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NCT03472222 Clinical Trial

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

Drug Abuse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03472222
Other study ID # NMP/10122
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 21, 2018
Est. completion date September 6, 2018

Study information
Verified date January 2019
Source NMP Medical Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date September 6, 2018
Est. primary completion date August 30, 2018
Accepts healthy volunteers No
Gender All
Age group 7 Years to 13 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Arsha Vidya program
Integrated intervention program includes counselling and supportive care with the support of Arsha Vidya program

Locations
Country Name City State
India NMP Medical Reserach Institute Ahmedabad Gujarat

Sponsors (3)
Lead Sponsor Collaborator
NMP Medical Research Institute Arsha Vidya Study Centre, United Research International

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Other Craving Frequency, intensity and duration of craving assessed visual analogue Scale change from baseline to 12-weeks
Primary Percent days abstinent of tobacco, alcohol and drugs Daily Dairy was given to assess days abstinent of tobacco, alcohol and drugs change from baseline to 12-weeks
Secondary Well being The Well-Being Index (WBI), 5-item scale used to assess changes in general well-being. change from baseline to 12-weeks
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