- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06004726
"Effectiveness of School-based Substance Abuse Prevention Programme Among Adolescents .
"Effectiveness of School-based Substance Abuse Prevention Programme (SSPP) on Awareness, Attitude, Peer Pressure, and Life Skills Among Adolescents in Selected Public Schools of Pokhara, Nepal-A Cluster Randomized Trial"
The objectives of the study is to
- "to explore the perception of teachers, parents & students in the prevention of substance abuse among adolescents".
- "to develop and determine the effectiveness of a School-based substance abuse Prevention Programme (SSPP) on awareness, attitude, peer pressure, and life skills towards prevention of substance abuse".
In this study, SSPP refers to a Bilingual Multicomponent Training Programme which includes psychoeducation and video-assisted teaching to enhance awareness of substance abuse, role-play to develop a positive attitude towards prevention of substance abuse, Case based scenario to increase resistance to peer pressure and storytelling and demonstration to increase life skills towards prevention of substance abuse among adolescents of selected schools of Pokhara, Nepal.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
DETAILED METHODOLOGY
Phase I:
- Research Design: Qualitative
- Research Setting: Selected public schools of Pokhara, Nepal
- Population: Teachers, Parents, and Students of Pokhara, Nepal
- Samples: Selected Teachers, Parents & students
- Sample Size: 38 (The sample will be collected till data Saturation)
- Data collection Technique: Focus group discussion
- Data collection Tool: Focus group lead questions
- Data Analysis: Thematic analysis (Atlas.ti) Phase II Research design: Cluster Randomized Trial Randomization method: Cluster Randomization Research Setting: Selected public schools of Pokhara, Nepal Population: Adolescent students of Pokhara, Nepal Sample: Selected Adolescents, who are in the age group 13-15 years old and studying in 8th & 9th grades Variables
- Independent variables: School-based Substance abuse Prevention Programme (SSPP)
- Dependent variables: awareness, attitudes, peer pressure, and life skills related to prevention of substance abuse.
- Demographic variables: age in years, gender, religion, education/grade, family type, residence, number of siblings, education of parents, occupation of parents, sources of information, history of substance abuse in the family.
Sample size: 210
The expected outcomes of the study is to enhance awareness towards prevention of substance abuse,develop a positive attitude towards the prevention of substance abuse,develop drug refusal skills among adolescents,improve life skills and helps in th reduction of drug abuse behaviour adolescents
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sandhya shrestha
- Phone Number: 9779846038525
- Email: sandhya.mconmpl2022@learner.manipal.edu
Study Contact Backup
- Name: Binil V
- Phone Number: 9844387432
- Email: Vp.binil@manipal.edu
Study Locations
-
-
Gandaki
-
Pokhara, Gandaki, Nepal, 009771
- Enrolling by invitation
- Sandhya shrestha
-
Pokhara, Gandaki, Nepal, 00977
- Recruiting
- Bal mandir Mavi and Bindobasini Ma vi
-
Contact:
- sandhya shrestha, master
- Phone Number: 9846038525
- Email: shrestha_sandhu@yahoo.com
-
Contact:
- binil v, phD
- Phone Number: 9844387432
- Email: vp.binil@manipal.edu
-
Pokhara, Gandaki, Nepal, 00977
- Not yet recruiting
- Sandhya shrestha
-
Contact:
- Binil V
- Phone Number: 91 -9844387432
- Email: vp.binil@manipal.edu
-
Contact:
- Shashidhara YN
- Phone Number: 91-9886344627
- Email: Shashidhara.Yn@manipal.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents of 13-15 years age group.
- Those who are studying in selected public Schools of Pokhara, Nepal.
Exclusion Criteria:
o Adolescents who are not willing to provide informed consent (assent) and parental consent.
- Adolescents who do not belong to Nepal.
- Adolescents who are absent during data collection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental and control
Experimental group will get 4 module of intervention
|
Module 1 :Introduction
Module 2:
Module3:• Storytelling on Life skills Training Components (Problem solving, Emotion Management) Module 4:• Demonstration of Life skills training components (Communication skills, Decision making skills, Creative thinking skills, Stress Management strategies ) |
|
No Intervention: Control
control group will not get intervention ,Information Booklet and video assisted teaching will be given after posttest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline awareness towards substance abuse
Time Frame: Baseline,3months &6mobths
|
Awareness towards substance abuse among adolescents using structured awareness towards substance abuse using structured awareness towards substance abuse which is of 30 items multiple choice questions with one right answer & three distracters.
Higher the score higher awareness towards substance abuse
|
Baseline,3months &6mobths
|
|
Change from baseline attitude at 3 & 6 months
Time Frame: Baseline,3months & 6months
|
Attitude towards substance abuse using Alcohol & drug attitude scale which is of 28 items.minimum
score is 61 ,Higher score is 86.higher scores indicate higher attitude t towards using Alcohol and drug
|
Baseline,3months & 6months
|
|
Change from baseline peer pressure at 3months & 6months
Time Frame: Baseline,3months& 6months
|
Peer pressure towards substance abuse using peer pressure scale which is of 25 items scale.the
minimum score is 55 & higher score is more than 72.higher the score high peer pressure.
|
Baseline,3months& 6months
|
|
Change from baseline lifeskills at 3months and 6months
Time Frame: Baseline,3months & 6months
|
Life skills among adolescents using life skills evaluation questionnaire .Higher score indicates higher life skills.
|
Baseline,3months & 6months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sandhya Shrestha, Manipal
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 220500003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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