Protocol summary

Summary
This study aimed to determine the impact of educational intervention based on the youth positive growth model on reduction of tendency to drug abuse in the second grade high school students in Isfahan. This intervention study is aimed at adolescent in Isfahan. The statistical population is second year high school boy and girl students in Isfahan during 2016 to 2017. The intervention program was based on positive development model of youth that is designed to develop positive growth of youth. Inclusion criteria were tendency to participate in the study and the age between 15 to 18 years, exclusion criteria were drug abuse and two sessions absence in intervention sessions. The sampling method was multistage clustering. Out of 5 education areas in Isfahan, two areas were selected. Four schools were randomly selected from each district (two girls’ schools and two boys’ schools). In each district, a girls’ school and a boys’ school were considered as control group and a girls’ school and a boys’ school were considered as intervention group. One class was selected from each school and two intervention (n=100) and control (n=100) groups, totally 200 individuals were entered into the study from two districts. The data collection tool was researcher-made questionnaire. The training program is conducted based on the youth positive growth model in the two areas of students (9 sessions), and family (3 sessions) within 12 training sessions(In each intervention group, both parents and students were trained). At the beginning, the two groups were pre-tested. After the training sessions, at the end of the academic year, post-test was done using primary questionnaire for both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062228583N1
Registration date: 2017-08-28, 1396/06/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-28, 1396/06/06
Registrant information
Name
Zoya khajedehi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 3228 1021
Email address
khajehdehi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the impact of educational interventions on reducing tendency towards addictive drug abuse in students based on the model of positive youth development
Public title
Clinical trial of comparison of the impact of performing and not performing educational intervention on tendency to drug abuse among students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having age between 15،18 years and satisfaction exclusion criteria: dissatisfaction and drug use and two sessions absence in intervention sessions
Age
From 15 years old to 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The selection of areas, schools, and classes was done using random numbers.

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
"Ethics committee of Shahid Sadoughi University of Medical Sciences and Health Services"
Street address
Yazd, Safaeeyeh, Daneshgah Blvd
City
Yazd
Postal code
741-89195
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.SSU.SPH.REC.1394.75

Health conditions studied

1

Description of health condition studied
addiction
ICD-10 code
F10-F19
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use

Primary outcomes

1

Description
" tendency to drug abuse"
Timepoint
Before intervention and six months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group 1: intervention was done in the two fields of students and parents. Students’ program was a nine-session half-hour program specific for youth positive growth including: introduction and overview of program, training self-awareness and managing anger, effective communication, brave behavior, increasing self-efficacy, coping with stress, problem solving and decision making which were done by group discussion, role playing and case study, the speech and questioning and answering. Another issues included in the program were team-making and holding exhibition, spirituality and importance of meaning in life, and encouraging teens to make a clear commitment in the presence of peers to not use drugs. Training parents was a half-hour three-session training program including the increase of children’s self-efficacy, parenting skills and making relation with children through brainstorming, lecturing, discussing and case study.
Category
Prevention

2

Description
Control group: providing educational package after doing the post-test
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari
Full name of responsible person
Salehi
Street address
alley Hedayat, Khademi crossroads, alley Hedayat (or) Bahonar St. , the alley next to the mosque, Robat avval St, Esfahan
City
Esfahan

2

Recruitment center
Name of recruitment center
Alame tabatabaye
Full name of responsible person
Rezaei
Street address
Koi Rezaee (Niroo Havaei Crossroad, 38 Dastgah- Arghavan St,The House of Isfahan- Golkhane St, Esfahan
City
Esfahan

3

Recruitment center
Name of recruitment center
Nilforoshzadeh
Full name of responsible person
Torkan
Street address
Nilforoshzadeh lane, AbozarSt, Esfahan
City
Esfahan

4

Recruitment center
Name of recruitment center
khalig fars
Full name of responsible person
Jamali
Street address
Isar St, Ghadir Blvd, Sepahan Shahr,Esfahan
City
Esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
khjedehi
Full name of responsible person
khajedehi
Street address
Daneshgah Blvd, Safaeeyeh,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
khjedehi
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
khajedehi
Full name of responsible person
khajedehi
Street address
Daneshgah Blvd, Safaeeyeh, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
khajedehi
Proportion provided by this source
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
Yazd University of Medical Sciences
Full name of responsible person
khajedehi
Position
Phd student
Other areas of specialty/work
Street address
Daneshgah Blvd, Safaeeyeh,Yazd
City
Yazd
Postal code
۷۴۱ - ۸۹۱۹۵
Phone
+98 913 365 1816
Fax
Email
khajedehizoya@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
khajedehi
Position
phd student
Other areas of specialty/work
Street address
Daneshgah Blvd, Safaeeyeh, Yazd
City
Yazd
Postal code
741 - 89195
Phone
+98 35 3123 2222
Fax
Email
khajedehizoya@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
yazd univercity
Full name of responsible person
khajedehi
Position
phd student
Other areas of specialty/work
Street address
Daneshgah Blvd, Safaeeyeh, Yazd
City
yazd
Postal code
۷۴۱ - ۸۹۱۹۵
Phone
+98 913 365 1816
Fax
Email
khajedehizoya@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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