UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052542 |
|---|---|
| Receipt number | R000059880 |
| Scientific Title | The Effectiveness Of A Pubertal Preparedness Intervention Among Adolescent Boys: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2024/03/31 04:14:36 |
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Basic information
Public title
The Effectiveness Of A Pubertal Preparedness Intervention Among Adolescent Boys: A Randomized Controlled Trial
Acronym
The Effectiveness Of A Pubertal Preparedness Intervention Among Adolescent Boys: A Randomized Controlled Trial
Scientific Title
The Effectiveness Of A Pubertal Preparedness Intervention Among Adolescent Boys: A Randomized Controlled Trial
Scientific Title:Acronym
The Effectiveness Of A Pubertal Preparedness Intervention Among Adolescent Boys: A Randomized Controlled Trial
Region
| Asia(except Japan) |
Condition
Condition
Pubertal awareness among Adolescent boys
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of pubertal education program among adolescent boys.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
To assess the efficacy of pubertal education among adolescent boys by pubertal development scale and quality of life scale. This outcome will be measured within 6 months.
Key secondary outcomes
Pubertal development,
Quality of life of the adolescent boys,
psychological well-being.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Experimental group will receive Pubertal Education Intervention. This group will receive education about puberty in about 5 sessions, each session will be of 45-60minutes and will be provided once a week.
Interventions/Control_2
Control group will receive Treatment As Usual. This group will receive an overview about pubertal changes before a follow-up session and post assessment.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male
Key inclusion criteria
The participants who did not participate in any pubertal changes intervention will be
included.
Study will include both who have achieved and who have not achieved puberty.
Key exclusion criteria
This intervention excludes all the students whose parents are not willing to give consent to
participate with their children.
Intervention excludes the population who will be physically impaired.
The participants who will not complete their assessment will be excluded from the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Dr. Ayesha |
| Middle name | |
| Last name | Aziz |
Organization
Bahria university Lahore Campus
Division name
Punjab, Lahore, Pakistan
Zip code
54782
Address
47-C civic center, Johar town, block D, Lahore.
TEL
0321-7030921
ayesha.bulc@bahria.edu.pk
Public contact
Name of contact person
| 1st name | Dr. Ayesha |
| Middle name | |
| Last name | Aziz |
Organization
Bahria university Lahore Campus
Division name
Punjab, Lahore, Pakistan
Zip code
54782
Address
47-C civic center, Johar town, block D, Lahore.
TEL
0321-7030921
Homepage URL
https://www.bahria.edu.pk/bulc/pp/dr-ayesha-aziz/
ayesha.bulc@bahria.edu.pk
Sponsor or person
Institute
Bahria university Lahore Campus
Institute
Department
Personal name
Dr. Ayesha Aziz
Funding Source
Organization
Non funding research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bahria university lahore.
Address
47-C civic center, Johar town, block D, Lahore.
Tel
042-99233408
khawer.bulc@bahria.edu.pk
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059880
