CClinicalTrials.gg
RecruitingNCT06004726Updated Mar 19, 2024

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

An interventional study of School-based Substance abuse Prevention Programme (SSPP) in Substance Abuse, sponsored by Manipal college of Nursing. Recruiting at 3 sites in Nepal. Open to participants aged 13 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Manipal college of Nursing · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
13 Years to 15 Years
Sex
All
01

Study summary

The objectives of the study is to

  1. "to explore the perception of teachers, parents \& students in the prevention of substance abuse among adolescents".
  2. "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.

Read the 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

02

Conditions studied

  • Substance Abuse
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's planned enrollment of 210 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

This is the only study on the registry with Manipal college of Nursing as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adolescents of 13-15 years age group.
  • Those who are studying in selected public Schools of Pokhara, Nepal.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    Experimental and control

    Experimental group will get 4 module of intervention

    Other: School-based Substance abuse Prevention Programme (SSPP)

  • No intervention
    Control

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

Interventions

  • OtherSchool-based Substance abuse Prevention Programme (SSPP)

    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 )

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline,3months &6mobths

  2. 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

    Time frame: Baseline,3months & 6months

  3. 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.

    Time frame: Baseline,3months& 6months

  4. Change from baseline lifeskills at 3months and 6months

    Life skills among adolescents using life skills evaluation questionnaire .Higher score indicates higher life skills.

    Time frame: Baseline,3months & 6months

07

Study locations

2 of 3 sites recruiting
  • Sandhya Shrestha
    Pokhara, Gandaki 009771, Nepal
    Enrolling by invitation
  • Bal mandir Mavi and Bindobasini Ma vi
    Pokhara, Gandaki 00977, Nepal
    Recruiting
  • Sandhya shrestha
    Pokhara, Gandaki 00977, Nepal
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06004726
Lead sponsor
Manipal college of Nursing
Collaborators
Manipal University
Responsible party
Sandhya Shrestha (Principal investigator (phD Scholar), Manipal college of Nursing) — Principal investigator
First posted
Aug 22, 2023
Start date
May 1, 2024 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Mar 19, 2024

Study contacts

Sandhya shrestha
Contact
sandhya.mconmpl2022@learner.manipal.edu
9779846038525
Binil V
Contact
Vp.binil@manipal.edu
9844387432
Sandhya Shrestha
principal investigator · Manipal

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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