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

Sponsor
NMP Medical Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03472222
Collaborator
Arsha Vidya Study Centre (Other), United Research International (Other)
120
Enrollment
1
Location
1
Arm
6.5
Actual Duration (Months)
18.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Arsha Vidya program
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Quasi experimental designQuasi experimental design
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Arsha Vidya Program for Preventing Drug Abuse Among Disadvantaged Children in Urban Slums
Actual Study Start Date :
Feb 21, 2018
Actual Primary Completion Date :
Aug 30, 2018
Actual Study Completion Date :
Sep 6, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Percent days abstinent of tobacco, alcohol and drugs [change from baseline to 12-weeks]

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

Secondary Outcome Measures

  1. Well being [change from baseline to 12-weeks]

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

Other Outcome Measures

  1. Craving [change from baseline to 12-weeks]

    Frequency, intensity and duration of craving assessed visual analogue Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NMP Medical Reserach Institute Ahmedabad Gujarat India

Sponsors and Collaborators

  • NMP Medical Research Institute
  • Arsha Vidya Study Centre
  • United Research International

Investigators

  • Study Chair: Buddhatmananda Saraswati, Arsha Vidya Study Centre, India
  • Principal Investigator: Rajubhai P Odedra, NMP Medical Research Institute
  • Study Director: Divya Gaur, United Research International

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NMP Medical Research Institute
ClinicalTrials.gov Identifier:
NCT03472222
Other Study ID Numbers:
  • NMP/10122
First Posted:
Mar 21, 2018
Last Update Posted:
May 24, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Substance-Related Disorders

Study Results

No Results Posted as of May 24, 2019