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"Effectiveness of School-based Substance Abuse Prevention Programme Among Adolescents .

Primary Purpose

Substance Abuse

Status
Recruiting
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
School-based Substance abuse Prevention Programme (SSPP)
Sponsored by
Manipal college of Nursing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse

Eligibility Criteria

13 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sandhya Shrestha
  • Bal mandir Mavi and Bindobasini Ma viRecruiting
  • Sandhya shrestha

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental and control

Control

Arm Description

Experimental group will get 4 module of intervention

control group will not get intervention ,Information Booklet and video assisted teaching will be given after posttest

Outcomes

Primary Outcome Measures

Change from baseline awareness towards substance abuse
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
Change from baseline attitude at 3 & 6 months
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
Change from baseline peer pressure at 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.
Change from baseline lifeskills at 3months and 6months
Life skills among adolescents using life skills evaluation questionnaire .Higher score indicates higher life skills.

Secondary Outcome Measures

Full Information

First Posted
August 13, 2023
Last Updated
October 18, 2023
Sponsor
Manipal college of Nursing
Collaborators
Manipal University
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1. Study Identification

Unique Protocol Identification Number
NCT06004726
Brief Title
"Effectiveness of School-based Substance Abuse Prevention Programme Among Adolescents .
Official Title
"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"
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
July 1, 2027 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manipal college of Nursing
Collaborators
Manipal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental and control
Arm Type
Experimental
Arm Description
Experimental group will get 4 module of intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
control group will not get intervention ,Information Booklet and video assisted teaching will be given after posttest
Intervention Type
Other
Intervention Name(s)
School-based Substance abuse Prevention Programme (SSPP)
Intervention Description
Module 1 :Introduction Orientation about Training Programme using PowerPoint slides Psychoeducation and Video Assisted Teaching to enhance awareness of substance abuse. Distribution of informational booklet on basics about substance abuse Module 2: Role play to develop a positive attitude towards the prevention of substance abuse. Case-based scenario to increase resistance to peer pressure. Demonstration of drug refusal techniques. 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 )
Primary Outcome Measure Information:
Title
Change from baseline awareness towards substance abuse
Description
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
Time Frame
Baseline,3months &6mobths
Title
Change from baseline attitude at 3 & 6 months
Description
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
Time Frame
Baseline,3months & 6months
Title
Change from baseline peer pressure at 3months & 6months
Description
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.
Time Frame
Baseline,3months& 6months
Title
Change from baseline lifeskills at 3months and 6months
Description
Life skills among adolescents using life skills evaluation questionnaire .Higher score indicates higher life skills.
Time Frame
Baseline,3months & 6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandhya shrestha
Phone
9779846038525
Email
sandhya.mconmpl2022@learner.manipal.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Binil V
Phone
9844387432
Email
Vp.binil@manipal.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandhya Shrestha
Organizational Affiliation
Manipal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandhya Shrestha
City
Pokhara
State/Province
Gandaki
ZIP/Postal Code
009771
Country
Nepal
Individual Site Status
Enrolling by invitation
Facility Name
Bal mandir Mavi and Bindobasini Ma vi
City
Pokhara
State/Province
Gandaki
ZIP/Postal Code
00977
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sandhya shrestha, master
Phone
9846038525
Email
shrestha_sandhu@yahoo.com
First Name & Middle Initial & Last Name & Degree
binil v, phD
Phone
9844387432
Email
vp.binil@manipal.edu
Facility Name
Sandhya shrestha
City
Pokhara
State/Province
Gandaki
ZIP/Postal Code
00977
Country
Nepal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binil V
Phone
91 -9844387432
Email
vp.binil@manipal.edu
First Name & Middle Initial & Last Name & Degree
Shashidhara YN
Phone
91-9886344627
Email
Shashidhara.Yn@manipal.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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