19
Registration date:2013-04-09, 1392/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-09, 1392/01/20
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-02-25, 1391/12/07
Expected recruitment end date
2014-02-26, 1392/12/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of social skills training for treating children with nail biting, a randomized waiting-list controlled clinical trial
Public title
The effect of social skills training for treating nail biting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: nail biting behavior and age range of 6 to 11 years.
Exclusion criteria: children with serious disorders such as bipolar mod disorder or pervasive developmental disorders and onset or exacerbation of nail biting behavior after taking any medication.
Age
From 6 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciecnes Ethics Committee
Street address
Hafez Hospital
City
Shiraz
Postal code
Approval date
2013-02-25, 1391/12/07
Ethics committee reference number
CT-91-6449
Health conditions studied
1
Description of health condition studied
Nail Biting
ICD-10 code
F00-F99
ICD-10 code description
Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
Primary outcomes
1
Description
Lenght of nail
Timepoint
Baseline, six weeks and three months after intervention
Method of measurement
Millimeters
Secondary outcomes
empty
Intervention groups
1
Description
Waiting list
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Ghanizadeh
Street address
Hafez Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Mahnaz Molody
Position
Student Psychology
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
molodim@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
MD
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)