Substance AbuseNCT06004726
"Effectiveness of School-based Substance Abuse Prevention Programme Among Adolescents .
A study testing School-based Substance abuse Prevention Programme (SSPP) in people with Substance Abuse, run by Manipal College of Nursing at 3 sites in Nepal.
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… Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- School-based Substance abuse Prevention Programme (SSPP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesNepal
- Study dates
- 1 May 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents of 13-15 years age group.
- Those who are studying in selected public Schools of Pokhara, Nepal.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal3 sites, 3 recruiting
- Enrolling by invitation
Sandhya Shrestha
Pokhara, Gandaki, 009771
- Recruiting
Bal mandir Mavi and Bindobasini Ma vi
Pokhara, Gandaki, 00977
sandhya shrestha, master, 9846038525, shrestha_sandhu@yahoo.com
binil v, phD, 9844387432, vp.binil@manipal.edu
- Not yet recruiting
Sandhya shrestha
Pokhara, Gandaki, 00977
Binil V, 91 -9844387432, vp.binil@manipal.edu
Shashidhara YN, 91-9886344627, Shashidhara.Yn@manipal.edu
About this study
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"
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.
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
- Conditions
- Substance Abuse
- Being tested
- School-based Substance abuse Prevention Programme (SSPP)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 )
| Study group | Role | What they receive |
|---|---|---|
| Experimental and control | Experimental | Experimental group will get 4 module of intervention Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline,3months & 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 May 2024 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manipal College of Nursing
- Sponsor type
- University, hospital or other
- Collaborators
- Manipal University
- Responsible party
- Principal investigator, Sandhya Shrestha, Manipal College of Nursing
- Investigators
- Sandhya Shrestha, Principal investigator, Manipal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004726
- Sponsor's protocol ID
- 220500003
- Status last verified
- Mar 2024
- First submitted
- 13 Aug 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT06004726
- Acronym / sponsor ID
- 220500003
- Conditions
- Substance Abuse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Manipal College of NursingUniversity, hospital or other
- Collaborators
- Manipal University
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental and control | Experimental | Other: School-based Substance abuse Prevention Programme (SSPP)Experimental group will get 4 module of intervention |
| Control | No intervention | –control group will not get intervention ,Information Booklet and video assisted teaching will be given after posttest |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Adolescents of 13-15 years age group.
- Those who are studying in selected public Schools of Pokhara, Nepal.
Key exclusion criteria (3 listed)
- o Adolescents who are not willing to provide informed consent (assent) and parental consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 ) | Other | Experimental and control |
Primary outcome
Change from baseline awareness towards substance abuse
Time frame: Baseline,3months &6mobths
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
Time frame: Baseline,3months & 6months
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
Time frame: Baseline,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
Time frame: Baseline,3months & 6months
Life skills among adolescents using life skills evaluation questionnaire .Higher score indicates higher life skills.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandhya Shrestha principal investigator
Manipal
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-based Substance abuse Prevention Programme (SSPP) in people with Substance Abuse, run by Manipal College of Nursing at 3 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandhya shrestha (9779846038525, sandhya.mconmpl2022@learner.manipal.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline awareness towards substance abuse (time frame: Baseline,3months &6mobths). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.