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

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ClinicalTrials.gov Identifier: NCT03472222
Recruitment Status : Completed
First Posted : March 21, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
Arsha Vidya Tirtha
Warwick Research Services
Information provided by (Responsible Party):
NMP Medical Research Institute

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
Drug Abuse Behavioral: Arsha Vidya program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Quasi 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 : February 21, 2018
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : September 6, 2018

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Craving [ Time Frame: change from baseline to 12-weeks ]
    Frequency, intensity and duration of craving assessed visual analogue Scale



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472222


Locations
India
NMP Medical Reserach Institute
Jaipur, Rajasthan, India
Sponsors and Collaborators
NMP Medical Research Institute
Arsha Vidya Tirtha
Warwick Research Services
Investigators
Study Chair: Brahmaparananda Saraswati Arsha Vidya Tirtha
Study Director: Neha Sharma, PhD Warwick Research Services
Principal Investigator: Divya Gaur NMP Medical Research Institute, India

Responsible Party: NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT03472222     History of Changes
Other Study ID Numbers: NMP/10122
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
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
Chemically-Induced Disorders
Mental Disorders