Clinical trial NCT06004726: "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
Overall status: RECRUITING
Phase: NA
Conditions: Substance Abuse
Lead sponsor: Manipal college of Nursing
Sponsor class: OTHER
Collaborators: name: Manipal University
First posted: 2023-08-22
Enrollment: 210
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

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

Primary outcomes:
measure: Change from baseline awareness towards substance abuse
timeFrame: Baseline,3months &6mobths
measure: Change from baseline attitude at 3 & 6 months
timeFrame: Baseline,3months & 6months
measure: Change from baseline peer pressure at 3months & 6months
timeFrame: Baseline,3months& 6months
measure: Change from baseline lifeskills at 3months and 6months
timeFrame: Baseline,3months & 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Pokhara
country: Nepal
facility: Sandhya Shrestha
state: Gandaki
city: Pokhara
country: Nepal
facility: Bal mandir Mavi and Bindobasini Ma vi
state: Gandaki
city: Pokhara
country: Nepal
facility: Sandhya shrestha
state: Gandaki
Study officials:
affiliation: Manipal
name: Sandhya Shrestha
role: PRINCIPAL_INVESTIGATOR
References: