Drug AbuseNCT03472222
Arsha Vidya Program for Preventing Drug Abuse Among Disadvantaged Children in Urban Slums
A study testing Arsha Vidya program in people with Drug Abuse, run by NMP Medical Research Institute at 1 site in India.
Trial summary
Substance abuse remain critical problems in both developed and developing countries. Under privileged communities where health and economic system is weakest, use of drugs and illicit substances starts during adolescence and young adulthood. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Drug Abuse
- What is being tested?
- Arsha Vidya program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 21 Feb 2018to 6 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parental consent to participate
Who cannot join
- Family not involved in de-addiction program
- Planning to move the area
- Mental incapacity to consent or participate
Trial locations and contacts
1 site in 1 country.
About this study
Substance abuse remain critical problems in both developed and developing countries. Under privileged communities where health and economic system is weakest, use of drugs and illicit substances starts during adolescence and young adulthood. This not just affect physical development, mental health and social integration, but also family formation and stability, deviant behaviour, sexual behaviour and involvement, educational pursuits, livelihood pursuits. Therefore, emphasises the need for preventive education at this impressionable age.
- Conditions
- Drug Abuse
- Being tested
- Arsha Vidya program
- 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.
Arsha Vidya programBehavioural
Integrated intervention program includes counselling and supportive care with the support of Arsha Vidya program
| Study group | Role | What they receive |
|---|---|---|
| Arsha Vidya Program | Experimental | Arsha Vidya outreach community program was conducted with children. An unique well-planned teaching program developed to educate Indian cultural values \& heritage to young children and adults with yoga, chants, religious and spiritual practices through stories, group activities and plays. Receives: Behavioral: Arsha Vidya program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent days abstinent of tobacco, alcohol and drugs
Daily Dairy was given to assess days abstinent of tobacco, alcohol and drugs
Measured: change from baseline to 12-weeks
Secondary outcomes (1)
Well being
The Well-Being Index (WBI), 5-item scale used to assess changes in general well-being.
Measured: change from baseline to 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start21 Feb 2018
- Primary completion30 Aug 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug 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
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi experimental design
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Arsha Vidya Study Centre, United Research International
- Responsible party
- Sponsor
- Investigators
- Buddhatmananda Saraswati, Study chair, Arsha Vidya Study Centre, IndiaRajubhai P Odedra, Principal investigator, NMP Medical Research InstituteDivya Gaur, Study director, United Research International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472222
- Sponsor's protocol ID
- NMP/10122
- Status last verified
- Jan 2019
- First submitted
- 24 Feb 2018
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arsha Vidya Program for Preventing Drug Abuse Among Disadvantaged Children in Urban Slums
- ClinicalTrials.gov ID
- NCT03472222
- Acronym / sponsor ID
- NMP/10122
- Conditions
- Drug Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Arsha Vidya Study Centre, United Research International
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 21 Mar 2018 (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.
Substance abuse remain critical problems in both developed and developing countries. Under privileged communities where health and economic system is weakest, use of drugs and illicit substances starts during adolescence and young adulthood. This not just affect physical development, mental health and social integration, but also family formation and stability, deviant behaviour, sexual behaviour and involvement, educational pursuits, livelihood pursuits. Therefore, emphasises the need for preventive education at this impressionable age.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi experimental design
| Arm | Type | Receives |
|---|---|---|
| Arsha Vidya Program | Experimental | Behavioral: Arsha Vidya programArsha Vidya outreach community program was conducted with children. An unique well-planned teaching program developed to educate Indian cultural values \& heritage to young children and adults with yoga, chants, religious and spiritual practices through stories, group activities and plays. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parental consent to participate
Key exclusion criteria (3 listed)
- Family not involved in de-addiction program
- Planning to move the area
- Mental incapacity to consent or participate
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 |
|---|---|---|
| Arsha Vidya programIntegrated intervention program includes counselling and supportive care with the support of Arsha Vidya program | Behavioural | Arsha Vidya Program |
Primary outcome
Percent days abstinent of tobacco, alcohol and drugs
Time frame: change from baseline to 12-weeks
Daily Dairy was given to assess days abstinent of tobacco, alcohol and drugs
1 secondary outcome
Well being
Time frame: change from baseline to 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Buddhatmananda Saraswati study chair
Arsha Vidya Study Centre, India
Rajubhai P Odedra principal investigator
NMP Medical Research Institute
Divya Gaur study director
United Research International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arsha Vidya program in people with Drug Abuse, run by NMP Medical Research Institute at 1 site in India.
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 1 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: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent days abstinent of tobacco, alcohol and drugs (time frame: change from baseline to 12-weeks). 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 24 May 2019.