NCT06004726

Brief Summary

The objectives of the study is to

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
May 2024Jul 2027

First Submitted

Initial submission to the registry

August 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

3.2 years

First QC Date

August 13, 2023

Last Update Submit

March 17, 2024

Conditions

Substance Abuse

Outcome Measures

Primary Outcomes (4)

  • 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

    Baseline,3months &6mobths

  • 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

    Baseline,3months & 6months

  • 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.

    Baseline,3months& 6months

  • Change from baseline lifeskills at 3months and 6months

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

    Baseline,3months & 6months

Study Arms (2)

Experimental and control

EXPERIMENTAL

Experimental group will get 4 module of intervention

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

Control

NO INTERVENTION

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

Interventions

School-based Substance abuse Prevention Programme (SSPP)OTHER

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 )

Experimental and control

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Sandhya Shrestha

    Manipal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandhya shrestha

CONTACT

9779846038525sandhya.mconmpl2022@learner.manipal.edu

Binil V

CONTACT

9844387432Vp.binil@manipal.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator (phD Scholar)

Study Record Dates

First Submitted

August 13, 2023

First Posted

August 22, 2023

Study Start

May 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

NE(3)