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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06004726
Other study ID # 220500003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date July 1, 2027

Study information

Verified date March 2024
Source Manipal college of Nursing
Contact Sandhya shrestha
Phone 9779846038525
Email sandhya.mconmpl2022@learner.manipal.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 210
Est. completion date July 1, 2027
Est. primary completion date July 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
School-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 )

Locations

Country Name City State
Nepal Bal mandir Mavi and Bindobasini Ma vi Pokhara Gandaki
Nepal Sandhya shrestha Pokhara Gandaki
Nepal Sandhya Shrestha Pokhara Gandaki

Sponsors (2)

Lead Sponsor Collaborator
Manipal college of Nursing Manipal University

Country where clinical trial is conducted

Nepal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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