This study is conducted to design an interventional package of spiritual psychotherapy for adolescents with conduct disorder, and investigating its validity and effectiveness and its implementation in a randomized clinical trial with a control group . In the first step , spiritual psychotherapy package is designed for adolescents with conduct disorder and its face and content validity is assessed . Then a preliminary study for 6 adolescents with conduct disorder is performed. In the second step, clinical trial is administered in the reformation and training center, so 60 adolescents aged 12 to 17 years that received conduct disorder diagnosis based on DSM-IV diagnostic criteria, are randomly assigned to the experimental or the control group and spiritual psychotherapy package is performed in 20 one-hour group sessions , two sessions per week , for the experimental group . the K-SADS-PL questionnaire is completed in both experimental and control groups in before and after intervention and 6 month after it, and findings is compared in these 3 stages between both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310139127N2
Registration date:2013-11-10, 1392/08/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-11-10, 1392/08/19
Registrant information
Name
Maryam Salmanian
Name of organization / entity
Tehran University of medical sciences, psychiatry and psychology research center
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 3540
Email address
marysal1981@gmail.com
Recruitment status
Recruitment complete
Funding source
state
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial for comparison of reducing conduct disorder symptoms by spiritual psychotherapy package in adolescents with conduct disorder
Public title
Designing, implementing and evaluating the effectiveness of spiritual psychotherapy package for adolescents with conduct disorder: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
1. the age range of participants between 12 to 17.
2. Receiving conduct disorder diagnosis based on diagnostic criteria of DSM IV
3. do not have comorbid disorders such as learning disabilities, and substance abuse
4. not using psychiatric medications
5. Obtaining informed consent from the participants and their families to participate in the research
Age
From 12 years old to 17 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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Qods street, Keshavarz Bolvar, Tehran
City
Tehran
Postal code
Approval date
2013-05-26, 1392/03/05
Ethics committee reference number
92-02-44-22220
Health conditions studied
1
Description of health condition studied
conduct disorder
ICD-10 code
F91
ICD-10 code description
Conduct disorders
Primary outcomes
1
Description
conduct disorder symptoms
Timepoint
before and after intervention and 6 month after it
Method of measurement
K-SADS-PL questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: spiritual psychotherapy package is performed in 20 one-hour group sessions , two sessions per week , for the experimental group consists of five groups with six individuals with conduct disorder by a proficient spiritual psychotherapist.
Category
Behavior
2
Description
Control group: 30 adolescents with conduct disorder who randomly assigned in control group, do not receive the intervention, it means that they do not receive spiritual psychotherapy package.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Reforming and training center in Tehran province
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Uuniversity of Medical Sciences
Full name of responsible person
Esmat Karimi
Street address
Qods street, Keshavarz Bolvar, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Uuniversity 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
Tehran University of Medical Sciences
Full name of responsible person
maryam salmanian
Position
PhD by research student
Other areas of specialty/work
Street address
Roozbeh hospital, after Lashkar Crossroads, south Kargar avenue, Tehran
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
m-salmanian@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Mohammadi
Position
Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Roozbeh hospital, after Lashkar Crossroads, south Kargar avenue, Tehran
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
mohammadimr@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Maryam Salmanian
Position
Other areas of specialty/work
Street address
Roozbeh hospital, after Lashkar Crossroads, south Kargar avenue, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
m-salmanian@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)