Protocol summary

Study aim
The purpose of the present study was to assess the effectiveness of a sexual education intervention program to enhance parent-adolescent sexual communication.
Design
Current study is a randomized controlled trial with a parallel group design. 102 parents of adolescent aged 13-16 years were randomly selected from 8 high schools and were assigned into intervention and control groups. Pre-assessment with questionnaire were done for both groups, then the intervention program were carried out for the intervention group. post-assessment, one week and 3-months after last intervention session, were completed for both groups and analyzed . Education program was presented for the intervention group. Control group did not receive any sexual education during the study period.
Settings and conduct
Education program was presented for the parents of intervention group, in the form of four weekly two-hour sessions. Parents were assessed at the baseline, within one week post-intervention, and 3-month follow-up to evaluate the outcome variables.
Participants/Inclusion and exclusion criteria
Inclusion criteria: living in the selected distinct; literacy of writing and reading; being biological parent and living continuously with the adolescent; agree to only one parent (father or mother) of each household participate in sessions; Exclusion criteria: participation in sexual education or counselling classes before the study.
Intervention groups
Intervention group: Sexual education program was presented only for the parents of intervention group. Control group: This group did not receive any sexual education during the study period.
Main outcome variables
parent-adolescent general communication, parental monitoring, parent-adolescent communication about sex-related topics, parent’s sexual communication skills, parent’s self-efficacy, and responsiveness to sexual communication.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120414009463N60
Registration date: 2020-10-29, 1399/08/08
Registration timing: retrospective

Last update: 2020-10-29, 1399/08/08
Update count: 0
Registration date
2020-10-29, 1399/08/08
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-01, 1397/11/12
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
2019-02-10, 1397/11/21
Actual recruitment end date
2019-07-30, 1398/05/08
Trial completion date
2019-11-30, 1398/09/09
Scientific title
Evaluation of effectiveness of a sexuality education program for parents of male adolescents: promoting of parent-adolescent sexual communication
Public title
Evaluation of effectiveness of a sexuality education program for parents of male adolescents: promoting of parent-adolescent sexual communication
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
living in the selected distinct Literacy of writing and reading being biological parent and living continuously with the adolescent agree to only one parent (father or mother) per household participate in sessions
Exclusion criteria:
participation in sexual education or counselling classes before the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 102
Actual sample size reached: 94
Randomization (investigator's opinion)
Randomized
Randomization description
A multi-stage cluster random sampling method was used in this study. Department of education distinct 4 was randomly selected by drawing lots from 4 distinct that were located in Karaj city and then eight schools were randomly selected by drawing lots from the 31 all-boys public high schools 1& 2 (4 from each cluster of high schools 1 or 2 ). Samples were selected by simple random sampling using random numbers table, so that after determining how to read and select the table numbers, subjects were assigned in to a particular group (odd- intervention, even-control). The selected group was written on a card and the card was put inside of colored pocket with numbering and continued to the last number derived from the table numbers. The first pocket was used for first one and continued to the last.
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
District 6, Keshavarz Boulevard and Ghods St.
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.TUMS.REC.1396.4433

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Parent-adolescent general communication
Timepoint
one week and 12 weeks after intervention
Method of measurement
Questionnaire

2

Description
parental monitoring
Timepoint
one week and 12 weeks after intervention
Method of measurement
Questionnaire

3

Description
parent-adolescent communication about sex-related topics (communication quantity)
Timepoint
one week and 12 weeks after intervention
Method of measurement
Questionnaire

4

Description
parent’s sexual communication skills (communication quality)
Timepoint
one week and 12 weeks after intervention
Method of measurement
Questionnaire

5

Description
parents self-efficacy
Timepoint
one week and 12 weeks after intervention
Method of measurement
Questionnaire

6

Description
parents responsiveness
Timepoint
one week and 12 weeks after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Education program was presented for the parents of intervention group, in the form of four weekly two-hour sessions. The intervention was composed of four components; Normal sexual development; General relationship and parenting; Communication about sex; Sexual risk reduction.
Category
Prevention

2

Description
Control group: The parents in control group did not receive any education related to adolescent sexuality health during the study period. In order to observe ethical issues, the presentation handout was provided for control group at the end of study.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Karaj distinct 4, all boys high schools1&2
Full name of responsible person
Pedram Javad
Street address
karaj - Mianjadeh Street- Dehghanvilla.
City
Karaj
Province
Alborz
Postal code
3145655661
Phone
+98 26 3448 0498
Email
Sh_babayanzad@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, West Nosrat Street, Tohid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
Behboodi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, West Nosrat Street, Tohid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Fax
+98 21 8836 3715
Email
Behboodi@tums.ac.ir
Web page address
https://orcid.org/0000-0002-4708-3590

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahnaz Babayanzad Ahari
Position
PhD Candidate in Reproductive Health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
Sh_babayanzad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahnaz Babayanzad Ahar
Position
Ph.D. Candidate in Reproductive Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, West Nosrat Street, Tohid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
Sh_babayanzad@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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