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

Primary Purpose

Drug Abuse

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Arsha Vidya program
Sponsored by
NMP Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Abuse

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NMP Medical Reserach Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arsha Vidya Program

Arm Description

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.

Outcomes

Primary Outcome Measures

Percent days abstinent of tobacco, alcohol and drugs
Daily Dairy was given to assess days abstinent of tobacco, alcohol and drugs

Secondary Outcome Measures

Well being
The Well-Being Index (WBI), 5-item scale used to assess changes in general well-being.

Full Information

First Posted
February 24, 2018
Last Updated
May 22, 2019
Sponsor
NMP Medical Research Institute
Collaborators
Arsha Vidya Study Centre, United Research International
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1. Study Identification

Unique Protocol Identification Number
NCT03472222
Brief Title
Arsha Vidya Program for Preventing Drug Abuse Among Disadvantaged Children in Urban Slums
Official Title
Arsha Vidya Program for Preventing Drug Abuse Among Disadvantaged Children in Urban Slums
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
September 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Arsha Vidya Study Centre, United Research International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi experimental design
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arsha Vidya Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Arsha Vidya program
Intervention Description
Integrated intervention program includes counselling and supportive care with the support of Arsha Vidya program
Primary Outcome Measure Information:
Title
Percent days abstinent of tobacco, alcohol and drugs
Description
Daily Dairy was given to assess days abstinent of tobacco, alcohol and drugs
Time Frame
change from baseline to 12-weeks
Secondary Outcome Measure Information:
Title
Well being
Description
The Well-Being Index (WBI), 5-item scale used to assess changes in general well-being.
Time Frame
change from baseline to 12-weeks
Other Pre-specified Outcome Measures:
Title
Craving
Description
Frequency, intensity and duration of craving assessed visual analogue Scale
Time Frame
change from baseline to 12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buddhatmananda Saraswati
Organizational Affiliation
Arsha Vidya Study Centre, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rajubhai P Odedra
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Divya Gaur
Organizational Affiliation
United Research International
Official's Role
Study Director
Facility Information:
Facility Name
NMP Medical Reserach Institute
City
Ahmedabad
State/Province
Gujarat
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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