Arsha Vidya Program for Preventing Drug Abuse Among Disadvantaged Children in Urban Slums

May 22, 2019 updated by: NMP Medical Research Institute
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Ahmedabad, Gujarat, India
        • NMP Medical Reserach Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parental consent to participate

Exclusion Criteria:

  • Family not involved in de-addiction program
  • Planning to move the area
  • Mental incapacity to consent or participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arsha Vidya Program
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.
Behavioral: Arsha Vidya program
Integrated intervention program includes counselling and supportive care with the support of Arsha Vidya program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline to 12-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Well being
Time Frame: change from baseline to 12-weeks
The Well-Being Index (WBI), 5-item scale used to assess changes in general well-being.
change from baseline to 12-weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Craving
Time Frame: change from baseline to 12-weeks
Frequency, intensity and duration of craving assessed visual analogue Scale
change from baseline to 12-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMP Medical Research Institute

Collaborators

Arsha Vidya Study Centre
United Research International

Investigators

  • Principal Investigator: Rajubhai P Odedra, NMP Medical Research Institute
  • Study Director: Divya Gaur, United Research International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2018

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

September 6, 2018

Study Registration Dates

First Submitted

February 24, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMP/10122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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